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Drug overview for IDACIO(CF) PEN (adalimumab-aacf):
Generic name: adalimumab-aacf (AY-da-LIM-ue-mab)
Drug class: Antipsoriatics
Therapeutic class: Analgesic, Anti-inflammatory or Antipyretic
Adalimumab, adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp and adalimumab-ryvk, recombinant DNA-derived human immunoglobulin G1 (IgG1) monoclonal antibodies, are tumor necrosis factor (TNF) inhibitors that are biologic disease-modifying antirheumatic drugs (DMARDs). Adalimumab-aacf (Idacio(R)), adalimumab-aaty (Yuflyma(R)), adalimumab-adaz (Hyrimoz(R)), adalimumab-adbm (Cyltezo(R)), adalimumab-afzb (Abrilada(R)), adalimumab-aqvh (Yusimry(R)), adalimumab-atto (Amjevita(R)), adalimumab-bwwd (Hadlima(R)), adalimumab-fkjp (Hulio(R)), and adalimumab-ryvk (Simlandi(R)) are biosimilar to adalimumab (Humira(R)). FDA defines a biosimilar as a biological product that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency.
The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies). Therefore, biosimilarity may be established even when there are formulation or minor structural differences as long as these differences are not clinically meaningful. Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological.
In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alteration or switch. Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. Of the available adalimumab biosimilars, only adalimumab-afzb (Abrilada(R)), adalimumab-adbm (Cyltezo(R)), and adalimumab-ryvk (Simlandi(R)) are designated as interchangeable with adalimumab (Humira(R)). In this monograph, unless otherwise stated, the term ''adalimumab products'' refers to adalimumab (the reference drug) and its biosimilars (adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp, and adalimumab-ryvk).
Several adalimumab biosimilars are available. Biosimilarity of these products has been demonstrated for the indications described in Table 1. Biosimilarity to originator adalimumab is additionally supported by comparative clinical studies in patients with rheumatoid arthritis (adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp), Crohn disease (adalimumab-adbm), and/or psoriasis (adalimumab-aacf, adalimumab-adaz, adalimumab-adbm, adalimumab-aqvh, adalimumab-atto, adalimumab-ryvk).
Table 1. Adalimumab Biosimilar Products and FDA-licensed Indications FDA RA JIA PsA AS CD UC Ps HS UV labele (Adult d and indica Pediat tion ric) Adalim X X X X X X X X X umab-a fzb (Abril ada(R) ) Adalim X X X X X X X X X umab-a tto (Amjev ita(R) ) Adalim X X X X X X X X X umab-a dbm (Cylte zo(R)) Adalim X X X X X X X X X umab-b wwd (Hadli ma(R)) Adalim X X X X X X X X X umab-f kjp (Hulio (R)) Adalim X X X X X X X X X umab-a daz (Hyrim oz(R)) Adalim X X X X X X X X X umab-a acf (Idaci o(R)) Adalim X X X X X X X X X umab-r yvk (Simla ndi(R) ) Adalim X X X X X X X X X umab-a aty (Yufly ma(R)) Adalim X X X X X X X X X umab-a qvh (Yusim ry(R)) Originator adalimumab is labeled for use in adults and pediatric patients >=5 years of age with UC; biosimilars are only labeled for use in adults with UC. Originator adalimumab is labeled for use in adults and pediatric patients >=12 years of age with HS; biosimilars are only labeled for use in adults with HS.
Originator adalimumab is labeled for use in adults and pediatric patients >=2 years of age with UV; biosimilars are only labeled for use in adults with UV. AS, ankylosing spondylitis; CD, Crohn disease; HS, hidradenitis suppurativa; JIA, juvenile idiopathic arthritis; Ps, plaque psoriasis; PsA, psoriatic arthritis; RA, rheumatoid arthritis; UC, ulcerative colitis ; UV, uveitis.
Generic name: adalimumab-aacf (AY-da-LIM-ue-mab)
Drug class: Antipsoriatics
Therapeutic class: Analgesic, Anti-inflammatory or Antipyretic
Adalimumab, adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp and adalimumab-ryvk, recombinant DNA-derived human immunoglobulin G1 (IgG1) monoclonal antibodies, are tumor necrosis factor (TNF) inhibitors that are biologic disease-modifying antirheumatic drugs (DMARDs). Adalimumab-aacf (Idacio(R)), adalimumab-aaty (Yuflyma(R)), adalimumab-adaz (Hyrimoz(R)), adalimumab-adbm (Cyltezo(R)), adalimumab-afzb (Abrilada(R)), adalimumab-aqvh (Yusimry(R)), adalimumab-atto (Amjevita(R)), adalimumab-bwwd (Hadlima(R)), adalimumab-fkjp (Hulio(R)), and adalimumab-ryvk (Simlandi(R)) are biosimilar to adalimumab (Humira(R)). FDA defines a biosimilar as a biological product that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency.
The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies). Therefore, biosimilarity may be established even when there are formulation or minor structural differences as long as these differences are not clinically meaningful. Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological.
In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alteration or switch. Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. Of the available adalimumab biosimilars, only adalimumab-afzb (Abrilada(R)), adalimumab-adbm (Cyltezo(R)), and adalimumab-ryvk (Simlandi(R)) are designated as interchangeable with adalimumab (Humira(R)). In this monograph, unless otherwise stated, the term ''adalimumab products'' refers to adalimumab (the reference drug) and its biosimilars (adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp, and adalimumab-ryvk).
Several adalimumab biosimilars are available. Biosimilarity of these products has been demonstrated for the indications described in Table 1. Biosimilarity to originator adalimumab is additionally supported by comparative clinical studies in patients with rheumatoid arthritis (adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp), Crohn disease (adalimumab-adbm), and/or psoriasis (adalimumab-aacf, adalimumab-adaz, adalimumab-adbm, adalimumab-aqvh, adalimumab-atto, adalimumab-ryvk).
Table 1. Adalimumab Biosimilar Products and FDA-licensed Indications FDA RA JIA PsA AS CD UC Ps HS UV labele (Adult d and indica Pediat tion ric) Adalim X X X X X X X X X umab-a fzb (Abril ada(R) ) Adalim X X X X X X X X X umab-a tto (Amjev ita(R) ) Adalim X X X X X X X X X umab-a dbm (Cylte zo(R)) Adalim X X X X X X X X X umab-b wwd (Hadli ma(R)) Adalim X X X X X X X X X umab-f kjp (Hulio (R)) Adalim X X X X X X X X X umab-a daz (Hyrim oz(R)) Adalim X X X X X X X X X umab-a acf (Idaci o(R)) Adalim X X X X X X X X X umab-r yvk (Simla ndi(R) ) Adalim X X X X X X X X X umab-a aty (Yufly ma(R)) Adalim X X X X X X X X X umab-a qvh (Yusim ry(R)) Originator adalimumab is labeled for use in adults and pediatric patients >=5 years of age with UC; biosimilars are only labeled for use in adults with UC. Originator adalimumab is labeled for use in adults and pediatric patients >=12 years of age with HS; biosimilars are only labeled for use in adults with HS.
Originator adalimumab is labeled for use in adults and pediatric patients >=2 years of age with UV; biosimilars are only labeled for use in adults with UV. AS, ankylosing spondylitis; CD, Crohn disease; HS, hidradenitis suppurativa; JIA, juvenile idiopathic arthritis; Ps, plaque psoriasis; PsA, psoriatic arthritis; RA, rheumatoid arthritis; UC, ulcerative colitis ; UV, uveitis.
DRUG IMAGES
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The following indications for IDACIO(CF) PEN (adalimumab-aacf) have been approved by the FDA:
Indications:
Ankylosing spondylitis
Crohn's disease
Hidradenitis suppurativa
Moderate to severe plaque psoriasis
Non-infectious uveitis
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Professional Synonyms:
Acne inversa
Arthritis deformans
Arthrosis deformans
Axial spondyloarthritis with radiographic sacroiliitis
Bekhterev's arthritis
Bekhterev's disease
Bekhterev's spondylitis
Colitis ulcerativa
Marie-Strumpell disease
Marie-Strumpell spondylitis
Nodose rheumatism
Noninfectious uveitis
Polyarticular JIA
Polyarticular JRA
Polyarticular juvenile chronic arthritis
Polyarticular juvenile rheumatoid arthritis
Psoriasis arthropica
Psoriatic arthropathy
Regional enteritis
Regional ileocolitis
Rheumatic arthritis
Rheumatic gout
Rheumatoid spondylitis
Rhizomelic spondylitis
Rhizomelic spondylosis
Spondylosis deformans
Strumpell-Marie disease
Suppurative hidradenitis
Verneuil's disease
Indications:
Ankylosing spondylitis
Crohn's disease
Hidradenitis suppurativa
Moderate to severe plaque psoriasis
Non-infectious uveitis
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Professional Synonyms:
Acne inversa
Arthritis deformans
Arthrosis deformans
Axial spondyloarthritis with radiographic sacroiliitis
Bekhterev's arthritis
Bekhterev's disease
Bekhterev's spondylitis
Colitis ulcerativa
Marie-Strumpell disease
Marie-Strumpell spondylitis
Nodose rheumatism
Noninfectious uveitis
Polyarticular JIA
Polyarticular JRA
Polyarticular juvenile chronic arthritis
Polyarticular juvenile rheumatoid arthritis
Psoriasis arthropica
Psoriatic arthropathy
Regional enteritis
Regional ileocolitis
Rheumatic arthritis
Rheumatic gout
Rheumatoid spondylitis
Rhizomelic spondylitis
Rhizomelic spondylosis
Spondylosis deformans
Strumpell-Marie disease
Suppurative hidradenitis
Verneuil's disease
The following dosing information is available for IDACIO(CF) PEN (adalimumab-aacf):
No enhanced Dosing information available for this drug.
Adalimumab products are administered by subcutaneous injection. Adalimumab products are intended for use under the guidance and supervision of a clinician; however, the drug may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training and with medical follow-up as necessary. Adalimumab, adalimumab-aacf, adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, and adalimumab-fkjp are commercially available in single-use prefilled syringes and single-use prefilled injection pens.
Adalimumab-aaty, adalimumab-atto, and adalimumab-bwwd are commercially available in single-use prefilled syringes and single-use prefilled autoinjectors. Adalimumab-aqvh is commercially available as a single-use prefilled injection pen. Adalimumab-ryvk is commercially available as a single-dose autoinjector.
Various packaging configurations (e.g., starter packs) may be available, depending on the specific product; contact the individual product manufacturer for more information. Some adalimumab products may not be available in presentations suitable for pediatric use, even if the product is labeled for pediatric use; consult the specific product information and manufacturer website for details. Prior to administration, adalimumab product solutions should be inspected visually for particulate matter or discoloration; if either is present, the solution should be discarded.
Adalimumab products contain no preservatives, and any unused portions of solution should be discarded. Adalimumab products should be stored at 2-8degreesC and protected from light; the prefilled syringes should be stored in the original carton until administration. The injection may be allowed to sit outside of refrigeration for 15-30 minutes prior to injection to allow the liquid to come to room temperature; the cap or cover should not be removed while the drug is warming to room temperature.
The injection should not be frozen; solutions that have been frozen should not be used. If necessary (e.g., during travel), adalimumab, adalimumab-adbm, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp, and adalimumab-ryvk may be stored at room temperature up to 25degreesC, protected from light, for a period of up to 14 days; if not used within 14 days, the drug should be discarded. Adalimumab-aacf may be stored at room temperature up to 25degreesC, protected from light, for a period of up to 28 days; if not used within 28 days, the drug should be discarded.
Adalimumab-afzb may be stored at room temperature up to 30degreesC, protected from light, for a period of up to 30 days; if not used within 30 days, the drug should be discarded. Adalimumab-aaty may be stored at room temperature up to 25degreesC, protected from light, for a period of up to 31 days; if not used within 31 days, the drug should be discarded. For adalimumab-adaz, the 10 mg/0.2
mL prefilled syringe, 20 mg/0.4 mL prefilled syringe, 40 mg/0.8 mL prefilled syringe, and 40 mg/0.8
mL prefilled pen may be stored at room temperature up to 25degreesC, protected from light, for a period of up to 21 days (discard if not used within 21 days); the 10 mg/0.1 mL prefilled syringe, 20 mg/0.2 mL prefilled syringe, 40 mg/0.4
mL prefilled syringe, 80 mg/0.8 mL prefilled syringe, 40 mg/0.4 mL prefilled pen, and 80 mg/0.8
mL prefilled pen may be stored at room temperature up to 25degreesC, protected from light, for a period of up to 14 days (discard if not used within 14 days). Subcutaneous injections of adalimumab products should be made into the anterior thighs or abdomen; however, abdominal injections should not be made within 5.18 cm (2 inches) of the umbilicus.
Injection sites should be rotated. New injections should be given at least 2.54 cm (1 inch) from an old site, and injections should not be made into areas where the skin is tender, bruised, red, or hard, or into scars or stretch marks. Injections into psoriatic lesions also should be avoided.
Adalimumab-aaty, adalimumab-atto, and adalimumab-bwwd are commercially available in single-use prefilled syringes and single-use prefilled autoinjectors. Adalimumab-aqvh is commercially available as a single-use prefilled injection pen. Adalimumab-ryvk is commercially available as a single-dose autoinjector.
Various packaging configurations (e.g., starter packs) may be available, depending on the specific product; contact the individual product manufacturer for more information. Some adalimumab products may not be available in presentations suitable for pediatric use, even if the product is labeled for pediatric use; consult the specific product information and manufacturer website for details. Prior to administration, adalimumab product solutions should be inspected visually for particulate matter or discoloration; if either is present, the solution should be discarded.
Adalimumab products contain no preservatives, and any unused portions of solution should be discarded. Adalimumab products should be stored at 2-8degreesC and protected from light; the prefilled syringes should be stored in the original carton until administration. The injection may be allowed to sit outside of refrigeration for 15-30 minutes prior to injection to allow the liquid to come to room temperature; the cap or cover should not be removed while the drug is warming to room temperature.
The injection should not be frozen; solutions that have been frozen should not be used. If necessary (e.g., during travel), adalimumab, adalimumab-adbm, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp, and adalimumab-ryvk may be stored at room temperature up to 25degreesC, protected from light, for a period of up to 14 days; if not used within 14 days, the drug should be discarded. Adalimumab-aacf may be stored at room temperature up to 25degreesC, protected from light, for a period of up to 28 days; if not used within 28 days, the drug should be discarded.
Adalimumab-afzb may be stored at room temperature up to 30degreesC, protected from light, for a period of up to 30 days; if not used within 30 days, the drug should be discarded. Adalimumab-aaty may be stored at room temperature up to 25degreesC, protected from light, for a period of up to 31 days; if not used within 31 days, the drug should be discarded. For adalimumab-adaz, the 10 mg/0.2
mL prefilled syringe, 20 mg/0.4 mL prefilled syringe, 40 mg/0.8 mL prefilled syringe, and 40 mg/0.8
mL prefilled pen may be stored at room temperature up to 25degreesC, protected from light, for a period of up to 21 days (discard if not used within 21 days); the 10 mg/0.1 mL prefilled syringe, 20 mg/0.2 mL prefilled syringe, 40 mg/0.4
mL prefilled syringe, 80 mg/0.8 mL prefilled syringe, 40 mg/0.4 mL prefilled pen, and 80 mg/0.8
mL prefilled pen may be stored at room temperature up to 25degreesC, protected from light, for a period of up to 14 days (discard if not used within 14 days). Subcutaneous injections of adalimumab products should be made into the anterior thighs or abdomen; however, abdominal injections should not be made within 5.18 cm (2 inches) of the umbilicus.
Injection sites should be rotated. New injections should be given at least 2.54 cm (1 inch) from an old site, and injections should not be made into areas where the skin is tender, bruised, red, or hard, or into scars or stretch marks. Injections into psoriatic lesions also should be avoided.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| IDACIO(CF) PEN 40 MG/0.8 ML | Maintenance | Adults inject 0.8 milliliter (40 mg) by subcutaneous route every 2 weeks in the abdomen or thigh (rotate sites) |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ADALIMUMAB-AACF(CF) PS-UV 40MG | Maintenance | Adults inject 0.8 milliliter (40 mg) by subcutaneous route every 2 weeks in the abdomen or thigh (rotate sites) |
| ADALIMUMAB-AACF(CF) CROHN 40MG | Maintenance | Adults inject 0.8 milliliter (40 mg) by subcutaneous route every 2 weeks in the abdomen or thigh (rotate sites) |
| ADALIMUMAB-AACF(CF) PEN 40 MG | Maintenance | Adults inject 0.8 milliliter (40 mg) by subcutaneous route every 2 weeks in the abdomen or thigh (rotate sites) |
The following drug interaction information is available for IDACIO(CF) PEN (adalimumab-aacf):
There are 5 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Efalizumab; Natalizumab/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Natalizumab,(1-3) efalizumab,(4) immunosuppressives, and immunomodulators all suppress the immune system. CLINICAL EFFECTS: Concurrent use of natalizumab(1-3) or efalizumab(4) with immunosuppressives or immunomodulators may result in an increased risk of infections, including progressive multifocal leukoencephalopathy (PML), an opportunistic infection caused by the JC virus (JCV). PREDISPOSING FACTORS: Previous JCV infection, longer duration of natalizumab treatment - especially if greater than 2 years, and prior or concomitant treatment with immunosuppressant medication are all independent risk factors which increase the risk for PML.(1,5) The FDA has estimated PML incidence stratified by risk factors: If anti-JCV antibody positive, no prior immunosuppressant use and natalizumab treatment less than 25 months, incidence <1/1,000. If anti-JCV antibody positive, history of prior immunosuppressant use and natalizumab treatment less than 25 months, incidence 2/1,000 If anti-JCV antibody positive, no prior immunosuppressant use and natalizumab treatment 25-48 months, incidence 4/1,000 If anti-JCV antibody positive, history of prior immunosuppressant use and natalizumab treatment 25-48 months, incidence 11/1,000. PATIENT MANAGEMENT: The US manufacturer of natalizumab states patients with Crohn's disease should not receive concurrent immunosuppressants, with the exception of limited overlap of corticosteroids, due to the increased risk for PML. For new natalizumab patients currently receiving chronic oral corticosteroids for Crohn's Disease, begin corticosteroid taper when therapeutic response to natalizumab has occurred. If corticosteroids cannot be discontinued within six months of starting natalizumab, discontinue natalizumab.(3) The US manufacturer of natalizumab states that natalizumab should not ordinarily be used in multiple sclerosis patients receiving immunosuppressants or immunomodulators due to the increased risk for PML. Immunosuppressives include, but are not limited to azathioprine, cyclophosphamide, cyclosporine, mercaptopurine, methotrexate, mitoxantrone, mycophenolate, and corticosteroids.(3,6) The UK manufacturer of natalizumab states that concurrent use with immunosuppressives or antineoplastic agents is contraindicated.(1) The Canadian manufacturer of natalizumab states that natalizumab should not be used with immunosuppressive or immunomodulatory agents.(2) The US manufacturer of certolizumab states that concurrent therapy with natalizumab is not recommended.(7) DISCUSSION: Progressive multifocal leukoencephalopathy has been reported in patients receiving concurrent natalizumab were recently or concomitantly taking immunomodulators or immunosuppressants.(1-5,8,9) |
TYSABRI |
| Abatacept/Selected Biologic DMARDs SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Possibly additive or synergistic effects on the immune system. CLINICAL EFFECTS: Concurrent use of abatacept with anakinra, rituximab, or a tumor necrosis factor (TNF) blocking agent may increase the risk of severe infections without providing any clinical benefit.(1-5) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of abatacept states that abatacept should not be used with TNF blocking agents or other biologic DMARDs. Patients transitioning from TNF blocking agent therapy to abatacept should be closely monitored for signs of infection.(1) The US manufacturers of adalimumab,(2) certolizumab,(3) golimumab,(4) and infliximab(5) state that concurrent therapy with abatacept is not recommended. DISCUSSION: In clinical trials, patients who received concurrent abatacept and TNF blocking agents experienced more infections (63% versus 43%) and more serious infections (4.4% versus 0.8%) than patients who received TNF agents alone. There was no significant additional efficacy over use of TNF agents alone.(1) In other trials, infections and serious infections were reported in 54% and 3%, respectively, of patients who received abatacept alone.(1) |
ORENCIA, ORENCIA CLICKJECT |
| Live Vaccines; Live BCG/Selected Immunosuppressive Agents SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1) CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2) PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1) |
ACAM2000 (NATIONAL STOCKPILE), ADENOVIRUS TYPE 4, ADENOVIRUS TYPE 4 AND TYPE 7, ADENOVIRUS TYPE 7, BCG (TICE STRAIN), BCG VACCINE (TICE STRAIN), DENGVAXIA, ERVEBO (NATIONAL STOCKPILE), FLUMIST TRIVALENT 2024-2025, IXCHIQ, JYNNEOS, JYNNEOS (NATIONAL STOCKPILE), M-M-R II VACCINE, PRIORIX, PROQUAD, ROTARIX, ROTATEQ, STAMARIL, VARIVAX VACCINE, VAXCHORA ACTIVE COMPONENT, VAXCHORA VACCINE, VIVOTIF, YF-VAX |
| Talimogene laherparepvec/Selected Immunosuppressants SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Talimogene laherparepvec is a live, attenuated herpes simplex virus.(1) CLINICAL EFFECTS: Concurrent use of talimogene laherparepvec in patients receiving immunosuppressive therapy may cause a life-threatening disseminated herpetic infection.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Talimogene laherparepvec is contraindicated in immunosuppressed patients.(1) The magnitude of immunocompromise and associated risks due to immunosuppressant drugs should be determined by a physician. DISCUSSION: Concurrent use of talimogene laherparepvec in patients receiving immunosuppressive therapy may cause a life-threatening disseminated herpetic infection.(1) |
IMLYGIC |
| Nadofaragene Firadenovec/Selected Immunosuppressants SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Nadofaragene firadenovec may contain low levels of replication-competent adenovirus.(1) CLINICAL EFFECTS: Concurrent use of nadofaragene firadenovec in patients receiving immunosuppressive therapy may cause disseminated adenovirus infection.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Individuals who are immunosuppressed or immune-deficient should not receive nadofaragene firadenovec.(1) DISCUSSION: Nadofaragene firadenovec is a non-replicating adenoviral vector-based gene therapy but may contain low levels of replication-competent adenovirus. Immunocompromised persons, including those receiving immunosuppressant therapy, may be at risk for disseminated adenovirus infection.(1) |
ADSTILADRIN |
There are 23 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Interleukin-1 Blocker/Tumor Necrosis Factor (TNF) Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Possibly additive or synergistic effects on the immune system. CLINICAL EFFECTS: Concurrent use of anakinra, canakinumab, or rilonacept and a tumor necrosis factor (TNF) inhibitor may increase the risk of severe infection and/or neutropenia(1-9) without providing any clinical benefit.(4-6) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of anakinra states that concurrent use of anakinra with tumor necrosis factor (TNF) blocking agents certolizumab, etanercept, and infliximab is not recommended.(1) The Canadian(2) and US(3) manufacturers of adalimumab, the US manufacturer of certolizumab,(4) and the US manufacturer of golimumab,(4) and the US manufacturer of infliximab(7) state that concurrent therapy with anakinra is not recommended. The US manufacturers of rilonacept(8) and canakinumab(9) state that concurrent use with TNF blocking agents is not recommended. Patients receiving concurrent therapy should be closely monitored for signs of infection and neutropenia.(10) DISCUSSION: Preliminary data suggest a higher rate of serious infections (7%) in patients treated concurrently with anakinra and etanercept compared to when anakinra is administered alone (2%)(1) or when etanercept is administered alone (0%).(5,8) The most common infections were bacterial pneumonia (4 cases) and cellulitis (4 cases). One patient with pulmonary fibrosis and pneumonia died from respiratory failure.(6) Preliminary data also suggest a higher rate of neutropenia (2-3%) when anakinra is administered with etanercept.(1,6) Data also suggest that the combination provides no added clinical benefit.(6) |
ARCALYST, ILARIS, KINERET |
| TNF Blockers/Azathioprine; Mercaptopurine SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown, but may involve additive or synergistic effects on the immune system. CLINICAL EFFECTS: Concurrent use of a TNF blocker with either azathioprine or mercaptopurine may increase the risk of hepatosplenic T-cell lymphoma (HSTCL), a rare but usually fatal cancer.(1-3) PREDISPOSING FACTORS: The majority of reports of hepatosplenic T cell lymphoma in patients receiving concurrent TNF blockers with either azathioprine or mercaptopurine have occurred in patients with Crohn's disease or ulcerative colitis; however, there is one report in a psoriasis patient and two reports in rheumatoid arthritis patients.(1) The majority of patients were adolescent or young males.(2) PATIENT MANAGEMENT: Patients receiving concurrent therapy with TNF blockers and either azathioprine or mercaptopurine should be counseled on the risk of developing hepatosplenic T-cell lymphoma, a rare but usually fatal cancer. They should be counseled on the signs and symptoms of malignancies such as HSTCL, which may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss. DISCUSSION: From initiation of TNF marketing to December 31, 2010, the FDA has received 28 reports of hepatosplenic T-cell lymphoma (HSTCL) in patients receiving TNF blockers: infliximab (20), etanercept (1), adalimumab (2), infliximab/adalimumab (5), certolizumab (0), golimumab (0). In 22 of these cases, the patients were also receiving azathioprine or mercaptopurine (18 with infliximab, 4 with infliximab/adalimumab).(1) |
AZASAN, AZATHIOPRINE, AZATHIOPRINE SODIUM, IMURAN, MERCAPTOPURINE, PURIXAN |
| Deferiprone/Selected Myelosuppressive Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis may increase the frequency or risk for severe toxicity.(1) CLINICAL EFFECTS: Undetected severe neutropenia or agranulocytosis may be fatal. If concurrent use of deferiprone is with clozapine, moderate neutropenia, even if due to combination therapy, may require abrupt discontinuation of clozapine resulting in decompensation of the patient's psychiatric disorder (e.g. schizophrenia). PREDISPOSING FACTORS: Agranulocytosis may be less common in patients receiving deferiprone for thalassemia, and more common in patients treated for other systemic iron overload conditions (e.g. myelodysplastic syndromes, sickle cell disease).(2,3) Inadequate monitoring appears to increase the risk for severe outcomes. Manufacturer post market surveillance found that in all fatal cases of agranulocytosis reported between 1999 and 2005, data on weekly white blood count (WBC) monitoring was missing. In three fatal cases, deferiprone was continued for two to seven days after the detection of neutropenia or agranulocytosis.(2) PATIENT MANAGEMENT: If possible, discontinue one of the drugs associated with risk for neutropenia or agranulocytosis. If alternative therapy is not available, documentation and adherence to the deferiprone monitoring protocol is essential. Baseline absolute neutrophil count (ANC) must be at least 1,500/uL prior to starting deferiprone. Monitor ANC weekly during therapy. If infection develops, interrupt deferiprone therapy and monitor ANC more frequently. If ANC is less than 1,500/uL but greater than 500/uL, discontinue deferiprone and any other drugs possibly associated with neutropenia. Initiate ANC and platelet counts daily until recovery (i.e. ANC at least 1,500/uL). If ANC is less than 500/uL, discontinue deferiprone, evaluate patient and hospitalize if appropriate. Do not resume deferiprone unless potential benefits outweigh potential risks.(1) If concurrent use of deferiprone is with clozapine, the following recommendations should be considered based on clozapine use: If a patient stabilized on clozapine therapy requires treatment with a myelosuppressive agent, the clozapine prescriber should consult with prescriber of the myelosuppressive agent (e.g. oncologist) to discuss treatment and monitoring options.(4) More frequent ANC monitoring or treatment alternatives secondary to neutropenic episodes may need to be considered. Clozapine is only available through a restricted distribution system which requires documentation of the absolute neutrophil count (ANC) prior to dispensing.(4-5) For most clozapine patients, clozapine treatment must be interrupted for a suspected clozapine-induced ANC < 1000 cells/microliter. For patients with benign ethnic neutropenia (BEN), treatment must be interrupted for suspected clozapine-induced neutropenia < 500 cells/microliter.(4) DISCUSSION: Drugs linked to this monograph have an FDA Boxed Warning for risk of neutropenia, agranulocytosis, or pancytopenia, or have > 5% risk for neutropenia and/or warnings describing risk for myelosuppression in manufacturer prescribing information.(1-4, 6-27) In pooled clinical studies submitted to the FDA, 6.1% of deferiprone patients met criteria for neutropenia and 1.7% of patients developed agranulocytosis.(1) The time to onset of agranulocytosis was highly variable with a range of 65 days to 9.2 years (median, 161 days).(3) |
DEFERIPRONE, DEFERIPRONE (3 TIMES A DAY), FERRIPROX, FERRIPROX (2 TIMES A DAY), FERRIPROX (3 TIMES A DAY) |
| Tofacitinib/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of tofacitinib and azathioprine, other biologic disease-modifying antirheumatic drugs (DMARDs), or potent immunosuppressants may result in additive or synergistic effects on the immune system.(1) CLINICAL EFFECTS: Concurrent use of tofacitinib and azathioprine, other biologic DMARDs, or potent immunosuppressants use may increase the risk of serious infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Tofacitinib should not be used concurrently with azathioprine, other biologic DMARDs, or cyclosporine.(1) Patient should be monitored for decreases in lymphocytes and neutrophils. Therapy should be adjusted based on the indication. - For all indications: If absolute neutrophil count (ANC) or lymphocyte count is less than 500 cells/mm3, discontinue tofacitinib. - For rheumatoid arthritis or psoriatic arthritis and absolute neutrophil count (ANC) 500 to 1000 cells/mm3: interrupt dosing. When ANC is greater than 1000 cells/mm3, resume Xeljanz 5 mg twice daily or Xeljanz XR 11 mg once daily. - For ulcerative colitis and ANC 500 to 1000 cells/mm3: -If taking Xeljanz 10 mg twice daily, decrease to 5 mg twice daily. When ANC is greater than 1000 cells/mm3, increase to 10 mg twice daily based on clinical response. -If taking Xeljanz 5 mg twice daily, interrupt dosing. When ANC is greater than 1000 cells/mm3, resume 5 mg twice daily. -If taking Xeljanz XR 22 mg once daily, decrease to 11 mg once daily. When ANC is greater than 1000 cells/mm3, increase to 22 mg once daily based on clinical response. -If taking Xeljanz XR 11 mg once daily, interrupt dosing. When ANC is greater than 1000 cells/mm3, resume 11 mg once daily. - For polyarticular course juvenile idiopathic arthritis (pcJIA) and ANC 500 to 1000 cells/mm3: interrupt dosing until ANC is greater than 1000 cells/mm3.(1) DISCUSSION: Concurrent use of tofacitinib and azathioprine, other biologic DMARDs, or potent immunosuppressants may increase the risk of infection.(1) |
TOFACITINIB CITRATE, XELJANZ, XELJANZ XR |
| Sarilumab; Tocilizumab/Biologic DMARDs SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of sarilumab(1) or tocilizumab(2) with other biologic DMARDs may result in additive or synergistic effects on the immune system. CLINICAL EFFECTS: Concurrent use of sarilumab(1) or tocilizumab(2) with other biologic DMARDs may increase the risk of serious infections. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The concurrent use of sarilumab(1) or tocilizumab(2) with other biologic DMARDs should be avoided. DISCUSSION: Concurrent use of sarilumab(1) or tocilizumab(2) and other biologic DMARDs may increase the risk of infection. |
ACTEMRA, ACTEMRA ACTPEN, KEVZARA, TOFIDENCE, TYENNE, TYENNE AUTOINJECTOR |
| Clozapine/Selected Myelosuppressive Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Clozapine and other myelosuppressive agents may be associated with neutropenia or agranulocytosis.(2) CLINICAL EFFECTS: Moderate neutropenia, even if due to combination therapy, may require abrupt discontinuation of clozapine resulting in decompensation of the patient's psychiatric disorder (e.g. schizophrenia). The disease treated by the myelosuppressive agent may be compromised if myelosuppression requires dose reduction, delay, or discontinuation of the myelosuppressive agent. Undetected severe neutropenia or agranulocytosis may be fatal. PREDISPOSING FACTORS: Low white blood counts prior to initiation of the myelosuppressive agent may increase risk for clinically significant neutropenia. PATIENT MANAGEMENT: If a patient stabilized on clozapine therapy requires treatment with a myelosuppressive agent, the clozapine prescriber should consult with prescriber of the myelosuppressive agent (e.g. oncologist) to discuss treatment and monitoring options.(2) More frequent ANC monitoring or treatment alternatives secondary to neutropenic episodes may need to be considered. Clozapine is only available through a restricted distribution system which requires documentation of the absolute neutrophil count (ANC) prior to dispensing.(1-2) For most clozapine patients, clozapine treatment must be interrupted for a suspected clozapine-induced ANC < 1000 cells/microliter. For patients with benign ethnic neutropenia (BEN), treatment must be interrupted for suspected clozapine-induced neutropenia < 500 cells/microliter.(2) DISCUSSION: Clozapine is only available through a restricted distribution system which requires documentation of the ANC prior to dispensing.(1) Agents linked to this interaction generally have > 5% risk for neutropenia and/or warnings describing risk for myelosuppression in manufacturer prescribing information.(3-26) Myelosuppressive agents linked to this monograph include: acalabrutinib, adalimumab, ado-trastuzumab emtansine, aflibercept, alemtuzumab, altretamine, aminoglutethimide, amphotericin B, anastrozole, anti-thymocyte globulin, aprepitant, auranofin, avelumab, axitinib, azacitidine, azathioprine, belatacept, bendamustine, bevacizumab, bexarotene, boceprevir, bortezomib, bosutinib, brentuximab, busulfan, cabazitaxel, capecitabine, carbamazepine, carboplatin, carfilzomib, carmustine, chlorambucil, cidofovir, cisplatin, cladribine, clofarabine, copanlisib, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, daunorubicin, decitabine, docetaxel, doxorubicin, erdafitinib, etoposide, everolimus, fedratinib, flucytosine, fludarabine, fluorouracil, foscarnet, fostamatinib, ganciclovir, gemcitabine, gemtuzumab ozogamicin, hydroxyurea, ibrutinib, ibritumomab, idarubicin, idecabtagene vicleucel, ifosfamide, imatinib, inebilizumab, infliximab, interferon alfa-2a, interferon alfa-2b, interferon alfacon-1, interferon gamma-1b, interferon beta-1b, irinotecan, ixabepilone, lenalidomide, levamisole, linezolid, lomustine, lurbinectedin, mechlorethamine, melphalan, mercaptopurine, methimazole, methotrexate, mitomycin, mitoxantrone, mosunetuzumab, mycophenolate, nelarabine, niraparib, nitisinone, ofatumumab, olaratumab, omacetaxine, paclitaxel, palbociclib, pegaspargase, peginterferon alfa-2a, pemetrexed, penicillamine, pentostatin, pertuzumab, pomalidomide, ponatinib, pralatrexate, procarbazine, pyrimethamine, radium Ra 223 dichloride, ribavirin, rituximab, ruxolitinib, sacituzumab govitecan-hziy, samarium Sm 153 lexidronam, satralizumab-mwge, selinexor, succimer, sulfasalazine, temozolomide, temsirolimus, teniposide, terbinafine, teriflunomide, thioguanine, thiotepa, ticlopidine, tocilizumab, topotecan, tositumomab, trabectedin, trametinib, trastuzumab, trifluridine-tipiracil, trimethadione, uracil mustard, valganciclovir, vinblastine, vincristine, vindesine, vinflunine, vinorelbine, zanubrutinib and zidovudine. |
CLOZAPINE, CLOZAPINE ODT, CLOZARIL, VERSACLOZ |
| Vedolizumab/Tumor Necrosis Factor (TNF) Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Possibly additive or synergistic effects on the immune system. CLINICAL EFFECTS: Concurrent use of vedolizumab and a tumor necrosis factor (TNF) inhibitor may increase the risk of severe infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of vedolizumab states that concurrent use of vedolizumab with tumor necrosis factor (TNF) blocking agents should be avoided.(1) DISCUSSION: Patients receiving or who had received a TNF inhibitor in the past 60 days were excluded from clinical trials for vedolizumab.(1) |
ENTYVIO, ENTYVIO PEN |
| Selected Multiple Sclerosis Agents/Immunosuppressants; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ocrelizumab or ofatumumab in combination with immunosuppressives and immune-modulators all suppress the immune system.(1,2) CLINICAL EFFECTS: Concurrent use of ocrelizumab or ofatumumab with immunosuppressive or immune-modulating agents may result in an increased risk of serious infections, such as disseminated herpetic infection or progressive multifocal leukoencephalopathy (PML), an opportunistic infection caused by the JC virus (JCV).(1,2) PREDISPOSING FACTORS: Incomplete washout of previously prescribed immunosuppressive or immune-modulating medications. PATIENT MANAGEMENT: The ocrelizumab US prescribing information states: - Ocrelizumab and other immune-modulating or immunosuppressive therapies, (including immunosuppressant doses of corticosteroids) are expected to increase the risk of immunosuppression, and the risk of additive immune system effects must be considered if these therapies are coadministered with ocrelizumab. When switching from drugs with prolonged immune effects, such as daclizumab, fingolimod, natalizumab, teriflunomide, or mitoxantrone, the duration and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects when initiating ocrelizumab.(1) The ofatumumab US prescribing information states: - Ofatumumab and other immunosuppressive therapies (including systemic corticosteroids) may have the potential for increased immunosuppressive effects and increase the risk of infection. When switching between therapies, the duration and mechanism of action of each therapy should be considered due to the potential for additive immunosuppressive effects. Ofatumumab for MS therapy has not been studied in combination with other MS agents that suppress the immune system.(2) DISCUSSION: Fatal disseminated herpes zoster and herpes simplex infections and cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients who previously received immunomodulators or immunosuppressants.(1,2) |
KESIMPTA PEN, OCREVUS, OCREVUS ZUNOVO |
| Upadacitinib/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Upadacitinib, immunosuppressives, and immunomodulators all suppress the immune system. CLINICAL EFFECTS: Concurrent use of upadacitinib with immunosuppressives or immunomodulators may result in an increased risk of serious infections. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of upadacitinib states that concurrent use of upadacitinib with immunosuppressives or immunomodulators is not recommended. DISCUSSION: Serious infections have been reported in patients receiving upadacitinib. Reported infections included pneumonia, cellulitis, tuberculosis, multidermatomal herpes zoster, oral/esophageal candidiasis, cryptococcosis. Reports of viral reactivation, including herpes virus reactivation and hepatitis B reactivation, were reported in clinical studies with upadacitinib.(1) |
RINVOQ, RINVOQ LQ |
| Inebilizumab/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inebilizumab, immunosuppressives, and immunomodulators all suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of inebilizumab with immunosuppressive or immunomodulating agents may result in myelosuppression including neutropenia resulting in an increased risk for serious infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of inebilizumab states that the concurrent use of inebilizumab with immunosuppressive agents, including systemic corticosteroids, may increase the risk of infection. If concurrent therapy is warranted, consider the risk of additive immune suppression and monitor based on prescribing information for both agents.(1) DISCUSSION: Inebilizumab has not been studied in combination with other immunosuppressants. If concurrent therapy is warranted, consider the potential for increased immunosuppressive risks from both agents. The most common infections reported by inebilizumab treated patients in the randomized and open-label clinical trial periods included urinary tract infections (20%), nasopharyngitis (13%), upper respiratory tract infections (8%), and influenza (7%). Although there been no cases of Hepatitis B virus reactivation or progressive multifocal leukoencephalopathy reported in patients taking inebilizumab, these infections have been observed in patients taking other B-cell-depleting antibodies.(1) |
UPLIZNA |
| Baricitinib/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of baricitinib with other biologic disease-modifying antirheumatic drugs (DMARDs) or potent immunosuppressants such as azathioprine or cyclosporine may result in additive or synergistic effects on the immune system. CLINICAL EFFECTS: Concurrent use of baricitinib with other biologic DMARDs or potent immunosuppressants such as azathioprine or cyclosporine may increase the risk of serious infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of baricitinib states that concurrent use of baricitinib with biologic DMARDs or potent immunosuppressants is not recommended.(1) DISCUSSION: Most patients who developed serious infections while being treated with baricitinib were on concomitant immunosuppressants like methotrexate and corticosteroids. The combination of baricitinib with other biologic DMARDs has not been studied.(1) |
OLUMIANT |
| Ponesimod/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ponesimod in combination with immunosuppressives and immune-modulators all suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of ponesimod with immunosuppressive or immune-modulating agents may result in an increased risk of serious infections, such as disseminated herpetic infection, cryptococcal infection, or progressive multifocal leukoencephalopathy (PML), an opportunistic infection caused by the JC virus (JCV).(1) PREDISPOSING FACTORS: Incomplete washout of previously prescribed immunosuppressive or immune-modulating medications. PATIENT MANAGEMENT: The ponesimod US prescribing information states ponesimod has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressive therapies. Caution should be used during concomitant administration because of the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered in order to avoid unintended additive immunosuppressive effects. Initiating treatment with ponesimod after alemtuzumab is not recommended. However, ponesimod can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.(1) DISCUSSION: Fatal disseminated herpes zoster and herpes simplex infections, cryptococcal meningitis, disseminated cryptococcal infections, and cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients who previously received immunomodulators or immunosuppressants.(1) |
PONVORY |
| Sodium Iodide I 131/Myelosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1) DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1) |
HICON, SODIUM IODIDE I-131 |
| Fingolimod/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fingolimod in combination with immunosuppressives and immune-modulators all suppress the immune system.(1-3) CLINICAL EFFECTS: Concurrent use of fingolimod with immunosuppressive or immune-modulating agents may result in an increased risk of serious infections, such as disseminated herpetic infection or progressive multifocal leukoencephalopathy (PML), an opportunistic infection caused by the JC virus (JCV).(1-3) PREDISPOSING FACTORS: Incomplete washout of previously prescribed immunosuppressive or immune-modulating medications. PATIENT MANAGEMENT: Recommendations for fingolimod regarding this interaction differ between regulatory approving agencies. The fingolimod US prescribing information states: - Antineoplastic, immune-modulating, or immunosuppressive therapies, (including corticosteroids) are expected to increase the risk of immunosuppression, and the risk of additive immune system effects must be considered if these therapies are coadministered with fingolimod. When switching from drugs with prolonged immune effects, such as natalizumab, teriflunomide or mitoxantrone, the duration and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects when initiating fingolimod.(1) The fingolimod Canadian prescribing information states: - Concurrent use with immunosuppressive or immunomodulatory agents is contraindicated due to the risk of additive immune system effects. However, co-administration of a short course of corticosteroids (up to 5 days) did not increase the overall rate of infection in patients participating Phase III clinical trials.(2) The fingolimod UK specific product characteristics states: - Fingolimod is contraindicated in patients currently receiving immunosuppressive therapies or those immunocompromised by prior therapies. When switching patients from another disease modifying therapy to Gilenya, the half-life and mode of action of the other therapy must be considered in order to avoid an additive immune effect whilst at the same time minimizing the risk of disease activation.(3) DISCUSSION: Fatal disseminated herpes zoster and herpes simplex infections and cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients who previously received immunomodulators or immunosuppressants.(1-3) |
FINGOLIMOD, GILENYA, TASCENSO ODT |
| Ozanimod/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ozanimod in combination with immunosuppressives and immune-modulators all suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of ozanimod with immunosuppressive or immune-modulating agents may result in an increased risk of serious infections, such as disseminated herpetic infection or progressive multifocal leukoencephalopathy (PML), an opportunistic infection caused by the JC virus (JCV).(1) PREDISPOSING FACTORS: Incomplete washout of previously prescribed immunosuppressive or immune-modulating medications. PATIENT MANAGEMENT: The ozanimod US prescribing information state this information regarding this interaction: -Ozanimod has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressive therapies. Caution should be used during concomitant administration because of the risk of additive immune effects during therapy and in the week following administration. When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered in order to avoid unintended additive immunosuppressive effects. Initiating treatment with ozanimod after alemtuzumab is not recommended. However, ozanimod can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.(1) DISCUSSION: Fatal disseminated herpes zoster and herpes simplex infections and cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients who previously received immunomodulators or immunosuppressants.(1) |
ZEPOSIA |
| Siponimod/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Siponimod in combination with immunosuppressives and immune-modulators all suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of siponimod with immunosuppressive or immune-modulating agents may result in an increased risk of serious infections, such as disseminated herpetic infection or progressive multifocal leukoencephalopathy (PML), an opportunistic infection caused by the JC virus (JCV).(1) PREDISPOSING FACTORS: Incomplete washout of previously prescribed immunosuppressive or immune-modulating medications. PATIENT MANAGEMENT: The siponimod US prescribing information state this information regarding this interaction: -Siponimod has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressive therapies. Caution should be used during concomitant administration because of the risk of additive immune effects during therapy and in the week following administration. When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered in order to avoid unintended additive immunosuppressive effects. Initiating treatment with siponimod after alemtuzumab is not recommended. However, siponimod can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.(1) DISCUSSION: Fatal disseminated herpes zoster and herpes simplex infections and cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients who previously received immunomodulators or immunosuppressants.(1) |
MAYZENT |
| Cladribine/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Cladribine in combination with immunosuppressives and immune-modulators all suppress the immune system.(1-2) CLINICAL EFFECTS: Concurrent use of cladribine with immunosuppressive or immune-modulating agents may result in an increased risk of serious infections, such as disseminated herpetic infection or progressive multifocal leukoencephalopathy (PML), an opportunistic infection caused by the JC virus (JCV).(1-2) PREDISPOSING FACTORS: Incomplete washout of previously prescribed immunosuppressive or immune-modulating medications. PATIENT MANAGEMENT: Recommendations for cladribine regarding this interaction differ between regulatory approving agencies. The cladribine US prescribing information states: -Concomitant use with myelosuppressive or other immunosuppressive drugs is not recommended. Acute short-term therapy with corticosteroids can be administered. In patients who have previously been treated with immunomodulatory or immunosuppressive drugs, consider potential additive effect, the mode of action, and duration of effect of the other drugs prior to initiation of cladribine.(1) The cladribine Canadian prescribing information states: -Use of cladribine in immunocompromised patients is contraindicated because of a risk of additive effects on the immune system. Acute short-term therapy with corticosteroids can be administered during cladribine treatment.(2) DISCUSSION: Fatal disseminated herpes zoster and herpes simplex infections and cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients who previously received immunomodulators or immunosuppressants.(1-2) |
CLADRIBINE, MAVENCLAD |
| IgG Antibodies and Derivatives/Efgartigimod-alfa SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod alfa may decrease concentrations of compounds that bind to the human FcRn.(3) |
VYVGART, VYVGART HYTRULO |
| Anifrolumab/Biologic Therapies SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of anifrolumab with other biologic therapies may result in additive or synergistic effects on the immune system.(1) CLINICAL EFFECTS: Concurrent use of anifrolumab with other biologic therapies may increase the risk of serious infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The concurrent use of anifrolumab with other biologic therapies is not recommended.(1) DISCUSSION: The combination of anifrolumab with other biologic therapies has not been studied and is not recommended.(1) |
SAPHNELO |
| Ritlecitinib/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ritlecitinib, immunosuppressives, and immunomodulators all suppress the immune system. CLINICAL EFFECTS: Concurrent use of ritlecitinib with immunosuppressives or immunomodulators may result in an increased risk of serious infections. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of ritlecitinib states that concurrent use of ritlecitinib with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants is not recommended.(1) DISCUSSION: Serious infections have been reported in patients receiving ritlecitinib. Reported infections included appendicitis, COVID-19 infection (including pneumonia), and sepsis. Reports of viral reactivation, including herpes virus reactivation was reported in clinical studies with ritlecitinib.(1) |
LITFULO |
| Pozelimab/IgG Antibodies and Derivatives SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Pozelimab is an IgG4P antibody. Concurrent use of immunoglobulins and other IgG-based antibodies that bind to FcRn may interfere with the FcRn recycling mechanism of pozelimab and decrease systemic exposure of pozelimab.(3) CLINICAL EFFECTS: The levels and effectiveness of pozelimab may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of pozelimab states that concomitant use of intravenous immunoglobulin should avoided with pozelimab. If concomitant use cannot be avoided, monitor patients for worsening signs and symptoms of CD55-deficient protein-losing enteropathy.(3) DISCUSSION: Clinical drug interaction studies with pozelimab have not been performed. Immunoglobulins may interfere with the endosomal FcRn recycling mechanism of monoclonal antibodies like pozelimab and decrease concentrations of pozelimab.(3) |
VEOPOZ |
| Etrasimod/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Etrasimod causes reversible sequestration of lymphocytes in lymphoid tissues, resulting in a mean 55% decrease in peripheral blood lymphocyte count at 52 weeks.(1) Other immunosuppressives and immune-modulators also suppress the immune system. CLINICAL EFFECTS: Concurrent use of etrasimod with immunosuppressive or immune-modulating agents may result in an increased risk of serious and fatal infections, such as disseminated herpetic infection, cryptococcal infection, or progressive multifocal leukoencephalopathy (PML).(1) PREDISPOSING FACTORS: Incomplete washout of previously prescribed immunosuppressive or immune-modulating medications increases the risk of adverse effects. PATIENT MANAGEMENT: The etrasimod US prescribing information states etrasimod has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressive therapies. Concomitant administration of these therapies with etrasimod should be avoided because of the risk of additive immune effects during therapy and in the weeks following administration. Etrasimod's effect on peripheral lymphocytes may persist for up to 5 weeks after discontinuation.(1) When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered in order to avoid unintended additive immunosuppressive effects.(1) DISCUSSION: Fatal disseminated herpes zoster and herpes simplex infections, cryptococcal meningitis, disseminated cryptococcal infections, and cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients treated with other sphingosine-1 phosphate receptor modulators.(1) |
VELSIPITY |
| Ropeginterferon alfa-2b/Slt Immunosuppress; Immunomodulator SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ropeginterferon alfa-2b and immunosuppressives both suppress the immune system. CLINICAL EFFECTS: Concurrent use of ropeginterferon alfa-2b with immunosuppressives may result in an increased risk of serious infections. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid concurrent use of myelosuppressive agents.(1-2) If concurrent use cannot be avoided, monitor for effects of excessive immunosuppression. DISCUSSION: In clinical trials, 20% of patients experienced leukopenia. Interferon alfa products may cause fatal or life-threatening infections.(1-2) |
BESREMI |
There are 4 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Ustekinumab/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ustekinumab, immunosuppressives, and immunomodulators all suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of ustekinumab with immunosuppressive or immunomodulating agents may result in an increased risk for serious infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of ustekinumab recommends caution because the concurrent use of ustekinumab with immunosuppressive agents may increase the risk of infection. If concurrent therapy is warranted, consider the risk of additive immune suppression and monitor based on prescribing information for both agents.(1) DISCUSSION: Ustekinumab has not been studied in combination with other immunosuppressants in psoriasis studies. In psoriatic arthritis studies, concomitant methotrexate use did not appear to influence the safety or efficacy of ustekinumab. In Crohn's disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of ustekinumab. If concurrent therapy is warranted, consider the potential for increased immunosuppressive risks from both agents.(1) The most common infections reported by ustekinumab treated patients in the clinical trial periods included nasopharyngitis(8%) and upper respiratory tract infection(5%). Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab. Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia resulting in respiratory failure or prolonged hospitalization have been reported in patients receiving ustekinumab.(1) |
STELARA |
| Ublituximab/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ublituximab, immunosuppressives, and immunomodulators all suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of ublituximab with immunosuppressive or immunomodulating agents may result in an increased risk for serious infections.(1) PREDISPOSING FACTORS: Incomplete washout of previously prescribed immunosuppressive or immune-modulating medications. PATIENT MANAGEMENT: The US manufacturer of ublituximab recommends caution because the concurrent use of ublituximab with immunomodulating or immunosuppressive agents, including immunosuppressant doses of corticosteroids, may increase the risk of infection.(1) If concurrent therapy is warranted, consider the risk of additive immune suppression and monitor based on prescribing information for both agents. When switching from agents with immune effects, the half-life and mechanism of action of these drugs must be taken into consideration in order to prevent additive immunosuppressive effects.(1) DISCUSSION: The most common infections reported by ublituximab-treated patients in the clinical trial periods included upper respiratory tract infections and urinary tract infections. Serious, including life-threatening or fatal, bacterial and viral infections were observed in patients receiving ublituximab.(1) Serious and/or fatal bacterial, fungal, and new or reactivated viral infections have been associated with other anti-CD20 B-cell depleting therapies. There were no cases of progressive multifocal leukoencephalopathy (PML) reported during the clinical trials; however, there have been reports of PML during or following completion of other anti-CD20 B-cell depleting therapies.(1) |
BRIUMVI |
| Belimumab/Biologic Therapies SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Concurrent use of belimumab with other biologic therapies may result in additive or synergistic effects on the immune system.(1) CLINICAL EFFECTS: Concurrent use of belimumab with other biologic therapies may increase the risk of serious infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The concurrent use of belimumab with other biologic therapies should be approached with caution.(1) DISCUSSION: In a randomized, double-blind, placebo-controlled trial, more patients who received belimumab and rituximab experienced serious adverse events, serious infections, and post-injection systemic reactions (22.2%, 9%, and 13.2%, respectively) than patients who received belimumab with placebo (13.9%, 2.8%, 9.7%) or standard therapy (19.7%, 5.3%, 5.3%).(1) The combination of belimumab with other biologic therapies has not been studied and should be used cautiously.(1) |
BENLYSTA |
| IgG Antibodies and Derivatives/Rozanolixizumab-noli SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3) DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3) |
RYSTIGGO |
The following contraindication information is available for IDACIO(CF) PEN (adalimumab-aacf):
Drug contraindication overview.
*None.
*None.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Active tuberculosis |
| Sepsis |
There are 20 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Basal cell carcinoma of skin |
| Chronic heart failure |
| Chronic infection |
| Demyelinating disorder |
| Extrapulmonary pneumocystosis |
| Guillain-barre syndrome |
| Hepatosplenic t-cell lymphoma |
| Inactive tuberculosis |
| Leukemia |
| Malignancy |
| Malignant lymphoma |
| Multiple sclerosis |
| Neutropenic disorder |
| Opportunistic fungal infection |
| Opportunistic viral infection |
| Pancytopenia |
| Pneumocystis jirovecii pneumonia |
| Severe infection |
| Thrombocytopenic disorder |
| Viral hepatitis B |
There are 0 moderate contraindications.
The following adverse reaction information is available for IDACIO(CF) PEN (adalimumab-aacf):
Adverse reaction overview.
Common adverse effects reported in10% or moreof patients receiving adalimumab include infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
Common adverse effects reported in10% or moreof patients receiving adalimumab include infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
There are 101 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dehydration Infection Lupus-like syndrome Skin rash Upper respiratory infection |
Abnormal hepatic function tests Accidental injury Acute myocardial infarction Agranulocytosis Asthma Atrial fibrillation Avascular necrosis of bone Biliary calculus Bronchospastic pulmonary disease Cardiac arrest Cardiac arrhythmia Cataracts Chest pain Chronic heart failure Cystitis Dyspnea Erysipelas Erythrocytosis Flu-like symptoms Fracture Fungal infection Gastrointestinal hemorrhage Hepatic necrosis Herpes zoster Hypertension Hypertensive crisis Increased alanine transaminase Ketosis Kidney stone Leg vein thrombosis Leukopenia Malignant lymphoma Monoclonal gammopathy Multiple sclerosis Palpitations Pericardial effusion Pericarditis Peripheral edema Pneumonia Pseudohypoparathyroidism Pyelonephritis Reactivated tuberculosis Secondary polycythemia Subdural intracranial hemorrhage Syncope Tachycardia Urinary tract infection |
| Rare/Very Rare |
|---|
|
Active tuberculosis Anaphylaxis Angioedema Aplastic anemia Appendicitis Autoimmune hepatitis Bacterial sepsis Basal cell carcinoma of skin Blastomycosis Cellulitis Cerebrovascular accident Cholecystitis Coccidioidomycosis Cutaneous vasculitis Deep venous thrombosis Demyelinating disorder Diverticulitis of gastrointestinal tract Drug-exacerbated psoriasis Erythema multiforme Guillain-barre syndrome Heart failure Hepatic failure Hepatitis Hepatosplenic t-cell lymphoma Histoplasmosis Hypersensitivity drug reaction Interstitial lung disease Intestinal perforation Legionnaires' disease Leukemia Listeriosis Malignancy Malignant melanoma Merkel cell carcinoma Opportunistic fungal infection Optic neuritis Pancreatitis Pancytopenia Protozoal infection Pulmonary fibrosis Pulmonary thromboembolism Reactivation of hepatitis B Sarcoidosis Squamous cell carcinoma of skin Stevens-johnson syndrome Thrombocytopenic disorder Thrombotic disorder Vasculitis Worsening of chronic heart failure |
There are 33 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Headache disorder Injection site sequelae Nausea Pharyngitis Pruritus of skin Sinusitis |
Acute abdominal pain Acute cognitive impairment Arthritis Back pain Cramps Esophagitis Gastroenteritis Hematuria Hypercholesterolemia Hyperlipidemia Impaired wound healing Injection site erythema Muscle weakness Pain in extremities Paresthesia Pelvic pain Pleural effusions Septic arthritis Synovitis Tremor Vomiting |
| Rare/Very Rare |
|---|
|
Alopecia Fever Granuloma annulare Lichenoid dermatitis drug eruption Menstrual disorder Urticaria |
The following precautions are available for IDACIO(CF) PEN (adalimumab-aacf):
Safety and efficacy of adalimumab for uses other than polyarticular juvenile idiopathic arthritis, Crohn disease, ulcerative colitis, and noninfectious uveitis have not been established in pediatric patients. Use of adalimumab for the management of hidradenitis suppurativa in adolescents is supported by clinical trials in adults. For marketing exclusivity reasons, adalimumab biosimilars are not labeled for use in pediatric patients with ulcerative colitis, hidradenitis suppurativa, or noninfectious uveitis.
Use of adalimumab for the management of polyarticular juvenile idiopathic arthritis in pediatric patients2 years of age or olderis supported by results of a safety and efficacy study in pediatric patients 4-17 years of age and additional data from a study in children 2 to <4 years of age indicating that the safety profile in this age group is similar to that in pediatric patients 4-17 years of age. In these studies, the types and frequencies of adverse effects generally were similar to those observed in adults. Safety and efficacy of adalimumab for the management of polyarticular juvenile idiopathic arthritis have not been established in pediatric patients less than 2 years of age or in those who weigh less than 10 kg.
Use of adalimumab for the management of Crohn disease in pediatric patients6 years of age or olderis supported by evidence from adequate and well-controlled studies in adults and additional data from a randomized, double-blind, 52-week clinical study of 2 dosage levels of the drug in 192 pediatric patients 6-17 years of age with moderately to severely active Crohn disease. Safety and efficacy for the management of Crohn disease have not been established in pediatric patients less than 6 years of age. Use of adalimumab for the management of ulcerative colitis in pediatric patients5 years of age or olderis supported by evidence from adequate and well-controlled studies in adults and additional data from a randomized, double-blind, 52-week clinical study of 2 dosage levels of the drug in 93 pediatric patients 5-17 years of age with moderately to severely active ulcerative colitis.
The recommended dosage of adalimumab in pediatric patients with ulcerative colitis is based on modeled dose/exposure-efficacy relationships and pharmacokinetic data; clinically relevant differences between the studied higher dosage administered in the clinical trial and the recommended dosage are not anticipated. Efficacy of adalimumab has not been established in patients who have lost response or were intolerant to TNF blocking agents. Safety and efficacy for the management of ulcerative colitis have not been established in pediatric patients less than 5 years of age.
Use of adalimumab for the management of noninfectious uveitis in pediatric patients2 years of age or olderis supported by evidence from adequate and well-controlled studies in adults and a randomized, controlled study in 90 pediatric patients. Safety and efficacy for the management of noninfectious uveitis have not been established in pediatric patients less than 2 years of age. Use of adalimumab for the management of hidradenitis suppurativa in pediatric patients12 years of age or olderis supported by evidence from adequate and well-controlled studies in adults.
The course of hidradenitis suppurativa in adults and adolescents is sufficiently similar to allow extrapolation of data from adults to adolescents. Population pharmacokinetic modeling and simulation data suggest that weight-based dosing in pediatric patients12 years of age or olderwill provide exposure levels that are generally similar to those achieved in adults. Safety and efficacy for the management of hidradenitis suppurativa have not been established in pediatric patients less than12 years of age.
When use of adalimumab is being considered for pediatric patients, review the vaccination status of the child and administer all age-appropriate vaccines included in current immunization guidelines. Malignancies, some fatal, have been reported in children and adolescents who received treatment with TNF blocking agents, including adalimumab. Neonates and infants who were exposed to adalimumab in utero may have impaired immune responses.
Data from 8 infants exposed to adalimumab in utero suggest that the drug crosses the placenta; the clinical importance of elevated adalimumab concentrations in infants is unknown. Consider the risks and benefits of administering live vaccines to infants who were exposed to adalimumab in utero, since the safety of live vaccines in these infants is unknown.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Use of adalimumab for the management of polyarticular juvenile idiopathic arthritis in pediatric patients2 years of age or olderis supported by results of a safety and efficacy study in pediatric patients 4-17 years of age and additional data from a study in children 2 to <4 years of age indicating that the safety profile in this age group is similar to that in pediatric patients 4-17 years of age. In these studies, the types and frequencies of adverse effects generally were similar to those observed in adults. Safety and efficacy of adalimumab for the management of polyarticular juvenile idiopathic arthritis have not been established in pediatric patients less than 2 years of age or in those who weigh less than 10 kg.
Use of adalimumab for the management of Crohn disease in pediatric patients6 years of age or olderis supported by evidence from adequate and well-controlled studies in adults and additional data from a randomized, double-blind, 52-week clinical study of 2 dosage levels of the drug in 192 pediatric patients 6-17 years of age with moderately to severely active Crohn disease. Safety and efficacy for the management of Crohn disease have not been established in pediatric patients less than 6 years of age. Use of adalimumab for the management of ulcerative colitis in pediatric patients5 years of age or olderis supported by evidence from adequate and well-controlled studies in adults and additional data from a randomized, double-blind, 52-week clinical study of 2 dosage levels of the drug in 93 pediatric patients 5-17 years of age with moderately to severely active ulcerative colitis.
The recommended dosage of adalimumab in pediatric patients with ulcerative colitis is based on modeled dose/exposure-efficacy relationships and pharmacokinetic data; clinically relevant differences between the studied higher dosage administered in the clinical trial and the recommended dosage are not anticipated. Efficacy of adalimumab has not been established in patients who have lost response or were intolerant to TNF blocking agents. Safety and efficacy for the management of ulcerative colitis have not been established in pediatric patients less than 5 years of age.
Use of adalimumab for the management of noninfectious uveitis in pediatric patients2 years of age or olderis supported by evidence from adequate and well-controlled studies in adults and a randomized, controlled study in 90 pediatric patients. Safety and efficacy for the management of noninfectious uveitis have not been established in pediatric patients less than 2 years of age. Use of adalimumab for the management of hidradenitis suppurativa in pediatric patients12 years of age or olderis supported by evidence from adequate and well-controlled studies in adults.
The course of hidradenitis suppurativa in adults and adolescents is sufficiently similar to allow extrapolation of data from adults to adolescents. Population pharmacokinetic modeling and simulation data suggest that weight-based dosing in pediatric patients12 years of age or olderwill provide exposure levels that are generally similar to those achieved in adults. Safety and efficacy for the management of hidradenitis suppurativa have not been established in pediatric patients less than12 years of age.
When use of adalimumab is being considered for pediatric patients, review the vaccination status of the child and administer all age-appropriate vaccines included in current immunization guidelines. Malignancies, some fatal, have been reported in children and adolescents who received treatment with TNF blocking agents, including adalimumab. Neonates and infants who were exposed to adalimumab in utero may have impaired immune responses.
Data from 8 infants exposed to adalimumab in utero suggest that the drug crosses the placenta; the clinical importance of elevated adalimumab concentrations in infants is unknown. Consider the risks and benefits of administering live vaccines to infants who were exposed to adalimumab in utero, since the safety of live vaccines in these infants is unknown.
Contraindicated
| None |
Severe Precaution
| Adalimumab | 1 Day – 2 Years | No safety and efficacy established age <2 years. Possible malignancy, lymphoma, hepatosplenic T-cell lymphoma risk. Risk of neutropenia, streptococcal pharyngitis, appendicitis, herpes zoster and simplex, myositis, and metrorrhagia. |
Management or Monitoring Precaution
| Adalimumab | 2 Years – 18 Years | Higher incidence of infection in pediatrics. Monitor for lymphoma, malignancy, leukemia, appendicitis and rare report of hepatosplenic T-cell lymphoma. |
Available studies of adalimumab use during pregnancy do not reliably establish an association between the drug and major birth defects. Results of a prospective, controlled, observational, pregnancy registry cohort study of pregnancy outcomes in adalimumab-treated females with rheumatoid arthritis or Crohn disease indicated that 10% of females in the adalimumab-exposed cohort (8.7% of those with rheumatoid arthritis, 10.5% of those with Crohn disease) delivered a live-born infant with a major birth defect, compared with 7.5% of females with rheumatoid arthritis or Crohn disease who had not been exposed to the drug (6.8% of those with rheumatoid arthritis, 9.4% of those with Crohn disease); however, no pattern of major birth defects was observed, and differences in the cohorts may have affected the observed occurrence rates.
All females in the adalimumab-exposed cohort were exposed to the drug for some period of time during the first trimester of pregnancy; 65% were exposed to the drug in all 3 trimesters. The study utilized data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby pregnancy registry from 2004-2016 and included data for 602 pregnant females, including 257 females with rheumatoid arthritis or Crohn disease who had been exposed to adalimumab during pregnancy, 120 disease-matched unexposed females, and 225 healthy unexposed females. Methodologic limitations of the registry study (e.g., small samplesize, voluntary nature of the study, nonrandomized design) preclude drawing definitive conclusions regarding the risk of major birth defects.
In an embryofetal-perinatal development study in cynomolgus monkeys, no fetal harm or malformations were observed at adalimumab exposure levels of up to approximately 373 times the exposure achieved at the maximum recommended human dosage (MRHD) for use without methotrexate. Data suggest that increased disease activity in females with rheumatoid arthritis or inflammatory bowel disease is associated with an increased risk of adverse pregnancy outcomes (e.g., preterm delivery, low birth weight, small size for gestational age at birth). As pregnancy progresses, monoclonal antibodies are increasingly transported across the placenta, with the largest amount transferred during the third trimester.
Adalimumab is actively transferred across the placenta during the third trimester of pregnancy. Results of a study in 10 pregnant females receiving adalimumab for treatment of inflammatory bowel disease (last dose administered 1-56 days prior to delivery) suggest that adalimumab may be detectable in the serum of infants exposed to the drug in utero for at least 3 months following birth. Adalimumab concentrations in cord blood were higher than maternal serum concentrations in 9 women in this study, and one infant had detectable serum concentrations of the drug measured through 11 weeks of age.
Adalimumab may affect immune response in infants exposed to the drug in utero. Consider the risks and benefits of administering live vaccines to such infants, since the safety of live vaccines in infants exposed to the drug in utero is unknown.
All females in the adalimumab-exposed cohort were exposed to the drug for some period of time during the first trimester of pregnancy; 65% were exposed to the drug in all 3 trimesters. The study utilized data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby pregnancy registry from 2004-2016 and included data for 602 pregnant females, including 257 females with rheumatoid arthritis or Crohn disease who had been exposed to adalimumab during pregnancy, 120 disease-matched unexposed females, and 225 healthy unexposed females. Methodologic limitations of the registry study (e.g., small samplesize, voluntary nature of the study, nonrandomized design) preclude drawing definitive conclusions regarding the risk of major birth defects.
In an embryofetal-perinatal development study in cynomolgus monkeys, no fetal harm or malformations were observed at adalimumab exposure levels of up to approximately 373 times the exposure achieved at the maximum recommended human dosage (MRHD) for use without methotrexate. Data suggest that increased disease activity in females with rheumatoid arthritis or inflammatory bowel disease is associated with an increased risk of adverse pregnancy outcomes (e.g., preterm delivery, low birth weight, small size for gestational age at birth). As pregnancy progresses, monoclonal antibodies are increasingly transported across the placenta, with the largest amount transferred during the third trimester.
Adalimumab is actively transferred across the placenta during the third trimester of pregnancy. Results of a study in 10 pregnant females receiving adalimumab for treatment of inflammatory bowel disease (last dose administered 1-56 days prior to delivery) suggest that adalimumab may be detectable in the serum of infants exposed to the drug in utero for at least 3 months following birth. Adalimumab concentrations in cord blood were higher than maternal serum concentrations in 9 women in this study, and one infant had detectable serum concentrations of the drug measured through 11 weeks of age.
Adalimumab may affect immune response in infants exposed to the drug in utero. Consider the risks and benefits of administering live vaccines to such infants, since the safety of live vaccines in infants exposed to the drug in utero is unknown.
| Drug/Drug Class | Severity | Precaution Description | Pregnancy Category Description |
|---|---|---|---|
| Adalimumab | 2 | Crosses placenta;Human and animal data have shown no known embryo/fetal toxicity | No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information. |
Limited data indicate that small amounts of adalimumab distribute into human milk (0.1-1% of maternal serum concentrations) and suggest that systemic exposure to adalimumab in nursing infants is likely to be low since the drug is a large molecule and is degraded in the GI tract. However, the effects of local exposure in the GI tract are unknown. There are no reports of adverse effects of adalimumab on breast-fed infants or effects of the drug on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for adalimumab and any potential adverse effects on the breast-fed child from the drug or underlying maternal condition.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Adalimumab | Excreted.This drug is known to be excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Limited data suggest low levels excreted; infant absorption unlikely |
No substantial differences in efficacy have been observed in geriatric patients with rheumatoid arthritis relative to younger adults. The incidence of serious infection and malignancy in adalimumab-treated patients greater than65 years of age is higher than the incidence in younger adults receiving the drug. Because the overall incidence of infection and malignancy is higher in the geriatric population in general than in younger adults, consider the risks and benefits of adalimumab in geriatric patients and closely monitor for the development of infection or malignancy if adalimumab is used.
Precaution Exists
Geriatric management or monitoring precaution exists.
Precaution Exists
Geriatric management or monitoring precaution exists.
| Drug Name | Narrative | REN | HEP | CARDIO | NEURO | PULM | ENDO |
|---|---|---|---|---|---|---|---|
| Adalimumab | General-Patients older than 65 years of age are at increased risk for severe infection and malignancy. | N | N | N | N | N | N |
The following prioritized warning is available for IDACIO(CF) PEN (adalimumab-aacf):
WARNING: This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). Tell your doctor your medical history, especially of past/recent/current infections.
You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. Tell your doctor right away if you develop signs of infection (see Side Effects section).
Your doctor will test you for tuberculosis (TB) infection before and during treatment with this drug. If you are diagnosed with TB, your doctor will first prescribe treatment for this to prevent a serious TB infection while using adalimumab. Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin cancer) due to this medication or due to your medical condition.
Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as a fever that doesn't go away, unusual lumps/growths, swollen glands, unexplained weight loss, or night sweats.
WARNING: This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). Tell your doctor your medical history, especially of past/recent/current infections.
You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. Tell your doctor right away if you develop signs of infection (see Side Effects section).
Your doctor will test you for tuberculosis (TB) infection before and during treatment with this drug. If you are diagnosed with TB, your doctor will first prescribe treatment for this to prevent a serious TB infection while using adalimumab. Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin cancer) due to this medication or due to your medical condition.
Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as a fever that doesn't go away, unusual lumps/growths, swollen glands, unexplained weight loss, or night sweats.
The following icd codes are available for IDACIO(CF) PEN (adalimumab-aacf)'s list of indications:
| Ankylosing spondylitis | |
| M08.1 | Juvenile ankylosing spondylitis |
| M45 | Ankylosing spondylitis |
| M45.0 | Ankylosing spondylitis of multiple sites in spine |
| M45.1 | Ankylosing spondylitis of occipito-atlanto-axial region |
| M45.2 | Ankylosing spondylitis of cervical region |
| M45.3 | Ankylosing spondylitis of cervicothoracic region |
| M45.4 | Ankylosing spondylitis of thoracic region |
| M45.5 | Ankylosing spondylitis of thoracolumbar region |
| M45.6 | Ankylosing spondylitis lumbar region |
| M45.7 | Ankylosing spondylitis of lumbosacral region |
| M45.8 | Ankylosing spondylitis sacral and sacrococcygeal region |
| M45.9 | Ankylosing spondylitis of unspecified sites in spine |
| Crohn's disease | |
| K50 | Crohn's disease [regional enteritis] |
| K50.0 | Crohn's disease of small intestine |
| K50.00 | Crohn's disease of small intestine without complications |
| K50.01 | Crohn's disease of small intestine with complications |
| K50.011 | Crohn's disease of small intestine with rectal bleeding |
| K50.012 | Crohn's disease of small intestine with intestinal obstruction |
| K50.013 | Crohn's disease of small intestine with fistula |
| K50.014 | Crohn's disease of small intestine with abscess |
| K50.018 | Crohn's disease of small intestine with other complication |
| K50.019 | Crohn's disease of small intestine with unspecified complications |
| K50.1 | Crohn's disease of large intestine |
| K50.10 | Crohn's disease of large intestine without complications |
| K50.11 | Crohn's disease of large intestine with complications |
| K50.111 | Crohn's disease of large intestine with rectal bleeding |
| K50.112 | Crohn's disease of large intestine with intestinal obstruction |
| K50.113 | Crohn's disease of large intestine with fistula |
| K50.114 | Crohn's disease of large intestine with abscess |
| K50.118 | Crohn's disease of large intestine with other complication |
| K50.119 | Crohn's disease of large intestine with unspecified complications |
| K50.8 | Crohn's disease of both small and large intestine |
| K50.80 | Crohn's disease of both small and large intestine without complications |
| K50.81 | Crohn's disease of both small and large intestine with complications |
| K50.811 | Crohn's disease of both small and large intestine with rectal bleeding |
| K50.812 | Crohn's disease of both small and large intestine with intestinal obstruction |
| K50.813 | Crohn's disease of both small and large intestine with fistula |
| K50.814 | Crohn's disease of both small and large intestine with abscess |
| K50.818 | Crohn's disease of both small and large intestine with other complication |
| K50.819 | Crohn's disease of both small and large intestine with unspecified complications |
| K50.9 | Crohn's disease, unspecified |
| K50.90 | Crohn's disease, unspecified, without complications |
| K50.91 | Crohn's disease, unspecified, with complications |
| K50.911 | Crohn's disease, unspecified, with rectal bleeding |
| K50.912 | Crohn's disease, unspecified, with intestinal obstruction |
| K50.913 | Crohn's disease, unspecified, with fistula |
| K50.914 | Crohn's disease, unspecified, with abscess |
| K50.918 | Crohn's disease, unspecified, with other complication |
| K50.919 | Crohn's disease, unspecified, with unspecified complications |
| Hidradenitis suppurativa | |
| L73.2 | Hidradenitis suppurativa |
| Moderate to severe plaque psoriasis | |
| L40.0 | Psoriasis vulgaris |
| L40.8 | Other psoriasis |
| L40.9 | Psoriasis, unspecified |
| Non-infectious uveitis | |
| D86.83 | Sarcoid iridocyclitis |
| H20.00 | Unspecified acute and subacute iridocyclitis |
| H20.04 | Secondary noninfectious iridocyclitis |
| H20.041 | Secondary noninfectious iridocyclitis, right eye |
| H20.042 | Secondary noninfectious iridocyclitis, left eye |
| H20.043 | Secondary noninfectious iridocyclitis, bilateral |
| H20.049 | Secondary noninfectious iridocyclitis, unspecified eye |
| H20.10 | Chronic iridocyclitis, unspecified eye |
| H20.82 | Vogt-koyanagi syndrome |
| H20.821 | Vogt-koyanagi syndrome, right eye |
| H20.822 | Vogt-koyanagi syndrome, left eye |
| H20.823 | Vogt-koyanagi syndrome, bilateral |
| H20.829 | Vogt-koyanagi syndrome, unspecified eye |
| H30.14 | Acute posterior multifocal placoid pigment epitheliopathy |
| H30.141 | Acute posterior multifocal placoid pigment epitheliopathy, right eye |
| H30.142 | Acute posterior multifocal placoid pigment epitheliopathy, left eye |
| H30.143 | Acute posterior multifocal placoid pigment epitheliopathy, bilateral |
| H30.149 | Acute posterior multifocal placoid pigment epitheliopathy, unspecified eye |
| H30.81 | Harada's disease |
| H30.811 | Harada's disease, right eye |
| H30.812 | Harada's disease, left eye |
| H30.813 | Harada's disease, bilateral |
| H30.819 | Harada's disease, unspecified eye |
| H44.11 | Panuveitis |
| H44.111 | Panuveitis, right eye |
| H44.112 | Panuveitis, left eye |
| H44.113 | Panuveitis, bilateral |
| H44.119 | Panuveitis, unspecified eye |
| H44.13 | Sympathetic uveitis |
| H44.131 | Sympathetic uveitis, right eye |
| H44.132 | Sympathetic uveitis, left eye |
| H44.133 | Sympathetic uveitis, bilateral |
| H44.139 | Sympathetic uveitis, unspecified eye |
| Polyarticular juvenile idiopathic arthritis | |
| M08.0 | Unspecified juvenile rheumatoid arthritis |
| M08.00 | Unspecified juvenile rheumatoid arthritis of unspecified site |
| M08.01 | Unspecified juvenile rheumatoid arthritis, shoulder |
| M08.011 | Unspecified juvenile rheumatoid arthritis, right shoulder |
| M08.012 | Unspecified juvenile rheumatoid arthritis, left shoulder |
| M08.019 | Unspecified juvenile rheumatoid arthritis, unspecified shoulder |
| M08.02 | Unspecified juvenile rheumatoid arthritis of elbow |
| M08.021 | Unspecified juvenile rheumatoid arthritis, right elbow |
| M08.022 | Unspecified juvenile rheumatoid arthritis, left elbow |
| M08.029 | Unspecified juvenile rheumatoid arthritis, unspecified elbow |
| M08.03 | Unspecified juvenile rheumatoid arthritis, wrist |
| M08.031 | Unspecified juvenile rheumatoid arthritis, right wrist |
| M08.032 | Unspecified juvenile rheumatoid arthritis, left wrist |
| M08.039 | Unspecified juvenile rheumatoid arthritis, unspecified wrist |
| M08.04 | Unspecified juvenile rheumatoid arthritis, hand |
| M08.041 | Unspecified juvenile rheumatoid arthritis, right hand |
| M08.042 | Unspecified juvenile rheumatoid arthritis, left hand |
| M08.049 | Unspecified juvenile rheumatoid arthritis, unspecified hand |
| M08.05 | Unspecified juvenile rheumatoid arthritis, hip |
| M08.051 | Unspecified juvenile rheumatoid arthritis, right hip |
| M08.052 | Unspecified juvenile rheumatoid arthritis, left hip |
| M08.059 | Unspecified juvenile rheumatoid arthritis, unspecified hip |
| M08.06 | Unspecified juvenile rheumatoid arthritis, knee |
| M08.061 | Unspecified juvenile rheumatoid arthritis, right knee |
| M08.062 | Unspecified juvenile rheumatoid arthritis, left knee |
| M08.069 | Unspecified juvenile rheumatoid arthritis, unspecified knee |
| M08.07 | Unspecified juvenile rheumatoid arthritis, ankle and foot |
| M08.071 | Unspecified juvenile rheumatoid arthritis, right ankle and foot |
| M08.072 | Unspecified juvenile rheumatoid arthritis, left ankle and foot |
| M08.079 | Unspecified juvenile rheumatoid arthritis, unspecified ankle and foot |
| M08.08 | Unspecified juvenile rheumatoid arthritis, vertebrae |
| M08.09 | Unspecified juvenile rheumatoid arthritis, multiple sites |
| M08.0A | Unspecified juvenile rheumatoid arthritis, other specified site |
| M08.2 | Juvenile rheumatoid arthritis with systemic onset |
| M08.20 | Juvenile rheumatoid arthritis with systemic onset, unspecified site |
| M08.21 | Juvenile rheumatoid arthritis with systemic onset, shoulder |
| M08.211 | Juvenile rheumatoid arthritis with systemic onset, right shoulder |
| M08.212 | Juvenile rheumatoid arthritis with systemic onset, left shoulder |
| M08.219 | Juvenile rheumatoid arthritis with systemic onset, unspecified shoulder |
| M08.22 | Juvenile rheumatoid arthritis with systemic onset, elbow |
| M08.221 | Juvenile rheumatoid arthritis with systemic onset, right elbow |
| M08.222 | Juvenile rheumatoid arthritis with systemic onset, left elbow |
| M08.229 | Juvenile rheumatoid arthritis with systemic onset, unspecified elbow |
| M08.23 | Juvenile rheumatoid arthritis with systemic onset, wrist |
| M08.231 | Juvenile rheumatoid arthritis with systemic onset, right wrist |
| M08.232 | Juvenile rheumatoid arthritis with systemic onset, left wrist |
| M08.239 | Juvenile rheumatoid arthritis with systemic onset, unspecified wrist |
| M08.24 | Juvenile rheumatoid arthritis with systemic onset, hand |
| M08.241 | Juvenile rheumatoid arthritis with systemic onset, right hand |
| M08.242 | Juvenile rheumatoid arthritis with systemic onset, left hand |
| M08.249 | Juvenile rheumatoid arthritis with systemic onset, unspecified hand |
| M08.25 | Juvenile rheumatoid arthritis with systemic onset, hip |
| M08.251 | Juvenile rheumatoid arthritis with systemic onset, right hip |
| M08.252 | Juvenile rheumatoid arthritis with systemic onset, left hip |
| M08.259 | Juvenile rheumatoid arthritis with systemic onset, unspecified hip |
| M08.26 | Juvenile rheumatoid arthritis with systemic onset, knee |
| M08.261 | Juvenile rheumatoid arthritis with systemic onset, right knee |
| M08.262 | Juvenile rheumatoid arthritis with systemic onset, left knee |
| M08.269 | Juvenile rheumatoid arthritis with systemic onset, unspecified knee |
| M08.27 | Juvenile rheumatoid arthritis with systemic onset, ankle and foot |
| M08.271 | Juvenile rheumatoid arthritis with systemic onset, right ankle and foot |
| M08.272 | Juvenile rheumatoid arthritis with systemic onset, left ankle and foot |
| M08.279 | Juvenile rheumatoid arthritis with systemic onset, unspecified ankle and foot |
| M08.28 | Juvenile rheumatoid arthritis with systemic onset, vertebrae |
| M08.29 | Juvenile rheumatoid arthritis with systemic onset, multiple sites |
| M08.2A | Juvenile rheumatoid arthritis with systemic onset, other specified site |
| M08.3 | Juvenile rheumatoid polyarthritis (seronegative) |
| M08.4 | Pauciarticular juvenile rheumatoid arthritis |
| M08.40 | Pauciarticular juvenile rheumatoid arthritis, unspecified site |
| M08.41 | Pauciarticular juvenile rheumatoid arthritis, shoulder |
| M08.411 | Pauciarticular juvenile rheumatoid arthritis, right shoulder |
| M08.412 | Pauciarticular juvenile rheumatoid arthritis, left shoulder |
| M08.419 | Pauciarticular juvenile rheumatoid arthritis, unspecified shoulder |
| M08.42 | Pauciarticular juvenile rheumatoid arthritis, elbow |
| M08.421 | Pauciarticular juvenile rheumatoid arthritis, right elbow |
| M08.422 | Pauciarticular juvenile rheumatoid arthritis, left elbow |
| M08.429 | Pauciarticular juvenile rheumatoid arthritis, unspecified elbow |
| M08.43 | Pauciarticular juvenile rheumatoid arthritis, wrist |
| M08.431 | Pauciarticular juvenile rheumatoid arthritis, right wrist |
| M08.432 | Pauciarticular juvenile rheumatoid arthritis, left wrist |
| M08.439 | Pauciarticular juvenile rheumatoid arthritis, unspecified wrist |
| M08.44 | Pauciarticular juvenile rheumatoid arthritis, hand |
| M08.441 | Pauciarticular juvenile rheumatoid arthritis, right hand |
| M08.442 | Pauciarticular juvenile rheumatoid arthritis, left hand |
| M08.449 | Pauciarticular juvenile rheumatoid arthritis, unspecified hand |
| M08.45 | Pauciarticular juvenile rheumatoid arthritis, hip |
| M08.451 | Pauciarticular juvenile rheumatoid arthritis, right hip |
| M08.452 | Pauciarticular juvenile rheumatoid arthritis, left hip |
| M08.459 | Pauciarticular juvenile rheumatoid arthritis, unspecified hip |
| M08.46 | Pauciarticular juvenile rheumatoid arthritis, knee |
| M08.461 | Pauciarticular juvenile rheumatoid arthritis, right knee |
| M08.462 | Pauciarticular juvenile rheumatoid arthritis, left knee |
| M08.469 | Pauciarticular juvenile rheumatoid arthritis, unspecified knee |
| M08.47 | Pauciarticular juvenile rheumatoid arthritis, ankle and foot |
| M08.471 | Pauciarticular juvenile rheumatoid arthritis, right ankle and foot |
| M08.472 | Pauciarticular juvenile rheumatoid arthritis, left ankle and foot |
| M08.479 | Pauciarticular juvenile rheumatoid arthritis, unspecified ankle and foot |
| M08.48 | Pauciarticular juvenile rheumatoid arthritis, vertebrae |
| M08.4A | Pauciarticular juvenile rheumatoid arthritis, other specified site |
| Psoriatic arthritis | |
| L40.5 | Arthropathic psoriasis |
| L40.50 | Arthropathic psoriasis, unspecified |
| L40.51 | Distal interphalangeal psoriatic arthropathy |
| L40.52 | Psoriatic arthritis mutilans |
| L40.53 | Psoriatic spondylitis |
| L40.54 | Psoriatic juvenile arthropathy |
| L40.59 | Other psoriatic arthropathy |
| Rheumatoid arthritis | |
| M05 | Rheumatoid arthritis with rheumatoid factor |
| M05.0 | Felty's syndrome |
| M05.00 | Felty's syndrome, unspecified site |
| M05.01 | Felty's syndrome, shoulder |
| M05.011 | Felty's syndrome, right shoulder |
| M05.012 | Felty's syndrome, left shoulder |
| M05.019 | Felty's syndrome, unspecified shoulder |
| M05.02 | Felty's syndrome, elbow |
| M05.021 | Felty's syndrome, right elbow |
| M05.022 | Felty's syndrome, left elbow |
| M05.029 | Felty's syndrome, unspecified elbow |
| M05.03 | Felty's syndrome, wrist |
| M05.031 | Felty's syndrome, right wrist |
| M05.032 | Felty's syndrome, left wrist |
| M05.039 | Felty's syndrome, unspecified wrist |
| M05.04 | Felty's syndrome, hand |
| M05.041 | Felty's syndrome, right hand |
| M05.042 | Felty's syndrome, left hand |
| M05.049 | Felty's syndrome, unspecified hand |
| M05.05 | Felty's syndrome, hip |
| M05.051 | Felty's syndrome, right hip |
| M05.052 | Felty's syndrome, left hip |
| M05.059 | Felty's syndrome, unspecified hip |
| M05.06 | Felty's syndrome, knee |
| M05.061 | Felty's syndrome, right knee |
| M05.062 | Felty's syndrome, left knee |
| M05.069 | Felty's syndrome, unspecified knee |
| M05.07 | Felty's syndrome, ankle and foot |
| M05.071 | Felty's syndrome, right ankle and foot |
| M05.072 | Felty's syndrome, left ankle and foot |
| M05.079 | Felty's syndrome, unspecified ankle and foot |
| M05.09 | Felty's syndrome, multiple sites |
| M05.1 | Rheumatoid lung disease with rheumatoid arthritis |
| M05.10 | Rheumatoid lung disease with rheumatoid arthritis of unspecified site |
| M05.11 | Rheumatoid lung disease with rheumatoid arthritis of shoulder |
| M05.111 | Rheumatoid lung disease with rheumatoid arthritis of right shoulder |
| M05.112 | Rheumatoid lung disease with rheumatoid arthritis of left shoulder |
| M05.119 | Rheumatoid lung disease with rheumatoid arthritis of unspecified shoulder |
| M05.12 | Rheumatoid lung disease with rheumatoid arthritis of elbow |
| M05.121 | Rheumatoid lung disease with rheumatoid arthritis of right elbow |
| M05.122 | Rheumatoid lung disease with rheumatoid arthritis of left elbow |
| M05.129 | Rheumatoid lung disease with rheumatoid arthritis of unspecified elbow |
| M05.13 | Rheumatoid lung disease with rheumatoid arthritis of wrist |
| M05.131 | Rheumatoid lung disease with rheumatoid arthritis of right wrist |
| M05.132 | Rheumatoid lung disease with rheumatoid arthritis of left wrist |
| M05.139 | Rheumatoid lung disease with rheumatoid arthritis of unspecified wrist |
| M05.14 | Rheumatoid lung disease with rheumatoid arthritis of hand |
| M05.141 | Rheumatoid lung disease with rheumatoid arthritis of right hand |
| M05.142 | Rheumatoid lung disease with rheumatoid arthritis of left hand |
| M05.149 | Rheumatoid lung disease with rheumatoid arthritis of unspecified hand |
| M05.15 | Rheumatoid lung disease with rheumatoid arthritis of hip |
| M05.151 | Rheumatoid lung disease with rheumatoid arthritis of right hip |
| M05.152 | Rheumatoid lung disease with rheumatoid arthritis of left hip |
| M05.159 | Rheumatoid lung disease with rheumatoid arthritis of unspecified hip |
| M05.16 | Rheumatoid lung disease with rheumatoid arthritis of knee |
| M05.161 | Rheumatoid lung disease with rheumatoid arthritis of right knee |
| M05.162 | Rheumatoid lung disease with rheumatoid arthritis of left knee |
| M05.169 | Rheumatoid lung disease with rheumatoid arthritis of unspecified knee |
| M05.17 | Rheumatoid lung disease with rheumatoid arthritis of ankle and foot |
| M05.171 | Rheumatoid lung disease with rheumatoid arthritis of right ankle and foot |
| M05.172 | Rheumatoid lung disease with rheumatoid arthritis of left ankle and foot |
| M05.179 | Rheumatoid lung disease with rheumatoid arthritis of unspecified ankle and foot |
| M05.19 | Rheumatoid lung disease with rheumatoid arthritis of multiple sites |
| M05.2 | Rheumatoid vasculitis with rheumatoid arthritis |
| M05.20 | Rheumatoid vasculitis with rheumatoid arthritis of unspecified site |
| M05.21 | Rheumatoid vasculitis with rheumatoid arthritis of shoulder |
| M05.211 | Rheumatoid vasculitis with rheumatoid arthritis of right shoulder |
| M05.212 | Rheumatoid vasculitis with rheumatoid arthritis of left shoulder |
| M05.219 | Rheumatoid vasculitis with rheumatoid arthritis of unspecified shoulder |
| M05.22 | Rheumatoid vasculitis with rheumatoid arthritis of elbow |
| M05.221 | Rheumatoid vasculitis with rheumatoid arthritis of right elbow |
| M05.222 | Rheumatoid vasculitis with rheumatoid arthritis of left elbow |
| M05.229 | Rheumatoid vasculitis with rheumatoid arthritis of unspecified elbow |
| M05.23 | Rheumatoid vasculitis with rheumatoid arthritis of wrist |
| M05.231 | Rheumatoid vasculitis with rheumatoid arthritis of right wrist |
| M05.232 | Rheumatoid vasculitis with rheumatoid arthritis of left wrist |
| M05.239 | Rheumatoid vasculitis with rheumatoid arthritis of unspecified wrist |
| M05.24 | Rheumatoid vasculitis with rheumatoid arthritis of hand |
| M05.241 | Rheumatoid vasculitis with rheumatoid arthritis of right hand |
| M05.242 | Rheumatoid vasculitis with rheumatoid arthritis of left hand |
| M05.249 | Rheumatoid vasculitis with rheumatoid arthritis of unspecified hand |
| M05.25 | Rheumatoid vasculitis with rheumatoid arthritis of hip |
| M05.251 | Rheumatoid vasculitis with rheumatoid arthritis of right hip |
| M05.252 | Rheumatoid vasculitis with rheumatoid arthritis of left hip |
| M05.259 | Rheumatoid vasculitis with rheumatoid arthritis of unspecified hip |
| M05.26 | Rheumatoid vasculitis with rheumatoid arthritis of knee |
| M05.261 | Rheumatoid vasculitis with rheumatoid arthritis of right knee |
| M05.262 | Rheumatoid vasculitis with rheumatoid arthritis of left knee |
| M05.269 | Rheumatoid vasculitis with rheumatoid arthritis of unspecified knee |
| M05.27 | Rheumatoid vasculitis with rheumatoid arthritis of ankle and foot |
| M05.271 | Rheumatoid vasculitis with rheumatoid arthritis of right ankle and foot |
| M05.272 | Rheumatoid vasculitis with rheumatoid arthritis of left ankle and foot |
| M05.279 | Rheumatoid vasculitis with rheumatoid arthritis of unspecified ankle and foot |
| M05.29 | Rheumatoid vasculitis with rheumatoid arthritis of multiple sites |
| M05.3 | Rheumatoid heart disease with rheumatoid arthritis |
| M05.30 | Rheumatoid heart disease with rheumatoid arthritis of unspecified site |
| M05.31 | Rheumatoid heart disease with rheumatoid arthritis of shoulder |
| M05.311 | Rheumatoid heart disease with rheumatoid arthritis of right shoulder |
| M05.312 | Rheumatoid heart disease with rheumatoid arthritis of left shoulder |
| M05.319 | Rheumatoid heart disease with rheumatoid arthritis of unspecified shoulder |
| M05.32 | Rheumatoid heart disease with rheumatoid arthritis of elbow |
| M05.321 | Rheumatoid heart disease with rheumatoid arthritis of right elbow |
| M05.322 | Rheumatoid heart disease with rheumatoid arthritis of left elbow |
| M05.329 | Rheumatoid heart disease with rheumatoid arthritis of unspecified elbow |
| M05.33 | Rheumatoid heart disease with rheumatoid arthritis of wrist |
| M05.331 | Rheumatoid heart disease with rheumatoid arthritis of right wrist |
| M05.332 | Rheumatoid heart disease with rheumatoid arthritis of left wrist |
| M05.339 | Rheumatoid heart disease with rheumatoid arthritis of unspecified wrist |
| M05.34 | Rheumatoid heart disease with rheumatoid arthritis of hand |
| M05.341 | Rheumatoid heart disease with rheumatoid arthritis of right hand |
| M05.342 | Rheumatoid heart disease with rheumatoid arthritis of left hand |
| M05.349 | Rheumatoid heart disease with rheumatoid arthritis of unspecified hand |
| M05.35 | Rheumatoid heart disease with rheumatoid arthritis of hip |
| M05.351 | Rheumatoid heart disease with rheumatoid arthritis of right hip |
| M05.352 | Rheumatoid heart disease with rheumatoid arthritis of left hip |
| M05.359 | Rheumatoid heart disease with rheumatoid arthritis of unspecified hip |
| M05.36 | Rheumatoid heart disease with rheumatoid arthritis of knee |
| M05.361 | Rheumatoid heart disease with rheumatoid arthritis of right knee |
| M05.362 | Rheumatoid heart disease with rheumatoid arthritis of left knee |
| M05.369 | Rheumatoid heart disease with rheumatoid arthritis of unspecified knee |
| M05.37 | Rheumatoid heart disease with rheumatoid arthritis of ankle and foot |
| M05.371 | Rheumatoid heart disease with rheumatoid arthritis of right ankle and foot |
| M05.372 | Rheumatoid heart disease with rheumatoid arthritis of left ankle and foot |
| M05.379 | Rheumatoid heart disease with rheumatoid arthritis of unspecified ankle and foot |
| M05.39 | Rheumatoid heart disease with rheumatoid arthritis of multiple sites |
| M05.4 | Rheumatoid myopathy with rheumatoid arthritis |
| M05.40 | Rheumatoid myopathy with rheumatoid arthritis of unspecified site |
| M05.41 | Rheumatoid myopathy with rheumatoid arthritis of shoulder |
| M05.411 | Rheumatoid myopathy with rheumatoid arthritis of right shoulder |
| M05.412 | Rheumatoid myopathy with rheumatoid arthritis of left shoulder |
| M05.419 | Rheumatoid myopathy with rheumatoid arthritis of unspecified shoulder |
| M05.42 | Rheumatoid myopathy with rheumatoid arthritis of elbow |
| M05.421 | Rheumatoid myopathy with rheumatoid arthritis of right elbow |
| M05.422 | Rheumatoid myopathy with rheumatoid arthritis of left elbow |
| M05.429 | Rheumatoid myopathy with rheumatoid arthritis of unspecified elbow |
| M05.43 | Rheumatoid myopathy with rheumatoid arthritis of wrist |
| M05.431 | Rheumatoid myopathy with rheumatoid arthritis of right wrist |
| M05.432 | Rheumatoid myopathy with rheumatoid arthritis of left wrist |
| M05.439 | Rheumatoid myopathy with rheumatoid arthritis of unspecified wrist |
| M05.44 | Rheumatoid myopathy with rheumatoid arthritis of hand |
| M05.441 | Rheumatoid myopathy with rheumatoid arthritis of right hand |
| M05.442 | Rheumatoid myopathy with rheumatoid arthritis of left hand |
| M05.449 | Rheumatoid myopathy with rheumatoid arthritis of unspecified hand |
| M05.45 | Rheumatoid myopathy with rheumatoid arthritis of hip |
| M05.451 | Rheumatoid myopathy with rheumatoid arthritis of right hip |
| M05.452 | Rheumatoid myopathy with rheumatoid arthritis of left hip |
| M05.459 | Rheumatoid myopathy with rheumatoid arthritis of unspecified hip |
| M05.46 | Rheumatoid myopathy with rheumatoid arthritis of knee |
| M05.461 | Rheumatoid myopathy with rheumatoid arthritis of right knee |
| M05.462 | Rheumatoid myopathy with rheumatoid arthritis of left knee |
| M05.469 | Rheumatoid myopathy with rheumatoid arthritis of unspecified knee |
| M05.47 | Rheumatoid myopathy with rheumatoid arthritis of ankle and foot |
| M05.471 | Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot |
| M05.472 | Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot |
| M05.479 | Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot |
| M05.49 | Rheumatoid myopathy with rheumatoid arthritis of multiple sites |
| M05.5 | Rheumatoid polyneuropathy with rheumatoid arthritis |
| M05.50 | Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified site |
| M05.51 | Rheumatoid polyneuropathy with rheumatoid arthritis of shoulder |
| M05.511 | Rheumatoid polyneuropathy with rheumatoid arthritis of right shoulder |
| M05.512 | Rheumatoid polyneuropathy with rheumatoid arthritis of left shoulder |
| M05.519 | Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified shoulder |
| M05.52 | Rheumatoid polyneuropathy with rheumatoid arthritis of elbow |
| M05.521 | Rheumatoid polyneuropathy with rheumatoid arthritis of right elbow |
| M05.522 | Rheumatoid polyneuropathy with rheumatoid arthritis of left elbow |
| M05.529 | Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified elbow |
| M05.53 | Rheumatoid polyneuropathy with rheumatoid arthritis of wrist |
| M05.531 | Rheumatoid polyneuropathy with rheumatoid arthritis of right wrist |
| M05.532 | Rheumatoid polyneuropathy with rheumatoid arthritis of left wrist |
| M05.539 | Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified wrist |
| M05.54 | Rheumatoid polyneuropathy with rheumatoid arthritis of hand |
| M05.541 | Rheumatoid polyneuropathy with rheumatoid arthritis of right hand |
| M05.542 | Rheumatoid polyneuropathy with rheumatoid arthritis of left hand |
| M05.549 | Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hand |
| M05.55 | Rheumatoid polyneuropathy with rheumatoid arthritis of hip |
| M05.551 | Rheumatoid polyneuropathy with rheumatoid arthritis of right hip |
| M05.552 | Rheumatoid polyneuropathy with rheumatoid arthritis of left hip |
| M05.559 | Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hip |
| M05.56 | Rheumatoid polyneuropathy with rheumatoid arthritis of knee |
| M05.561 | Rheumatoid polyneuropathy with rheumatoid arthritis of right knee |
| M05.562 | Rheumatoid polyneuropathy with rheumatoid arthritis of left knee |
| M05.569 | Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified knee |
| M05.57 | Rheumatoid polyneuropathy with rheumatoid arthritis of ankle and foot |
| M05.571 | Rheumatoid polyneuropathy with rheumatoid arthritis of right ankle and foot |
| M05.572 | Rheumatoid polyneuropathy with rheumatoid arthritis of left ankle and foot |
| M05.579 | Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified ankle and foot |
| M05.59 | Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites |
| M05.6 | Rheumatoid arthritis with involvement of other organs and systems |
| M05.60 | Rheumatoid arthritis of unspecified site with involvement of other organs and systems |
| M05.61 | Rheumatoid arthritis of shoulder with involvement of other organs and systems |
| M05.611 | Rheumatoid arthritis of right shoulder with involvement of other organs and systems |
| M05.612 | Rheumatoid arthritis of left shoulder with involvement of other organs and systems |
| M05.619 | Rheumatoid arthritis of unspecified shoulder with involvement of other organs and systems |
| M05.62 | Rheumatoid arthritis of elbow with involvement of other organs and systems |
| M05.621 | Rheumatoid arthritis of right elbow with involvement of other organs and systems |
| M05.622 | Rheumatoid arthritis of left elbow with involvement of other organs and systems |
| M05.629 | Rheumatoid arthritis of unspecified elbow with involvement of other organs and systems |
| M05.63 | Rheumatoid arthritis of wrist with involvement of other organs and systems |
| M05.631 | Rheumatoid arthritis of right wrist with involvement of other organs and systems |
| M05.632 | Rheumatoid arthritis of left wrist with involvement of other organs and systems |
| M05.639 | Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems |
| M05.64 | Rheumatoid arthritis of hand with involvement of other organs and systems |
| M05.641 | Rheumatoid arthritis of right hand with involvement of other organs and systems |
| M05.642 | Rheumatoid arthritis of left hand with involvement of other organs and systems |
| M05.649 | Rheumatoid arthritis of unspecified hand with involvement of other organs and systems |
| M05.65 | Rheumatoid arthritis of hip with involvement of other organs and systems |
| M05.651 | Rheumatoid arthritis of right hip with involvement of other organs and systems |
| M05.652 | Rheumatoid arthritis of left hip with involvement of other organs and systems |
| M05.659 | Rheumatoid arthritis of unspecified hip with involvement of other organs and systems |
| M05.66 | Rheumatoid arthritis of knee with involvement of other organs and systems |
| M05.661 | Rheumatoid arthritis of right knee with involvement of other organs and systems |
| M05.662 | Rheumatoid arthritis of left knee with involvement of other organs and systems |
| M05.669 | Rheumatoid arthritis of unspecified knee with involvement of other organs and systems |
| M05.67 | Rheumatoid arthritis of ankle and foot with involvement of other organs and systems |
| M05.671 | Rheumatoid arthritis of right ankle and foot with involvement of other organs and systems |
| M05.672 | Rheumatoid arthritis of left ankle and foot with involvement of other organs and systems |
| M05.679 | Rheumatoid arthritis of unspecified ankle and foot with involvement of other organs and systems |
| M05.69 | Rheumatoid arthritis of multiple sites with involvement of other organs and systems |
| M05.7 | Rheumatoid arthritis with rheumatoid factor without organ or systems involvement |
| M05.70 | Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems involvement |
| M05.71 | Rheumatoid arthritis with rheumatoid factor of shoulder without organ or systems involvement |
| M05.711 | Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems involvement |
| M05.712 | Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems involvement |
| M05.719 | Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems involvement |
| M05.72 | Rheumatoid arthritis with rheumatoid factor of elbow without organ or systems involvement |
| M05.721 | Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems involvement |
| M05.722 | Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems involvement |
| M05.729 | Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems involvement |
| M05.73 | Rheumatoid arthritis with rheumatoid factor of wrist without organ or systems involvement |
| M05.731 | Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems involvement |
| M05.732 | Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems involvement |
| M05.739 | Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems involvement |
| M05.74 | Rheumatoid arthritis with rheumatoid factor of hand without organ or systems involvement |
| M05.741 | Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement |
| M05.742 | Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems involvement |
| M05.749 | Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems involvement |
| M05.75 | Rheumatoid arthritis with rheumatoid factor of hip without organ or systems involvement |
| M05.751 | Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems involvement |
| M05.752 | Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement |
| M05.759 | Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement |
| M05.76 | Rheumatoid arthritis with rheumatoid factor of knee without organ or systems involvement |
| M05.761 | Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement |
| M05.762 | Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement |
| M05.769 | Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement |
| M05.77 | Rheumatoid arthritis with rheumatoid factor of ankle and foot without organ or systems involvement |
| M05.771 | Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement |
| M05.772 | Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement |
| M05.779 | Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement |
| M05.79 | Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement |
| M05.7A | Rheumatoid arthritis with rheumatoid factor of other specified site without organ or systems involvement |
| M05.8 | Other rheumatoid arthritis with rheumatoid factor |
| M05.80 | Other rheumatoid arthritis with rheumatoid factor of unspecified site |
| M05.81 | Other rheumatoid arthritis with rheumatoid factor of shoulder |
| M05.811 | Other rheumatoid arthritis with rheumatoid factor of right shoulder |
| M05.812 | Other rheumatoid arthritis with rheumatoid factor of left shoulder |
| M05.819 | Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder |
| M05.82 | Other rheumatoid arthritis with rheumatoid factor of elbow |
| M05.821 | Other rheumatoid arthritis with rheumatoid factor of right elbow |
| M05.822 | Other rheumatoid arthritis with rheumatoid factor of left elbow |
| M05.829 | Other rheumatoid arthritis with rheumatoid factor of unspecified elbow |
| M05.83 | Other rheumatoid arthritis with rheumatoid factor of wrist |
| M05.831 | Other rheumatoid arthritis with rheumatoid factor of right wrist |
| M05.832 | Other rheumatoid arthritis with rheumatoid factor of left wrist |
| M05.839 | Other rheumatoid arthritis with rheumatoid factor of unspecified wrist |
| M05.84 | Other rheumatoid arthritis with rheumatoid factor of hand |
| M05.841 | Other rheumatoid arthritis with rheumatoid factor of right hand |
| M05.842 | Other rheumatoid arthritis with rheumatoid factor of left hand |
| M05.849 | Other rheumatoid arthritis with rheumatoid factor of unspecified hand |
| M05.85 | Other rheumatoid arthritis with rheumatoid factor of hip |
| M05.851 | Other rheumatoid arthritis with rheumatoid factor of right hip |
| M05.852 | Other rheumatoid arthritis with rheumatoid factor of left hip |
| M05.859 | Other rheumatoid arthritis with rheumatoid factor of unspecified hip |
| M05.86 | Other rheumatoid arthritis with rheumatoid factor of knee |
| M05.861 | Other rheumatoid arthritis with rheumatoid factor of right knee |
| M05.862 | Other rheumatoid arthritis with rheumatoid factor of left knee |
| M05.869 | Other rheumatoid arthritis with rheumatoid factor of unspecified knee |
| M05.87 | Other rheumatoid arthritis with rheumatoid factor of ankle and foot |
| M05.871 | Other rheumatoid arthritis with rheumatoid factor of right ankle and foot |
| M05.872 | Other rheumatoid arthritis with rheumatoid factor of left ankle and foot |
| M05.879 | Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot |
| M05.89 | Other rheumatoid arthritis with rheumatoid factor of multiple sites |
| M05.8A | Other rheumatoid arthritis with rheumatoid factor of other specified site |
| M05.9 | Rheumatoid arthritis with rheumatoid factor, unspecified |
| M06 | Other rheumatoid arthritis |
| M06.0 | Rheumatoid arthritis without rheumatoid factor |
| M06.00 | Rheumatoid arthritis without rheumatoid factor, unspecified site |
| M06.01 | Rheumatoid arthritis without rheumatoid factor, shoulder |
| M06.011 | Rheumatoid arthritis without rheumatoid factor, right shoulder |
| M06.012 | Rheumatoid arthritis without rheumatoid factor, left shoulder |
| M06.019 | Rheumatoid arthritis without rheumatoid factor, unspecified shoulder |
| M06.02 | Rheumatoid arthritis without rheumatoid factor, elbow |
| M06.021 | Rheumatoid arthritis without rheumatoid factor, right elbow |
| M06.022 | Rheumatoid arthritis without rheumatoid factor, left elbow |
| M06.029 | Rheumatoid arthritis without rheumatoid factor, unspecified elbow |
| M06.03 | Rheumatoid arthritis without rheumatoid factor, wrist |
| M06.031 | Rheumatoid arthritis without rheumatoid factor, right wrist |
| M06.032 | Rheumatoid arthritis without rheumatoid factor, left wrist |
| M06.039 | Rheumatoid arthritis without rheumatoid factor, unspecified wrist |
| M06.04 | Rheumatoid arthritis without rheumatoid factor, hand |
| M06.041 | Rheumatoid arthritis without rheumatoid factor, right hand |
| M06.042 | Rheumatoid arthritis without rheumatoid factor, left hand |
| M06.049 | Rheumatoid arthritis without rheumatoid factor, unspecified hand |
| M06.05 | Rheumatoid arthritis without rheumatoid factor, hip |
| M06.051 | Rheumatoid arthritis without rheumatoid factor, right hip |
| M06.052 | Rheumatoid arthritis without rheumatoid factor, left hip |
| M06.059 | Rheumatoid arthritis without rheumatoid factor, unspecified hip |
| M06.06 | Rheumatoid arthritis without rheumatoid factor, knee |
| M06.061 | Rheumatoid arthritis without rheumatoid factor, right knee |
| M06.062 | Rheumatoid arthritis without rheumatoid factor, left knee |
| M06.069 | Rheumatoid arthritis without rheumatoid factor, unspecified knee |
| M06.07 | Rheumatoid arthritis without rheumatoid factor, ankle and foot |
| M06.071 | Rheumatoid arthritis without rheumatoid factor, right ankle and foot |
| M06.072 | Rheumatoid arthritis without rheumatoid factor, left ankle and foot |
| M06.079 | Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot |
| M06.08 | Rheumatoid arthritis without rheumatoid factor, vertebrae |
| M06.09 | Rheumatoid arthritis without rheumatoid factor, multiple sites |
| M06.0A | Rheumatoid arthritis without rheumatoid factor, other specified site |
| M06.8 | Other specified rheumatoid arthritis |
| M06.80 | Other specified rheumatoid arthritis, unspecified site |
| M06.81 | Other specified rheumatoid arthritis, shoulder |
| M06.811 | Other specified rheumatoid arthritis, right shoulder |
| M06.812 | Other specified rheumatoid arthritis, left shoulder |
| M06.819 | Other specified rheumatoid arthritis, unspecified shoulder |
| M06.82 | Other specified rheumatoid arthritis, elbow |
| M06.821 | Other specified rheumatoid arthritis, right elbow |
| M06.822 | Other specified rheumatoid arthritis, left elbow |
| M06.829 | Other specified rheumatoid arthritis, unspecified elbow |
| M06.83 | Other specified rheumatoid arthritis, wrist |
| M06.831 | Other specified rheumatoid arthritis, right wrist |
| M06.832 | Other specified rheumatoid arthritis, left wrist |
| M06.839 | Other specified rheumatoid arthritis, unspecified wrist |
| M06.84 | Other specified rheumatoid arthritis, hand |
| M06.841 | Other specified rheumatoid arthritis, right hand |
| M06.842 | Other specified rheumatoid arthritis, left hand |
| M06.849 | Other specified rheumatoid arthritis, unspecified hand |
| M06.85 | Other specified rheumatoid arthritis, hip |
| M06.851 | Other specified rheumatoid arthritis, right hip |
| M06.852 | Other specified rheumatoid arthritis, left hip |
| M06.859 | Other specified rheumatoid arthritis, unspecified hip |
| M06.86 | Other specified rheumatoid arthritis, knee |
| M06.861 | Other specified rheumatoid arthritis, right knee |
| M06.862 | Other specified rheumatoid arthritis, left knee |
| M06.869 | Other specified rheumatoid arthritis, unspecified knee |
| M06.87 | Other specified rheumatoid arthritis, ankle and foot |
| M06.871 | Other specified rheumatoid arthritis, right ankle and foot |
| M06.872 | Other specified rheumatoid arthritis, left ankle and foot |
| M06.879 | Other specified rheumatoid arthritis, unspecified ankle and foot |
| M06.88 | Other specified rheumatoid arthritis, vertebrae |
| M06.89 | Other specified rheumatoid arthritis, multiple sites |
| M06.8A | Other specified rheumatoid arthritis, other specified site |
| M06.9 | Rheumatoid arthritis, unspecified |
| Ulcerative colitis | |
| K51 | Ulcerative colitis |
| K51.0 | Ulcerative (chronic) pancolitis |
| K51.00 | Ulcerative (chronic) pancolitis without complications |
| K51.01 | Ulcerative (chronic) pancolitis with complications |
| K51.011 | Ulcerative (chronic) pancolitis with rectal bleeding |
| K51.012 | Ulcerative (chronic) pancolitis with intestinal obstruction |
| K51.013 | Ulcerative (chronic) pancolitis with fistula |
| K51.014 | Ulcerative (chronic) pancolitis with abscess |
| K51.018 | Ulcerative (chronic) pancolitis with other complication |
| K51.019 | Ulcerative (chronic) pancolitis with unspecified complications |
| K51.2 | Ulcerative (chronic) proctitis |
| K51.20 | Ulcerative (chronic) proctitis without complications |
| K51.21 | Ulcerative (chronic) proctitis with complications |
| K51.211 | Ulcerative (chronic) proctitis with rectal bleeding |
| K51.212 | Ulcerative (chronic) proctitis with intestinal obstruction |
| K51.213 | Ulcerative (chronic) proctitis with fistula |
| K51.214 | Ulcerative (chronic) proctitis with abscess |
| K51.218 | Ulcerative (chronic) proctitis with other complication |
| K51.219 | Ulcerative (chronic) proctitis with unspecified complications |
| K51.3 | Ulcerative (chronic) rectosigmoiditis |
| K51.30 | Ulcerative (chronic) rectosigmoiditis without complications |
| K51.31 | Ulcerative (chronic) rectosigmoiditis with complications |
| K51.311 | Ulcerative (chronic) rectosigmoiditis with rectal bleeding |
| K51.312 | Ulcerative (chronic) rectosigmoiditis with intestinal obstruction |
| K51.313 | Ulcerative (chronic) rectosigmoiditis with fistula |
| K51.314 | Ulcerative (chronic) rectosigmoiditis with abscess |
| K51.318 | Ulcerative (chronic) rectosigmoiditis with other complication |
| K51.319 | Ulcerative (chronic) rectosigmoiditis with unspecified complications |
| K51.5 | Left sided colitis |
| K51.50 | Left sided colitis without complications |
| K51.51 | Left sided colitis with complications |
| K51.511 | Left sided colitis with rectal bleeding |
| K51.512 | Left sided colitis with intestinal obstruction |
| K51.513 | Left sided colitis with fistula |
| K51.514 | Left sided colitis with abscess |
| K51.518 | Left sided colitis with other complication |
| K51.519 | Left sided colitis with unspecified complications |
| K51.8 | Other ulcerative colitis |
| K51.80 | Other ulcerative colitis without complications |
| K51.81 | Other ulcerative colitis with complications |
| K51.811 | Other ulcerative colitis with rectal bleeding |
| K51.812 | Other ulcerative colitis with intestinal obstruction |
| K51.813 | Other ulcerative colitis with fistula |
| K51.814 | Other ulcerative colitis with abscess |
| K51.818 | Other ulcerative colitis with other complication |
| K51.819 | Other ulcerative colitis with unspecified complications |
| K51.9 | Ulcerative colitis, unspecified |
| K51.90 | Ulcerative colitis, unspecified, without complications |
| K51.91 | Ulcerative colitis, unspecified, with complications |
| K51.911 | Ulcerative colitis, unspecified with rectal bleeding |
| K51.912 | Ulcerative colitis, unspecified with intestinal obstruction |
| K51.913 | Ulcerative colitis, unspecified with fistula |
| K51.914 | Ulcerative colitis, unspecified with abscess |
| K51.918 | Ulcerative colitis, unspecified with other complication |
| K51.919 | Ulcerative colitis, unspecified with unspecified complications |
Formulary Reference Tool