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Drug overview for GAMMAPLEX (WITH SORBITOL) (immune globulin,gamm(igg)/sorbitol/glycin/iga 0 to 50 mcg/ml):
Generic name: immune globulin,gamm(IgG)/sorbitol/glycin/IgA 0 to 50 mcg/mL (ih-MYOON GLOB-you-lin)
Drug class: Immune Globulin, Gamma (IGG)
Therapeutic class: Biologicals
Immune globulin IM (IGIM), immune globulin IV (IGIV), and immune globulin subcutaneous are sterile, nonpyrogenic preparations of globulins containing many antibodies normally present in adult human blood.
No enhanced Uses information available for this drug.
Generic name: immune globulin,gamm(IgG)/sorbitol/glycin/IgA 0 to 50 mcg/mL (ih-MYOON GLOB-you-lin)
Drug class: Immune Globulin, Gamma (IGG)
Therapeutic class: Biologicals
Immune globulin IM (IGIM), immune globulin IV (IGIV), and immune globulin subcutaneous are sterile, nonpyrogenic preparations of globulins containing many antibodies normally present in adult human blood.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for GAMMAPLEX (WITH SORBITOL) (immune globulin,gamm(igg)/sorbitol/glycin/iga 0 to 50 mcg/ml) have been approved by the FDA:
Indications:
Agammaglobulinemia
Chronic idiopathic thrombocytopenic purpura
Common variable agammaglobulinemia
Primary immune deficiency disorder
Severe combined immunodeficiency disease
Wiskott-Aldrich syndrome
X-linked agammaglobulinemia
Professional Synonyms:
Abnormal decrease of gamma globulin level
Bruton's agammaglobulinemia
Bruton's hypogammaglobulinemia
Chronic immune thrombocytopenia purpura
Chronic ITP
Combined T-cell and B-cell immunodeficiency
Common variable immunodeficiency
Immunodeficiency with thrombocytopenia and eczema
Primary antibody deficiency disorders
Primary immune deficiency diseases
Wiskott-Aldrich-Huntley syndrome
Indications:
Agammaglobulinemia
Chronic idiopathic thrombocytopenic purpura
Common variable agammaglobulinemia
Primary immune deficiency disorder
Severe combined immunodeficiency disease
Wiskott-Aldrich syndrome
X-linked agammaglobulinemia
Professional Synonyms:
Abnormal decrease of gamma globulin level
Bruton's agammaglobulinemia
Bruton's hypogammaglobulinemia
Chronic immune thrombocytopenia purpura
Chronic ITP
Combined T-cell and B-cell immunodeficiency
Common variable immunodeficiency
Immunodeficiency with thrombocytopenia and eczema
Primary antibody deficiency disorders
Primary immune deficiency diseases
Wiskott-Aldrich-Huntley syndrome
The following dosing information is available for GAMMAPLEX (WITH SORBITOL) (immune globulin,gamm(igg)/sorbitol/glycin/iga 0 to 50 mcg/ml):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for GAMMAPLEX (WITH SORBITOL) (immune globulin,gamm(igg)/sorbitol/glycin/iga 0 to 50 mcg/ml):
There are 1 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 |
|---|---|
| Selected Live Viral Vaccines/Selected Immunoglobulins 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: Immune globulin(IG) products may prevent the immune system from properly responding to the vaccine.(1-19) CLINICAL EFFECTS: Administration of selected live viral vaccines after immunoglobulins may impair the efficacy of the vaccine.(1-19) Administration of immunoglobulins within 2-4 weeks after selected live viral vaccines impair the efficacy of the vaccine.(1-4,15) PREDISPOSING FACTORS: The amount of antigen-specific antibody present in the administered immunoglobulin product determines the duration of this interaction.(15) PATIENT MANAGEMENT: The recommendations regarding this interaction are conflicting. The Centers for Disease Control and Prevention(CDC) immunization recommendations for spacing of live vaccines and antibody-containing products include the following(15): - Live attenuated influenza vaccine, rotavirus, zoster and Ty21a typhoid vaccines may be given any time before, concurrent, with, or after administration of any immune globulin. Yellow fever vaccine may also be given in areas where donor blood products are unlikely to contain a substantial quantity of yellow fever antibody. - Administration of measles or varicella containing vaccines should be postponed for the following intervals after immunoglobulin therapy: Hepatitis B IG, Tetanus IG - 3 months Rabies IG - 4 months Varicella IG - 5 months Measles prophylaxis IG - 6 months if nonimmunocompromised Botulinum IG Intravenous, CMV IG Intravenous, Hepatitis A IG - 6 months Intravenous Immune Globulin(IVIG) - 8 to 11 months depending upon the dose Monoclonal antibody to RSV F protein (palivizumab) - none - Administration of antibody-containing products should be delayed 2 weeks after administration of live vaccines, except for influenza, rotavirus, zoster and typhoid vaccines as noted above. CDC guidelines state that in circumstances where there is high-risk of vaccine-preventable disease, it is acceptable to administer a dose of vaccine prior to completion of these intervals.(16) Manufacturer recommendations are as follows: Administration of a live viral vaccine should be postponed for at least three months in patients who have received the following immunoglobulin therapy: anthrax immunoglobulin,(19) cytomegalovirus immunoglobulin,(1) hepatitis B immunoglobulin,(5,6) rabies immunoglobulin,(7) tetanus immunoglobulin,(8-11) vaccinia immunoglobulin,(18) and zoster immunoglobulin.(2) Administration of a live viral vaccine should be postponed for at least six months in patients who have received the following immunoglobulin therapy: botulinum neurotoxin a/b immune globulin.(17) The Australian, Canadian, and US manufacturers of human immunoglobulin state that live viral vaccines should be postponed for three months in patients who have received human immunoglobulin.(6,12,13,18) The UK manufacturer states that vaccines may be compromised for one year and vaccines should be postponed in children for at least seven months.(14) The US manufacturer of immune globulin-hyaluronidase states that immune response to live attenuated vaccines may be impaired for up to 6 months, or for a year or more in the case of measles vaccine.(15) Cytomegalovirus immunoglobulin(1) or human immunoglobulin(3) should not be administered to patients who have received a live vaccine in the previous two weeks. If a live viral vaccine is given within two weeks of zoster immunoglobulin,(1) repetition of the vaccination three months after the completion of immunoglobulin should be considered. DISCUSSION: CDC Immunization Recommendations(15)provide discussion, charts, and further details regarding appropriate use and timing of vaccine therapy.(16) |
ADENOVIRUS TYPE 4, ADENOVIRUS TYPE 4 AND TYPE 7, ADENOVIRUS TYPE 7, DENGVAXIA, M-M-R II VACCINE, PRIORIX, PROQUAD, STAMARIL, VARIVAX VACCINE, YF-VAX |
There are 3 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 |
|---|---|
| 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 |
| Pozelimab/Intravenous Immunoglobulin 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 intravenous immunoglobulin which binds 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 |
| IgG Antibodies and Derivatives/Nipocalimab-aahu 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) Nipocalimab-aahu 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 nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3) |
IMAAVY |
There are 3 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 |
|---|---|
| Selected Human Immunoglobulins/Estrogens SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Concurrent use of human immunoglobulin with estrogens may have additive effects on clotting mechanisms.(1) CLINICAL EFFECTS: Concurrent use of human immunoglobulin with estrogens may increase the risk of thrombosis. Thrombosis may occur regardless of the route of administration of the immunoglobulin.(1) PREDISPOSING FACTORS: Additional risk factors include advanced age, prolonged immobilization, hypercoagulable states, history of arterial or venous thrombosis, indwelling central vascular catheter, hyperviscosity and cardiovascular risk factors (e.g. coronary artery disease, hypertension, diabetes).(1) PATIENT MANAGEMENT: For patients at risk of thrombosis, administer the minimum concentration of immunoglobulin available at the minimum rate of infusion practicable. Ensure that patients are adequately hydrated before immunoglobulin is infused. Patients should be monitored for signs and symptoms of thrombosis. Assess blood viscosity in patients at risk for hyperviscosity. Counsel patients on the risk of thrombosis and its signs and symptoms. Instruct patients to promptly report any symptoms of thrombosis.(1) DISCUSSION: Thrombosis has been associated with the use of human immunoglobulin and may occur without the presence of risk factors and regardless of the route of administration of the immunoglobulin. Risk factors known to increase the risk of thrombosis include the use of estrogens, advanced age, prolonged immobilization, hypercoagulable states, history of arterial or venous thrombosis, indwelling central vascular catheter, hyperviscosity and cardiovascular risk factors (e.g. coronary artery disease, hypertension, diabetes). For patients at risk of thrombosis, administer the minimum concentration of immunoglobulin available at the minimum rate of infusion practicable. Ensure that patients are adequately hydrated before immunoglobulin is infused. Patients should be monitored for signs and symptoms of thrombosis. Assess blood viscosity in patients at risk for hyperviscosity. Counsel patients on the risk of thrombosis and its signs and symptoms. Instruct patients to promptly report any symptoms of thrombosis.(1) |
2-METHOXYESTRADIOL, ACTIVELLA, AFIRMELLE, ALTAVERA, ALYACEN, AMETHIA, AMETHYST, ANGELIQ, ANNOVERA, APRI, ARANELLE, ASHLYNA, AUBRA, AUBRA EQ, AUROVELA, AUROVELA 24 FE, AUROVELA FE, AVIANE, AYUNA, AZURETTE, BALCOLTRA, BALZIVA, BEYAZ, BIJUVA, BLISOVI 24 FE, BLISOVI FE, BRIELLYN, CAMRESE, CAMRESE LO, CAZIANT, CHARLOTTE 24 FE, CHATEAL EQ, CLIMARA, CLIMARA PRO, COMBIPATCH, COVARYX, COVARYX H.S., CRYSELLE, CYRED, CYRED EQ, DASETTA, DAYSEE, DELESTROGEN, DEPO-ESTRADIOL, DESOGESTR-ETH ESTRAD ETH ESTRA, DIETHYLSTILBESTROL, DIVIGEL, DOLISHALE, DOTTI, DROSPIRENONE-ETH ESTRA-LEVOMEF, DROSPIRENONE-ETHINYL ESTRADIOL, DUAVEE, EEMT, EEMT H.S., ELESTRIN, ELINEST, ELURYNG, ENILLORING, ENPRESSE, ENSKYCE, ESTARYLLA, ESTRACE, ESTRADIOL, ESTRADIOL (ONCE WEEKLY), ESTRADIOL (TWICE WEEKLY), ESTRADIOL BENZOATE, ESTRADIOL CYPIONATE, ESTRADIOL HEMIHYDRATE, ESTRADIOL HEMIHYDRATE MICRO, ESTRADIOL MICRONIZED, ESTRADIOL VALERATE, ESTRADIOL-NORETHINDRONE ACETAT, ESTRATEST F.S., ESTRATEST H.S., ESTRING, ESTRIOL, ESTRIOL MICRONIZED, ESTROGEL, ESTROGEN-METHYLTESTOSTERONE, ESTRONE, ETHINYL ESTRADIOL, ETHYNODIOL-ETHINYL ESTRADIOL, ETONOGESTREL-ETHINYL ESTRADIOL, EVAMIST, FALMINA, FEIRZA, FEMLYV, FEMRING, FINZALA, FYAVOLV, GALBRIELA, GEMMILY, HAILEY, HAILEY 24 FE, HAILEY FE, HALOETTE, ICLEVIA, ISIBLOOM, JAIMIESS, JASMIEL, JINTELI, JOLESSA, JOYEAUX, JULEBER, JUNEL, JUNEL FE, JUNEL FE 24, KAITLIB FE, KALLIGA, KARIVA, KELNOR 1-35, KELNOR 1-50, KURVELO, LARIN, LARIN 24 FE, LARIN FE, LAYOLIS FE, LEENA, LESSINA, LEVONEST, LEVONORG-ETH ESTRAD ETH ESTRAD, LEVONORG-ETH ESTRAD-FE BISGLYC, LEVONORGESTREL-ETH ESTRADIOL, LEVORA-28, LO LOESTRIN FE, LO-ZUMANDIMINE, LOESTRIN, LOESTRIN FE, LOJAIMIESS, LORYNA, LOW-OGESTREL, LUTERA, LYLLANA, MARLISSA, MENEST, MENOSTAR, MERZEE, MIBELAS 24 FE, MICROGESTIN, MICROGESTIN FE, MILI, MIMVEY, MINIVELLE, MINZOYA, MONO-LINYAH, MYFEMBREE, NATAZIA, NECON, NEXTSTELLIS, NIKKI, NORELGESTROMIN-ETH ESTRADIOL, NORETHIN-ETH ESTRA-FERROUS FUM, NORETHINDRON-ETHINYL ESTRADIOL, NORETHINDRONE-E.ESTRADIOL-IRON, NORGESTIMATE-ETHINYL ESTRADIOL, NORTREL, NUVARING, NYLIA, OCELLA, ORIAHNN, ORTHO TRI-CYCLEN, ORTHO-NOVUM, PHILITH, PIMTREA, PORTIA, PREMARIN, PREMPHASE, PREMPRO, RECLIPSEN, RIVELSA, ROSYRAH, SAFYRAL, SETLAKIN, SIMLIYA, SIMPESSE, SPRINTEC, SRONYX, SYEDA, TARINA 24 FE, TARINA FE, TARINA FE 1-20 EQ, TAYTULLA, TILIA FE, TRI-ESTARYLLA, TRI-LEGEST FE, TRI-LINYAH, TRI-LO-ESTARYLLA, TRI-LO-MARZIA, TRI-LO-MILI, TRI-LO-SPRINTEC, TRI-MILI, TRI-SPRINTEC, TRI-VYLIBRA, TRI-VYLIBRA LO, TRIVORA-28, TURQOZ, TWIRLA, TYBLUME, VAGIFEM, VALTYA, VELIVET, VESTURA, VIENVA, VIORELE, VIVELLE-DOT, VOLNEA, VYFEMLA, VYLIBRA, WERA, WYMZYA FE, XARAH FE, XELRIA FE, XULANE, YASMIN 28, YAZ, YUVAFEM, ZAFEMY, ZARAH, ZOVIA 1-35, ZUMANDIMINE |
| Selected Nephrotoxic Agents/Immune Globulin IV (IGIV) SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Immune Globulin Intravenous (IGIV) products, particularly those containing sucrose, can cause renal dysfunction, acute renal failure, osmotic nephrosis, and/or death. Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1-4) CLINICAL EFFECTS: Concurrent use of Immune Globulin Intravenous (IGIV) products with nephrotoxic agents such as adefovir, intravenous aminoglycosides, amphotericin B, non-steroidal anti-inflammatory agents, tenofovir, and vancomycin may result in renal toxicity.(1-4) Other nephrotoxic agents include capreomycin, gallium nitrate, and streptozocin. PREDISPOSING FACTORS: Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs.(1-4) Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose.(3-4) PATIENT MANAGEMENT: For patients at risk of renal dysfunction or renal failure, the US manufacturers of Immune Globulin Intravenous (IGIV) products recommends administration at the minimum dose and infusion rate practicable; ensure adequate hydration in patients before administration; and monitor renal function and urine output with assessment of blood urea nitrogen (BUN) and serum creatinine before initial infusion and at regular intervals during therapy.(1-3) Concurrent administration of potentially nephrotoxic agents should be avoided.(1) Review prescribing information for IGIV product to be administered for sucrose content. If concurrent therapy is warranted, monitor renal function closely. In high risk patients, consider selecting an IGIV product that does not contain sucrose. DISCUSSION: The safety of Immune Globulin Intravenous (IGIV) has not been studied in patients receiving other known potentially nephrotoxic agents. Renal impairment is a major toxicity of IGIV products.(1-3) A review of the FDA renal adverse events (RAEs) (i.e. acute renal failure or insufficiency) from June 1985 to November 1998 identified 120 reports worldwide associated with IGIV administration. In the US, the FDA received 88 reports of cases with clinical and/or laboratory findings consistent with RAE (i.e. increased serum creatinine, oliguria, and acute renal failure). Patient cases involved a median age of 60.5 years and 55% were male. Of the 54 patients who developed acute renal failure, 65% were greater than 65 years, 56% had diabetes, and 26% had prior renal insufficiency; 59% had one, 35% had two, and 6% had three of these conditions. Upon review of the IGIV product received, 90% of cases received sucrose-containing IGIV products with the remaining patients receiving either maltose- or glucose-containing products. Approximately 40% of affected patients required dialysis and RAE may have contributed to death in 15% of patients.(4) |
ABELCET, ADEFOVIR DIPIVOXIL, AMBISOME, AMIKACIN SULFATE, AMPHOTERICIN B, AMPHOTERICIN B LIPOSOME, ANAPROX DS, ANJESO, ARTHROTEC 50, ARTHROTEC 75, BIKTARVY, BROMFENAC SODIUM, BUPIVACAINE-KETOROLAC-KETAMINE, CALDOLOR, CELEBREX, CELECOXIB, CIMDUO, COMBOGESIC, COMBOGESIC IV, COMPLERA, CONSENSI, COXANTO, DAYPRO, DELSTRIGO, DESCOVY, DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM ER, DICLOFENAC SODIUM MICRONIZED, DICLOFENAC SODIUM-MISOPROSTOL, EC-NAPROSYN, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, ELYXYB, EMTRICITABINE-RILPIVIRNE-TENOF, EMTRICITABINE-TENOFOVIR DISOP, ETODOLAC, ETODOLAC ER, FELDENE, FENOPROFEN CALCIUM, FENOPRON, FLURBIPROFEN, GENTAMICIN SULFATE, GENTAMICIN SULFATE IN NS, GENVOYA, HEPSERA, HYDROCODONE-IBUPROFEN, IBU, IBUPAK, IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN-FAMOTIDINE, INDOCIN, INDOMETHACIN, INDOMETHACIN ER, INFLAMMACIN, INFLATHERM(DICLOFENAC-MENTHOL), KANAMYCIN SULFATE, KETOPROFEN, KETOPROFEN MICRONIZED, KETOROLAC TROMETHAMINE, KIPROFEN, LODINE, LOFENA, LURBIPR, MECLOFENAMATE SODIUM, MEFENAMIC ACID, MELOXICAM, NABUMETONE, NABUMETONE MICRONIZED, NALFON, NAPRELAN, NAPROSYN, NAPROTIN, NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM CR, NAPROXEN SODIUM ER, NAPROXEN-ESOMEPRAZOLE MAG, NEOMYCIN SULFATE, NEOPROFEN, ODEFSEY, OXAPROZIN, PHENYLBUTAZONE, PIROXICAM, R.E.C.K.(ROPIV-EPI-CLON-KETOR), RELAFEN DS, ROPIVACAINE-CLONIDINE-KETOROLC, ROPIVACAINE-KETOROLAC-KETAMINE, SPRIX, STREPTOMYCIN SULFATE, STRIBILD, SULINDAC, SUMATRIPTAN SUCC-NAPROXEN SOD, SYMBRAVO, SYMFI, SYMTUZA, TENOFOVIR DISOPROXIL FUMARATE, TOBRAMYCIN, TOBRAMYCIN SULFATE, TOLECTIN 600, TOLMETIN SODIUM, TORONOVA II SUIK, TORONOVA SUIK, TOXICOLOGY SALIVA COLLECTION, TRESNI, TREXIMET, TRUVADA, VANCOMYCIN, VANCOMYCIN HCL, VANCOMYCIN HCL-0.9% NACL, VANCOMYCIN HCL-D5W, VEMLIDY, VIMOVO, VIREAD, VIVLODEX, ZANOSAR, ZIPSOR, ZORVOLEX, ZYNRELEF |
| 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 GAMMAPLEX (WITH SORBITOL) (immune globulin,gamm(igg)/sorbitol/glycin/iga 0 to 50 mcg/ml):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Predisposition to thrombosis |
| Thromboembolic disorder |
There are 10 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Atherosclerotic cardiovascular disease |
| Bed-ridden |
| Diabetes mellitus |
| Hemolytic anemia |
| Hypertension |
| Hypovolemia |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Monoclonal gammopathy |
| Sepsis |
| Transfusion related acute lung injury |
The following adverse reaction information is available for GAMMAPLEX (WITH SORBITOL) (immune globulin,gamm(igg)/sorbitol/glycin/iga 0 to 50 mcg/ml):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 32 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Tachycardia |
Dyspnea Wheezing |
| Rare/Very Rare |
|---|
|
Acute myocardial infarction Anaphylaxis Angioedema Bronchospastic pulmonary disease Bullous dermatitis Cerebrovascular accident Chest pain Cyanosis Disseminated intravascular coagulation Erythema multiforme Hemolysis Hemolytic anemia Hyperproteinemia Hypertension Hypotension Kidney disease with reduction in glomerular filtration rate (GFr) Leukopenia Migraine Non-infective meningitis Pancytopenia Pseudohyponatremia Pulmonary edema Pulmonary thromboembolism Renal failure Seizure disorder Stevens-johnson syndrome Thromboembolic disorder Thrombotic disorder Transfusion related acute lung injury |
There are 36 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Arthralgia Chills Cough Diarrhea Dizziness Earache Edema Fatigue Fever Headache disorder Injection site sequelae Nausea Pharyngitis Skin rash Vomiting |
Cramps Injection site pain Malaise Nasal congestion Symptoms of anxiety |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Agitation Back pain Body fluid retention Flushing General weakness Hematuria Hypoesthesia Myalgia Paresthesia Photophobia Pruritus of skin Tremor Urine discoloration Urticaria |
The following precautions are available for GAMMAPLEX (WITH SORBITOL) (immune globulin,gamm(igg)/sorbitol/glycin/iga 0 to 50 mcg/ml):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Animal reproduction studies have not been performed with IGIM, IGIV, or immune globulin subcutaneous and it is not known whether immune globulins can cause fetal harm when administered to pregnant women. Some manufacturers state that immune globulin should be used during pregnancy only when clearly needed. ACIP states that there are no known risks associated with use of immune globulins for passive immunization in pregnant women.
Intact immune globulins, such as those contained in IGIV, cross the placenta in increasing amounts after 30 weeks of gestation. Results of studies in pregnant women with ITP who received IGIV prior to delivery indicate that the platelet response and clinical effects of IGIV were similar in the mother and neonate. Animal reproduction studies have been performed with the recombinant human hyaluronidase component of immune globulin subcutaneous 10% with recombinant human hyaluronidase (Hyqvia(R)).
In mice and rabbits, antibodies to recombinant human hyaluronidase (anti-rHuPH20 antibodies) that developed in the mother were not associated with adverse effects on pregnancy; these antibodies crossed the placenta and were transferred to offspring in utero. It is not known whether anti-recombinant human hyaluronidase antibodies that develop in women cause fetal harm. The manufacturer states that Hyqvia(R) should be used during pregnancy only if clearly needed,
Intact immune globulins, such as those contained in IGIV, cross the placenta in increasing amounts after 30 weeks of gestation. Results of studies in pregnant women with ITP who received IGIV prior to delivery indicate that the platelet response and clinical effects of IGIV were similar in the mother and neonate. Animal reproduction studies have been performed with the recombinant human hyaluronidase component of immune globulin subcutaneous 10% with recombinant human hyaluronidase (Hyqvia(R)).
In mice and rabbits, antibodies to recombinant human hyaluronidase (anti-rHuPH20 antibodies) that developed in the mother were not associated with adverse effects on pregnancy; these antibodies crossed the placenta and were transferred to offspring in utero. It is not known whether anti-recombinant human hyaluronidase antibodies that develop in women cause fetal harm. The manufacturer states that Hyqvia(R) should be used during pregnancy only if clearly needed,
IGIV and immune globulin subcutaneous have not been evaluated in nursing women. It is not known whether immune globulin is distributed into milk following IM, IV, or subcutaneous administration, affects milk production, or affects the breast-fed infant. Immune globulin should be used with caution in nursing women.
The benefits of breast-feeding and the importance of immune globulin to the woman should be considered along with the potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. The manufacturer of immune globulin subcutaneous 10% with recombinant human hyaluronidase (Hyqvia(R)) states that data are not available regarding use in nursing women. In lactating animals, maternal antibodies bound to recombinant human hyaluronidase (anti-rHuPH20 antibodies) were transferred to nursing offspring; no adverse effects on pregnancy or offspring development were associated with these antibodies. The possible effects of these antibodies to recombinant human hyaluronidase that may be transferred to infants are unknown.
The benefits of breast-feeding and the importance of immune globulin to the woman should be considered along with the potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. The manufacturer of immune globulin subcutaneous 10% with recombinant human hyaluronidase (Hyqvia(R)) states that data are not available regarding use in nursing women. In lactating animals, maternal antibodies bound to recombinant human hyaluronidase (anti-rHuPH20 antibodies) were transferred to nursing offspring; no adverse effects on pregnancy or offspring development were associated with these antibodies. The possible effects of these antibodies to recombinant human hyaluronidase that may be transferred to infants are unknown.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for GAMMAPLEX (WITH SORBITOL) (immune globulin,gamm(igg)/sorbitol/glycin/iga 0 to 50 mcg/ml):
WARNING: This medication may cause serious (rarely fatal) kidney problems. The risk is higher if you have kidney problems, diabetes, a serious blood infection (sepsis), a certain blood problem (paraproteinemia), or a severe loss of body fluids (dehydration), as well as if you are older than 65 years or are taking other drugs that may harm the kidneys (such as gentamicin). This medication may also rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs).
You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for giving medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, discuss the risks and benefits and if you have any of these conditions, report them to your doctor or pharmacist.
The risk of kidney problems and blood clots may be decreased by infusing this medication more slowly or by using a less concentrated form of this medication if available. Being adequately hydrated before receiving this medication may also help reduce these risks. Get medical help right away if any of these side effects occur: sudden weight gain, swelling of the hands/ankles/feet, a change in the amount/color of urine, foamy/frothy urine, shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the arm/leg, sudden/severe headache, trouble speaking, weakness on one side of the body, sudden vision changes, or confusion.
WARNING: This medication may cause serious (rarely fatal) kidney problems. The risk is higher if you have kidney problems, diabetes, a serious blood infection (sepsis), a certain blood problem (paraproteinemia), or a severe loss of body fluids (dehydration), as well as if you are older than 65 years or are taking other drugs that may harm the kidneys (such as gentamicin). This medication may also rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs).
You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for giving medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, discuss the risks and benefits and if you have any of these conditions, report them to your doctor or pharmacist.
The risk of kidney problems and blood clots may be decreased by infusing this medication more slowly or by using a less concentrated form of this medication if available. Being adequately hydrated before receiving this medication may also help reduce these risks. Get medical help right away if any of these side effects occur: sudden weight gain, swelling of the hands/ankles/feet, a change in the amount/color of urine, foamy/frothy urine, shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the arm/leg, sudden/severe headache, trouble speaking, weakness on one side of the body, sudden vision changes, or confusion.
The following icd codes are available for GAMMAPLEX (WITH SORBITOL) (immune globulin,gamm(igg)/sorbitol/glycin/iga 0 to 50 mcg/ml)'s list of indications:
| Agammaglobulinemia | |
| D80.0 | Hereditary hypogammaglobulinemia |
| D80.1 | Nonfamilial hypogammaglobulinemia |
| Chronic idiopathic thrombocytopenic purpura | |
| D69.3 | Immune thrombocytopenic purpura |
| Common variable agammaglobulinemia | |
| D80.1 | Nonfamilial hypogammaglobulinemia |
| D83 | Common variable immunodeficiency |
| D83.0 | Common variable immunodeficiency with predominant abnormalities of b-cell numbers and function |
| D83.1 | Common variable immunodeficiency with predominant immunoregulatory t-cell disorders |
| D83.2 | Common variable immunodeficiency with autoantibodies to b- or t-cells |
| D83.8 | Other common variable immunodeficiencies |
| D83.9 | Common variable immunodeficiency, unspecified |
| Primary immune deficiency disorder | |
| D84.9 | Immunodeficiency, unspecified |
| Severe combined immunodeficiency disease | |
| D81.0 | Severe combined immunodeficiency [SCId] with reticular dysgenesis |
| D81.1 | Severe combined immunodeficiency [SCId] with low t- and b-cell numbers |
| D81.2 | Severe combined immunodeficiency [SCId] with low or normal b-cell numbers |
| D81.31 | Severe combined immunodeficiency due to adenosine deaminase deficiency |
| Wiskott-aldrich syndrome | |
| D82.0 | Wiskott-aldrich syndrome |
| X-linked agammaglobulinemia | |
| D80.0 | Hereditary hypogammaglobulinemia |
Formulary Reference Tool