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Drug overview for THYMOGLOBULIN (lymphocyte immune globulin,rabbit):
Generic name: LYMPHOCYTE IMMUNE GLOBULIN,RABBIT (AN-ti THIGH-mow-site GLOB-ue-lin)
Drug class: Lymphocyte Immune Globulin
Therapeutic class: Biologicals
Antithymocyte globulin (rabbit) (ATG (rabbit)), a polyclonal antibody preparation, is an immunosuppressive agent.
No enhanced Uses information available for this drug.
Generic name: LYMPHOCYTE IMMUNE GLOBULIN,RABBIT (AN-ti THIGH-mow-site GLOB-ue-lin)
Drug class: Lymphocyte Immune Globulin
Therapeutic class: Biologicals
Antithymocyte globulin (rabbit) (ATG (rabbit)), a polyclonal antibody preparation, is an immunosuppressive agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for THYMOGLOBULIN (lymphocyte immune globulin,rabbit) have been approved by the FDA:
Indications:
Kidney transplant rejection
Professional Synonyms:
Renal transplant rejection
Indications:
Kidney transplant rejection
Professional Synonyms:
Renal transplant rejection
The following dosing information is available for THYMOGLOBULIN (lymphocyte immune globulin,rabbit):
Lymphocyte counts (i.e., total lymphocytes and/or T-cell subsets) should be monitored to assess the level of T-cell depletion in patients receiving ATG (rabbit). Total leukocyte cell counts (WBCs) and platelet counts also should be monitored and dosage of ATG (rabbit) reduced in patients who develop leukopenia and/or thrombocytopenia. If WBCs are 2000-3000/ mm3 or platelet counts are 50,000-75,000/ mm3, dosage of ATG (rabbit) should be reduced by 50%; discontinuance of the drug should be considered in those with WBCs less than 2000/ mm3 or platelet counts less than 50,000/ mm3.
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 THYMOGLOBULIN (lymphocyte immune globulin,rabbit):
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 |
|---|---|
| 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, M-M-R II VACCINE, PRIORIX, PROQUAD, ROTARIX, ROTATEQ, STAMARIL, VARIVAX VACCINE, VAXCHORA ACTIVE COMPONENT, VAXCHORA VACCINE, VIVOTIF, YF-VAX |
There are 5 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 |
|---|---|
| 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: Concurrent use of deferiprone and myelosuppressive agents may result in severe neutropenia or agranulocytosis, which may be fatal. 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) 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.(1-25) 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) |
| 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) |
CLOZAPINE, CLOZAPINE ODT, CLOZARIL, VERSACLOZ |
| Anti-thymocyte globulin/Belatacept SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The mechanism of this interaction is unknown.(1) CLINICAL EFFECTS: Concurrent use of anti-thymocyte globulin with belatacept may increase the risk of venous thrombosis of the renal allograft in de novo kidney transplant patients.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of belatacept states coadministration (at the same or nearly the same time) of anti-thymocyte globulin with the first dose of belatacept may pose a risk for venous thrombosis of the renal allograft in patients who are de novo kidney transplant recipients.(1) If anti-thymocyte globulin (or any other cell-depleting induction treatment) and belatacept will be administered concomitantly, a twelve-hour interval between the two administrations is suggested.(1) DISCUSSION: Based on postmarketing experience in de novo kidney transplant recipients, some with other predisposing risk factors for venous thrombosis of the renal allograft, venous thrombosis of the renal allograft has occurred when the initial dose of anti-thymocyte globulin, as immunosuppressive induction, was coadministered (at the same or nearly the same time) with the first dose of belatacept. In such patients, the coadministration (at the same or nearly the same time) of anti-thymocyte globulin and belatacept may pose a risk for venous thrombosis of the renal allograft. If anti-thymocyte globulin (or any other cell-depleting induction treatment) and belatacept will be administered concomitantly, a twelve-hour interval between the two administrations is suggested.(1) |
NULOJIX |
| 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 |
| 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 1 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 |
|---|---|
| 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 THYMOGLOBULIN (lymphocyte immune globulin,rabbit):
Drug contraindication overview.
Known hypersensitivity to rabbit proteins or any ingredient in the formulation;(9) history of anaphylaxis following receipt of ATG (rabbit). Acute viral illness.
Known hypersensitivity to rabbit proteins or any ingredient in the formulation;(9) history of anaphylaxis following receipt of ATG (rabbit). Acute viral illness.
There are 0 contraindications.
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Immunosuppression |
| Opportunistic fungal infection |
| Opportunistic viral infection |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Leukopenia |
| Thrombocytopenic disorder |
The following adverse reaction information is available for THYMOGLOBULIN (lymphocyte immune globulin,rabbit):
Adverse reaction overview.
Infectious complications, including sepsis, urinary tract infections, and cytomegalovirus (CMV) infections, have been reported in 37-50% of patients receiving ATG (rabbit) in conjunction with other immunosuppressive agents for the treatment of acute rejection of renal allografts. In one study, 29% of patients developed bacterial infections, 21% developed viral infections, and 9% developed fungal infections. Fever, chills, and leukopenia have been reported in 57-63% of patients receiving ATG (rabbit).
Adverse effects reported in 27-46% of patients include abdominal pain, nausea, diarrhea, asthenia, dyspnea, headache, hyperkalemia, hypertension, pain, peripheral edema, tachycardia, and thrombocytopenia. Dizziness and malaise were reported in about 8-13% of patients.
Infectious complications, including sepsis, urinary tract infections, and cytomegalovirus (CMV) infections, have been reported in 37-50% of patients receiving ATG (rabbit) in conjunction with other immunosuppressive agents for the treatment of acute rejection of renal allografts. In one study, 29% of patients developed bacterial infections, 21% developed viral infections, and 9% developed fungal infections. Fever, chills, and leukopenia have been reported in 57-63% of patients receiving ATG (rabbit).
Adverse effects reported in 27-46% of patients include abdominal pain, nausea, diarrhea, asthenia, dyspnea, headache, hyperkalemia, hypertension, pain, peripheral edema, tachycardia, and thrombocytopenia. Dizziness and malaise were reported in about 8-13% of patients.
There are 24 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bacterial sepsis Fever Hyperkalemia Hypertension Infection Leukopenia Thrombocytopenic disorder Urinary tract infection |
Anemia Cytomegalovirus disease Gastritis Herpes simplex infection Herpes zoster Lower respiratory infection Neutropenic disorder Thrombophlebitis |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Anaphylaxis Cytokine release syndrome Hemolysis Increased risk of bleeding due to coagulation disorder Infectious mononucleosis Malignancy Serum sickness |
There are 22 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Chills Constipation Diarrhea Dyspnea Headache disorder Nausea Pain Peripheral edema Tachycardia |
Dizziness Dyspepsia General weakness Hyperlipidemia Injection site sequelae Insomnia Malaise Oral candidiasis Pruritus of skin Skin rash Symptoms of anxiety Upper respiratory infection |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for THYMOGLOBULIN (lymphocyte immune globulin,rabbit):
Safety and efficacy of ATG (rabbit) not established in children younger than 18 years of age. A limited number of pediatric patients 2.5-18 years of age have received ATG (rabbit) (1.5-2.5 mg/kg daily for 5 days) in conjunction with other immunosuppressive agents to prevent or delay the onset of renal allograft rejection; adverse effects in these patients appear to be similar to those reported in adults.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.)
Not known whether ATG (rabbit) is distributed into milk. However, many drugs are distributed into human milk, including antibodies; also consider potential for adverse effects. Discontinue nursing or drug, taking into account the importance of the drug to the mother.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for THYMOGLOBULIN (lymphocyte immune globulin,rabbit):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for THYMOGLOBULIN (lymphocyte immune globulin,rabbit)'s list of indications:
| Kidney transplant rejection | |
| T86.11 | Kidney transplant rejection |
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