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Antithymocyte globulin (horse derived, Atgam): Drug information

Antithymocyte globulin (horse derived, Atgam): Drug information
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For additional information see "Antithymocyte globulin (horse derived, Atgam): Patient drug information" and "Antithymocyte globulin (horse derived, Atgam): Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Anaphylaxis

Anaphylaxis has been reported with the use of antithymocyte globulin (equine). Antithymocyte globulin (equine) can cause potentially life-threatening anaphylaxis when injected intravenously. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion.

Brand Names: US
  • Atgam
Brand Names: Canada
  • Atgam
Pharmacologic Category
  • Immune Globulin;
  • Immunosuppressant Agent;
  • Polyclonal Antibody
Dosing: Adult

Dosage guidance:

Safety: Test dose: While a skin test is recommended by the manufacturer prior to administration of the initial dose (to identify patients at highest risk for anaphylaxis), anaphylaxis may still occur in patients who display negative skin tests. An allergist should be consulted for epicutaneous/prick and intradermal testing and interpretation. Initial testing has been performed with an epicutaneous prick of undiluted antithymocyte globulin (ATG); if no wheal in 10 minutes, then use 0.02 mL intradermally of a 1:1,000 dilution of ATG in normal saline along with a separate saline control of 0.02 mL; observe in 10 minutes. A positive skin reaction consists of a wheal with the initial prick test (undiluted) or ≥3 mm in diameter larger than the saline control with the diluted intradermal test. Alternatively, a 0.1 mL test dose (5 mg/mL concentration) may be administered intradermally along with a separate saline control; erythema larger than 5 mm in diameter (compared to the control) is considered a positive test (Ref). A positive skin test is suggestive of an increased risk for hypersensitivity and/or systemic allergic reactions (including anaphylaxis) with ATG IV infusion and alternative forms of treatment should be considered. Allergic reactions, including anaphylaxis, have occurred in patients with negative skin tests; skin testing does not show risk of delayed hypersensitivity reactions, including serum sickness.

Consider premedication with an antihistamine, corticosteroids, and/or an antipyretic. Concomitant immunosuppressants should also be administered.

Aplastic anemia, moderate to severe

Aplastic anemia, moderate to severe: IV: 10 to 20 mg/kg once daily for 8 to 14 days, then if needed, may administer every other day for 7 more doses for a total of 21 doses in 28 days or

Aplastic anemia, severe (off-label dosing): IV: 40 mg/kg once daily for 4 days (in combination with cyclosporine) (Ref) or 40 mg/kg once daily for 4 consecutive days (in combination with cyclosporine and eltrombopag) (Ref).

Graft-versus-host disease, acute, treatment

Graft-versus-host disease, acute, treatment (off-label use): IV: 30 mg/kg every other day for 6 doses (Ref) or 15 mg/kg twice daily for 10 doses (Ref).

Kidney transplantation

Kidney transplantation (alternative agent): Note: May be considered as an alternative to rabbit antithymocyte globulin (eg, history of serum sickness), in combination with other immunosuppressants (Ref).

Induction therapy (off-label use): IV: 15 mg/kg/day for at least 7 days starting on postoperative day 0 (Ref).

Rejection: IV: 10 to 15 mg/kg/day for 7 to 14 days; then if needed, may administer every other day for 7 more doses for a total of 21 doses in 28 days (Ref).

Lung transplant, induction therapy

Lung transplant, induction therapy (off- label use): IV: 5 to 15 mg/kg daily for the first 3 days after transplant (Ref). Additional data may be necessary to further define the role of antithymocyte globulin (equine) in this condition.

Myelodysplastic syndromes, lower risk, refractory

Myelodysplastic syndromes, lower risk, refractory (off-label use): IV: 40 mg/kg once daily for 4 days (in combination with prednisone); an intradermal test dose was administered prior to treatment (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Obesity: Adult

American Society for Blood and Marrow Transplantation practice guideline committee position statement on conditioning chemotherapy dosing in adults with a BMI ≥30 kg/m2: Utilize actual body weight to calculate weight-based dosing for hematopoietic cell transplant conditioning regimens (Ref).

Dosing: Adjustment for Toxicity: Adult

Anaphylaxis: Discontinue infusion immediately; administer epinephrine. May require corticosteroids, respiration assistance, and/or other resuscitative measures. Do not resume infusion.

Hemolysis (severe and unremitting): May require discontinuation of treatment.

Hematologic toxicity: Neutropenia and thrombocytopenia: Consider discontinuing antithymocyte globulin (equine) if severe or unremitting neutropenia and/or thrombocytopenia occurs. Consider platelet transfusions to maintain acceptable platelet levels during treatment (Ref).

Kidney transplant recipients:

White blood cell count in kidney transplant recipients: Reduce dose by 50% if WBC between 2,000 and 3,000 cells/mm3; hold dose if WBC <2,000 cells/mm3 (Ref).

Thrombocytopenia in kidney transplant recipients: Reduce dose by 50% if platelet count between 50,000 and 75,000 cells/mm3; hold dose if platelet count <50,000 cells/mm3 (Ref).

Dosing: Older Adult

Refer to adult dosing. Begin at the lower end of dosing ranges.

Dosing: Pediatric

(For additional information see "Antithymocyte globulin (horse derived, Atgam): Pediatric drug information")

Dosage guidance:

Safety: While a skin test is recommended by the manufacturer prior to administration of the initial dose (to identify patients at highest risk for anaphylaxis), anaphylaxis may still occur in patients who display negative skin tests. An allergist should be consulted for epicutaneous/prick and intradermal testing protocol and interpretation.

Aplastic anemia, moderate to severe when no HLA-matched sibling donor

Aplastic anemia, moderate to severe when no HLA-matched sibling donor:

Manufacturer's labeling: Children and Adolescents: IV: 10 to 20 mg/kg/dose once daily for 8 to 14 days; then if needed, may administer every other day up to a total of 21 doses in 28 days.

Alternate dosing (in combination with cyclosporine): Limited data available: Children ≥2 years and Adolescents: IV: 40 mg/kg/dose once daily for 4 days (Ref).

Graft-versus-host disease, acute, steroid resistant, treatment

Graft-versus-host disease, acute, steroid resistant, treatment: Limited data available: Children and Adolescents: IV: 30 mg/kg/dose every other day for 6 doses (Ref) or 15 mg/kg/dose twice daily for 10 doses (Ref).

Transplant, kidney; rejection treatment

Transplant, kidney; rejection treatment: Children and Adolescents: IV: 10 to 15 mg/kg/dose once daily for 14 days, then if needed, may administer every other day up to a total of 21 doses in 28 days.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; abnormal kidney function tests have been reported with therapy for aplastic anemia; use caution.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; abnormal liver function tests have been reported with therapy; use caution.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Dermatologic: Skin rash (26%)

Hematologic & oncologic: Leukopenia (18%), thrombocytopenia (22%)

Nervous system: Chills (27%)

Neuromuscular & skeletal: Arthralgia (17%)

Miscellaneous: Fever (40%)

1% to 10%:

Cardiovascular: Arteriovenous fistula site complication (thrombosis) (1%), bradycardia (2%), chest pain (3%), edema (2%), hypertension (3%), hypotension (3%), tachycardia (1%), thrombophlebitis (3%)

Dermatologic: Pruritus (5%), urticaria (9%)

Gastrointestinal: Diarrhea (3%), nausea (4%), upper abdominal pain (3%), vomiting (3%)

Hematologic & oncologic: Lymphadenopathy (1%)

Hepatic: Abnormal hepatic function tests (1%)

Infection: Infection (3%; including bacterial infection, fungal infection, viral infection)

Local: Infusion-site pain (2%)

Nervous system: Dizziness (1%), headache (5%)

Neuromuscular & skeletal: Back pain (2%)

Respiratory: Dyspnea (1%)

<1%:

Cardiovascular: Venous thrombosis (iliac)

Dermatologic: Allergic dermatitis, night sweats, toxic epidermal necrolysis

Endocrine & metabolic: Hyperglycemia

Gastrointestinal: Hiccups, stomatitis

Genitourinary: Proteinuria

Hypersensitivity: Anaphylaxis, serum sickness

Infection: Herpes simplex infection

Nervous system: Agitation, asthenia, encephalitis, malaise, paresthesia, seizure

Neuromuscular & skeletal: Laryngospasm

Ophthalmic: Periorbital edema

Renal: Renal artery thrombosis, renal function test abnormality

Respiratory: Pleural effusion, pulmonary edema

Miscellaneous: Wound dehiscence

Postmarketing:

Cardiovascular: Deep vein thrombosis, heart failure, syncope, vasculitis

Dermatologic: Hyperhidrosis

Gastrointestinal: Abdominal pain, gastrointestinal hemorrhage, gastrointestinal perforation, mouth pain

Hematologic & oncologic: Anemia, eosinophilia, granulocytopenia, hemolysis, hemolytic anemia, neutropenia, pancytopenia, pure red cell aplasia

Hepatic: Viral hepatitis

Hypersensitivity: Cytokine release syndrome, infusion-related reaction

Infection: Opportunistic infection, sepsis

Local: Infusion-site reaction (erythema, swelling)

Nervous system: Confusion, disorientation, pain, tremor

Neuromuscular & skeletal: Dyskinesia, limb pain, muscle rigidity, myalgia

Renal: Flank pain, nephrotoxicity (including acute kidney injury, kidney enlargement, kidney rupture)

Respiratory: Apnea, cough, epistaxis, oropharyngeal pain

Contraindications

History of anaphylactic reaction during prior administration of antithymocyte globulin (equine) or any other equine gamma globulin preparation.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to antithymocyte globulin (equine) or any components of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: Anaphylaxis (sometimes life-threatening) has been reported; generalized rash, dyspnea, hypotension, and tachycardia may be signs of anaphylactic reaction. Have epinephrine and emergency equipment available for management of acute allergic reaction. Skin testing is recommended prior to administration of the initial antithymocyte globulin (ATG) dose. A positive skin test is suggestive of clinical hypersensitivity and an increased risk for systemic allergic reactions (including anaphylaxis) with IV ATG infusion, although anaphylaxis may occur in patients who display negative skin tests. If a positive skin test occurs, strongly consider alternative forms of therapy. Skin testing is not predictive for delayed hypersensitivity reactions such as serum sickness.

• Cytokine release syndrome: Cytokine release syndrome (sometimes fatal) has been reported. Symptoms may include chest pain, fever, chills, dyspnea, tachypnea, edema, headache, and hypotension.

• Hematologic toxicity: Thrombocytopenia and neutropenia may occur; consider platelet transfusion support in patients developing thrombocytopenia. Discontinue if severe and unremitting neutropenia or thrombocytopenia occur.

• Hepatic function: Abnormal hepatic function tests have been observed in patients with aplastic anemia and other hematologic disorders receiving ATG.

• Infection: Opportunistic infections (eg, bacterial, fungal, and viral) and sepsis have been reported due to immunosuppressant effect. An increased risk of viral reactivation (eg, cytomegalovirus, Epstein-Barr virus, herpes simplex virus) has been reported.

• Infusion reactions: Serious infusion-related reactions (eg, dyspnea, hypotension, generalized rash, tachycardia) have been reported.

• Kidney function: Abnormal kidney function tests have been observed in patients with aplastic anemia and other hematologic disorders receiving ATG.

• Serum sickness: Serum sickness, a delayed hypersensitivity/immune reaction, has occurred with use. Symptoms may include arthralgia, chills, fever, rash, and pain.

Concurrent drug therapy issues:

• Immunizations: Live viral vaccines may not replicate and antibody response may be reduced if administered during ATG treatment or may interfere with ATG treatment. Patients should not be immunized with attenuated live viral vaccines prior to planned ATG treatment, during, and after treatment.

Other warnings/precautions:

• Disease transmission: ATG (equine) is a product of equine and human plasma; may have a risk of transmitting disease, including viruses and Creutzfeldt-Jakob disease. Report any suspected infections to the manufacturer at 1-800-438-1985.

• Potency: Product potency and activity may vary from lot to lot.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Atgam: 50 mg/mL (5 mL) [thimerosal free]

Generic Equivalent Available: US

No

Pricing: US

Solution (Atgam Intravenous)

50 mg/mL (per mL): $1,156.87

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Atgam: 50 mg/mL (5 mL)

Administration: Adult

IV: For IV use only. Infuse over at least 4 hours through a 0.2 to 1 micron inline filter. Allow solution to reach room temperature prior to infusion. Infusion must be completed with 24 hours of preparation. Administration through a central line is recommended; high flow veins are preferred to reduce phlebitis (infuse into vascular shunt, arterial venous fistula, or high-flow central vein). May cause vein irritation (chemical phlebitis) if administered peripherally (peripheral administration is not recommended).

Monitor closely throughout the infusion and for at least 24 hours after the infusion for anaphylaxis. Appropriate resuscitative equipment should be nearby during administration. May require premedication with an antipyretic, antihistamine, and/or a corticosteroid to prevent reactions. Discontinue infusion for anaphylaxis or respiratory distress. Administer epinephrine, corticosteroids, antihistamines, and/or antipyretics as indicated to manage reactions.

Due to possible infusion-related reactions, it may be preferable to avoid initiating treatment late in the day or on weekends; consider withholding beta-blockers prior to administration to avoid suppressing compensatory responses to anaphylaxis (Ref).

Administration: Pediatric

Note: Consider premedication with antihistamines and/or antipyretics prior to start of infusion. Initiate infusion in a health care setting that includes cardiopulmonary monitoring and can provide resuscitation if necessary.

IV: Infuse dose over at least 4 hours through a 0.2 to 1 micron in-line filter. May need to slow rate of infusion if patient experiences fever or chills during infusion (Ref). Allow solution to reach room temperature prior to infusion. Infusion must be completed with 24 hours of preparation. May cause vein irritation (chemical phlebitis) if administered peripherally; infuse into a vascular shunt, arterial venous fistula, or high-flow central vein. Any severe systemic reaction to the skin test, such as generalized rash, tachycardia, dyspnea, hypotension, or anaphylaxis, should preclude further therapy. Monitor closely throughout the infusion and for at least 24 hours after the infusion for anaphylaxis. Treat infusion-associated reactions as indicated (eg, antipyretic, antihistamine).

Use: Labeled Indications

Aplastic anemia, moderate to severe: Treatment of moderate-to-severe aplastic anemia in patients not considered suitable candidates for bone marrow transplantation.

Limitations of use: The usefulness of antithymocyte globulin (equine) has not been demonstrated in patients with aplastic anemia who are suitable candidates for transplantation, or in aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, Fanconi syndrome, or in patients with known prior treatment with myelotoxic agents or radiation therapy.

Kidney transplantation: Management of allograft rejection in kidney transplantation.

Use: Off-Label: Adult

Graft-versus-host disease, acute, treatment; Kidney transplant, induction therapy; Lung transplant (induction therapy); Myelodysplastic syndromes, refractory, lower-risk disease

Medication Safety Issues
Sound-alike/look-alike issues:

Antithymocyte globulin equine (Atgam) may be confused with antithymocyte globulin rabbit (Thymoglobulin)

Atgam may be confused with Ativan

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (immunosuppressant agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care and Long-Term Care Settings).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Anti-CD20 B-Cell Depleting Therapies: May increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of anti-CD20 B-cell depleting therapy is reduced. Anti-CD20 B-Cell Depleting Therapies may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Belatacept: Antithymocyte Globulin (Equine) may increase adverse/toxic effects of Belatacept. Specifically, the risk for venous thrombosis of the renal allograft may be increased. Belatacept may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Management: A 12-hour interval between administration of these 2 agents is suggested if used concomitantly. Monitor for venous thrombosis of the renal allograft, infections, and if the belatacept dose is reduced, monitor for unmasking of antithymocyte reactions. Risk D: Consider Therapy Modification

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

Corticosteroids (Systemic): May increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of systemic corticosteroid is reduced. Corticosteroids (Systemic) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Dinutuximab Beta: Immune Globulins may decrease therapeutic effects of Dinutuximab Beta. Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Immunosuppressants (Cytotoxic Chemotherapy): May increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Immunosuppressants (Miscellaneous Oncologic Agents): May increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Immunosuppressants (Therapeutic Immunosuppressant Agents): May increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Methotrexate: May increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of methotrexate is reduced. Methotrexate may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Patients who could become pregnant and patients with partners who could become pregnant should use effective contraception during therapy and for at least 10 weeks after the last dose of antithymocyte globulin (equine).

Pregnancy Considerations

Antithymocyte globulin (equine) is a purified immunoglobulin G. Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Outcome data related to the use of antithymocyte globulin (equine) during pregnancy are limited (Aitchison 1989; Miller 1995; Pajor 1992). Antithymocyte globulin (equine) is not recommended for the treatment of aplastic anemia in pregnancy (Killick 2016).

The Transplant Pregnancy Registry International (TPR) is a registry that follows pregnancies that occur in maternal transplant recipients or those fathered by male transplant recipients. The TPR encourages reporting of pregnancies following solid organ transplant by contacting them at 1-877-955-6877 or https://www.transplantpregnancyregistry.org.

Breastfeeding Considerations

It is not known if antithymocyte globulin (equine) is present in breast milk.

Antithymocyte globulin (equine) is a purified immunoglobulin G. Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made to discontinue nursing or to discontinue the drug, considering the importance of treatment to the mother.

Monitoring Parameters

Complete blood count with differential and platelet count. Hepatic and renal function tests as clinically indicated. Monitor vital signs during administration; monitor for signs/symptoms of anaphylaxis during infusion and for at least 24 hours after the infusion; monitor for signs/symptoms of cytokine release syndrome; monitor for infusion reactions; monitor for signs/symptoms of infection; monitor for signs/symptoms of serum sickness.

Solid organ transplant: Absolute CD3 count (cells/µL) monitoring and CD3 based-dosing has been considered in renal and heart transplant recipients. It may be beneficial in certain patient populations but is not routinely recommended or utilized. Dose adjustments have been recommended based on the CD3 count (Krasinska 2002).

Mechanism of Action

Immunosuppressant involved in the elimination of antigen-reactive T lymphocytes (killer cells) in peripheral blood or alteration in the function of T-lymphocytes, which are involved in humoral immunity and partly in cell-mediated immunity; induces complete or partial hematologic response in aplastic anemia

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Poor into lymphoid tissues; binds to circulating lymphocytes, granulocytes, platelets, bone marrow cells

Half-life elimination: 5.7 ± 3 days

Excretion: Urine (~1%)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Atgam;
  • (AR) Argentina: Atgam;
  • (AT) Austria: Atgam;
  • (AU) Australia: Atgam;
  • (BE) Belgium: Atgam;
  • (BG) Bulgaria: Atgam;
  • (CH) Switzerland: Atgam;
  • (CL) Chile: Atgam;
  • (DE) Germany: Atgam;
  • (DO) Dominican Republic: Atgam;
  • (EE) Estonia: Atgam;
  • (ES) Spain: Atgam;
  • (FI) Finland: Atgam;
  • (FR) France: Atgam;
  • (GB) United Kingdom: Atgam;
  • (HK) Hong Kong: Atgam;
  • (IN) India: Atgam;
  • (JP) Japan: Atgam;
  • (KR) Korea, Republic of: Atgam;
  • (LT) Lithuania: Atgam;
  • (LV) Latvia: Atgam;
  • (MX) Mexico: Atgam;
  • (MY) Malaysia: Atgam;
  • (NL) Netherlands: Atgam;
  • (NO) Norway: Atgam;
  • (NZ) New Zealand: Atgam;
  • (PL) Poland: Atgam;
  • (PR) Puerto Rico: Atgam;
  • (PT) Portugal: Atgam;
  • (QA) Qatar: Atgam;
  • (RO) Romania: Atgam;
  • (RU) Russian Federation: Atgam;
  • (SE) Sweden: Atgam;
  • (SG) Singapore: Atgam;
  • (SI) Slovenia: Atgam;
  • (TN) Tunisia: Atgam;
  • (TR) Turkey: Equagam;
  • (TW) Taiwan: Atgam;
  • (UA) Ukraine: Atgam;
  • (ZA) South Africa: Atgam
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  3. Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med. 2021;16(8):591-593. doi:10.1089/bfm.2021.0110 [PubMed 33956488]
  4. Atgam (lymphocyte immune globulin, antithymocyte globulin [equine]) [prescribing information]. New York, NY: Pharmacia & Upjohn Co; August 2021.
  5. Atgam (lymphocyte immune globulin, antithymocyte globulin [equine]) [prescribing information]. New York, NY: Pharmacia & Upjohn Co; September 2023.
  6. Atgam (lymphocyte immune globulin, antithymocyte globulin [equine]) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada ULC; May 2022.
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  27. Refer to manufacturer’s labeling.
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