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HomeEfficacyEfficacyAplastic AnemiaRenal Allograft RejectionSafetyDosing & Administration
Prescribing Information, including BOXED WARNINGIndications
Dosing & AdministrationDosing information in moderate to severe aplastic anemia1The recommended dosage is 10 mg/kg to 20 mg/kg daily intravenously for 8 to 14 days. Additional alternate-day therapy up to a total of 21 doses may be given.Dosing information in renal allograft rejection1The recommended dose is 10 mg/kg to 15 mg/kg daily intravenously for 14 days. Additional alternate-day therapy up to a total of 21 doses may be given.Administration guidelines1
  • Patients receiving ATGAM must be monitored in a facility equipped and staffed with adequate laboratory and supportive medical resources
     
  • Administer ATGAM intravenously and use with concomitant immunosuppressants
     
  • Skin testing to identify patients at risk of systemic anaphylaxis is strongly recommended
 Steps of ATGAM IV infusion1 ATGAM must be diluted for IV infusion Do not dilute ATGAM in Dextrose Injection, USP The mixture must be gently rotated or swirled to mix and allowed to reach room temperature Do not exceed a concentration of 4 mg of ATGAM per mL ATGAM must be infused over a period of 4 hours or more. The diluted solution must be infused within 24 hours (including the infusion time)
  • Anaphylaxis has been reported with the use of ATGAM. ATGAM 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
     
  • While patients are receiving ATGAM via IV infusion, the patient should be closely monitored for signs of allergic reactions, and epinephrine and emergency equipment must be readily available

IV=intravenous.

Reference:ATGAM [prescribing information]. New York, NY: Pfizer Inc., May 2023. Explore ATGAM Efficacy Efficacy Loading Learn About ATGAM Safety Safety Loading ATGAM Ordering and Availability Information
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ATGAM® (lymphocyte immune globulin, anti-thymocyte globulin [equine]) INDICATIONS

ATGAM is indicated for:
 
  • Management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection ATGAM increases the frequency of resolution of the acute rejection episode.
  • Treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation.

LIMITATIONS OF USE

The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, Fanconi's syndrome, or in patients known to have been exposed to myelotoxic agents or radiation.

Please see full Prescribing Information, including BOXED WARNING.
IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS

Anaphylaxis has been reported with the use of ATGAM. ATGAM 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.

Contraindications
Do not administer ATGAM to a patient who has had an anaphylactic reaction during prior administration of ATGAM or any other equine gamma globulin preparation.

Warnings and Precautions

Anaphylaxis: Discontinue ATGAM if anaphylaxis occurs.
  • Skin testing: To identify those at greatest risk, skin testing before treatment is strongly recommended.
  • Monitoring and Management of Anaphylaxis: Administer ATGAM in a healthcare facility where a physician familiar with the treatment of potentially life-threatening allergic reactions is in attendance. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion of ATGAM.
Cytokine Release Syndrome: Monitor patients for signs and symptoms of cytokine release syndrome and manage according to relevant clinical guidelines. 

Infusion-Associated Reactions: Monitor patients for signs and symptoms of infusion-associated reactions and manage according to relevant clinical guidelines.


Serum Sickness: Monitor patients for signs and symptoms of serum sickness and manage according to relevant clinical guidelines.
 

Transmissible Infectious Agents: Because ATGAM is made from equine and human blood components, it may carry a risk of transmitting infectious agents. Report any infection suspected to have been transmitted by this product to Pfizer Inc. at 1-800-438-1985. 

  • Infections: Monitor patients carefully for concurrent infection, including cytomegalovirus, Epstein-Barr virus, and herpes simplex virus infection.

  • Immunizations: Do not administer live vaccines to patients about to receive, receiving, or after treatment with ATGAM.
  • Thrombocytopenia and Neutropenia: If thrombocytopenia occurs, consider platelet transfusions to maintain platelets at clinically acceptable levels. Consider discontinuing ATGAM if severe and unremitting thrombocytopenia or neutropenia occurs.

Hepatic and Renal Function Tests: Monitor liver and renal functions as clinically indicated and manage according to relevant clinical guidelines. 
 

Adverse Reactions

The most clinically significant adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests.

Drug Interactions
A potential pharmacodynamic interaction concerns the concomitant administration of ATGAM with corticosteroids and other immunosuppressants, which are associated with an increased susceptibility to bacterial, viral, and fungal infections. The severity of the infections such as septicemia may be masked, and their clinical presentations may be atypical.

Monitor patients receiving ATGAM and immunosuppressive agents such as corticosteroids when the dose of corticosteroids and other immunosuppressants is being reduced, since this adjustment of dose may result in reduced immunosuppression and lead to development of previously masked reactions to ATGAM.

Use in Specific Populations

Pregnancy: Use only if the potential benefit to the mother justifies the potential risk.

Lactation: Discontinue breast-feeding during treatment with ATGAM or discontinue ATGAM treatment.

Contraception: Advise females of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy. Advise males with a female partner of reproductive potential to use effective contraception during treatment with ATGAM and for at least 10 weeks after cessation of therapy.

Geriatric: Start dosing at the low end of the dosing range.

Please see full Prescribing Information, including BOXED WARNING.INDICATIONSATGAM is indicated for:
  • Management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection ATGAM increases the frequency of resolution of the acute rejection episode.
  • Treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation.

LIMITATIONS OF USE

The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, Fanconi's syndrome, or in patients known to have been exposed to myelotoxic agents or radiation.Please see full Prescribing Information, including BOXED WARNING.