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.
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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.