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ATGAM® Warnings and Precautions (lymphocyte immune globulin, anti-thymocyte globulin [equine])


5.1 Anaphylaxis

Anaphylaxis has been reported with the use of ATGAM. Anaphylaxis is potentially life-threatening. Discontinue ATGAM if anaphylaxis occurs. Generalized rash, tachycardia, dyspnea, and hypotension can be signs of an anaphylactic reaction.

Skin Testing

To identify those at greatest risk of systemic anaphylaxis, skin testing potential recipients is strongly recommended before commencing treatment. Consult an allergist for epicutaneous (prick) and intradermal testing and interpretation. Positive skin testing to ATGAM suggests clinical hypersensitivity and increased risk of a systemic allergic reaction (including anaphylaxis) should the drug be dosed intravenously. In the event of a positive skin test, seriously consider alternative forms of therapy. The predictive value of this test has not been proven clinically, and allergic reactions such as anaphylaxis have occurred in patients whose skin tests were negative. It is important to note that skin testing does not inform risk of delayed hypersensitivity reactions such as serum sickness.

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. Have epinephrine and emergency equipment available for treatment of acute allergic symptoms, should they occur.

5.2 Cytokine Release Syndrome

Cytokine release syndrome has been reported with the use of ATGAM. Cytokine release syndrome can be fatal. Clinical signs may include fever, chills, headache, chest pain, hypotension, dyspnea, tachypnea, and edema. Monitor patients for signs and symptoms of cytokine release syndrome and manage according to relevant clinical guidelines.

5.3 Infusion-Associated Reactions

Serious infusion-associated reactions have been reported with the use of ATGAM. Clinical signs associated with infusion-associated reactions include generalized rash, tachycardia, dyspnea, and hypotension. Monitor patients for signs and symptoms of infusion-associated reactions and manage according to relevant clinical guidelines.

5.4 Serum Sickness

Serum sickness is a delayed hypersensitivity/immune reaction. Symptoms of serum sickness including rash, arthralgia, pyrexia, chills, and pain have been reported. Monitor patients for signs and symptoms of serum sickness and manage according to relevant clinical guidelines.

5.5 Transmissible Infectious Agents

Because ATGAM is made from equine and human blood components, it may carry a risk of transmitting infectious agents, e.g., viruses and the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens.

Report any infection suspected to have been transmitted by this product to Pfizer Inc. at 1-800-438-1985.

5.6 Infections

Due to the immunosuppressive effects of ATGAM, opportunistic infections (viral, bacterial and fungal) have been reported. Sepsis has also been reported. There is an increased risk of viral reactivation (e.g., cytomegalovirus [CMV], Epstein–Barr virus [EBV] infection, herpes simplex virus [HSV]). Monitor patients carefully for concurrent infection.

5.7 Immunizations

Do not administer live vaccines to patients about to receive, receiving, or after treatment with ATGAM. Concomitant administration of ATGAM with live virus vaccines carries a potential of uncontrolled viral replication in the immunosuppressed patient. There is insufficient information to fully define the extent of the risk, or the period of time during which the risk exists. If administered, live viruses may interfere with ATGAM treatment.

5.8 Thrombocytopenia and Neutropenia

Thrombocytopenia and neutropenia have been reported with the use of ATGAM. If thrombocytopenia occurs, consider platelet transfusions to maintain platelets at clinically acceptable levels. Consider discontinuing ATGAM if severe and unremitting thrombocytopenia or neutropenia occurs.

5.9 Hepatic and Renal Function Tests

In patients with aplastic anemia and other hematologic abnormalities who have received ATGAM, abnormal test results of liver function (SGOT, SGPT, alkaline phosphatase) and renal function (serum creatinine) have been observed. Monitor liver and renal functions as clinically indicated and manage according to relevant clinical guidelines.

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