GamaSTAN S/D IMPORTANT SAFETY INFORMATION
GamaSTAN S/D should not be given to persons with isolated immunoglobulin A (IgA) deficiency. Such persons have the potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.
GamaSTAN S/D should not be administered to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
GamaSTAN S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.
Local pain and tenderness at the injection site, urticaria, and angioedema may occur. Anaphylactic reactions, although rare, have been reported following the injection of human immunoglobulin preparations. Anaphylaxis is more likely to occur if GamaSTAN S/D is given intravenously; therefore, GamaSTAN S/D must be administered only intramuscularly.
Administration of live virus vaccines (eg, MMR) should be deferred until approximately 3 months after Immune Globulin (Human) administration.
GamaSTAN S/D is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.
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