Immune Globulin Intramuscular Injection (GamaSTAN)

Covered: intramuscular GamaSTAN S/D for FDA‑approved post‑exposure prophylaxis (hepatitis A if exposed <14 days and not clinically ill, measles if exposed <6 days and susceptible/high‑risk, varicella only when VZIG is unavailable, and rubella in susceptible pregnant women who will not consider abortion) and compendial pre‑exposure hepatitis A when vaccine is unavailable or contraindicated; not indicated outside these timing windows or for persons with clinical hepatitis A. Key requirements: approval limited to a single IM dose, requires documentation of exposure/date/immunity/vaccine availability or contraindication and pregnancy status/decision as applicable, clinical justification if VZIG/IVIG alternatives are available, and safety criteria (no anti‑IgA antibodies or history of IgA‑related hypersensitivity, no severe thrombocytopenia or coagulopathy); do not administer intravenously.

"Prophylaxis following exposure to hepatitis A (greatest value when given before or soon after exposure). Note: not indicated in persons with clinical manifestations of hepatitis A or in those expos..."