Interferon Gamma-1b (Actimmune)

Actimmune (interferon gamma‑1b) is covered only for the FDA‑approved indications—reducing serious infections in chronic granulomatous disease and delaying progression of severe malignant osteopetrosis—and is excluded for patients with known hypersensitivity to interferon gamma or E. coli‑derived components and for oncology off‑label uses (no compendial off‑label indications). Approval (up to 12 months) requires documented diagnosis and absence of hypersensitivity and adherence to monitoring/safety requirements including hematologic (neutropenia/thrombocytopenia), hepatic (monthly LFTs in <1‑year‑olds; hold/reduce for severe AST/ALT elevations), renal, and neurologic/seizure monitoring, with dose modification/discontinuation for specified adverse events.

"To reduce the frequency and severity of serious infections associated with chronic granulomatous disease"

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