Givosiran (Givlaari)

Givlaari (givosiran) is covered only for adults with FDA‑approved acute hepatic porphyria (AHP) and is excluded for non‑AHP indications. Approval requires age ≥18, documented AHP confirmed by both clinical features and elevated urinary ALA or PBG, at least one qualifying porphyria attack in the past 6 months requiring hospitalization/urgent care or IV hemin, prescription by or in consultation with a gastroenterologist/hepatologist/AHP specialist, and dosing consistent with 2.5 mg/kg subcutaneously once monthly.

"Givlaari is indicated for the treatment of adults with acute hepatic porphyria (AHP)."

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