RiaSTAP® (fibrinogen concentrate [human]) Fibryga® (fibrinogen concentrate [human])

Covers RiaSTAP only for treatment of acute bleeding in congenital fibrinogen deficiency (afibrinogenemia/hypofibrinogenemia) and covers Fibryga for both fibrinogen supplementation in bleeding with acquired fibrinogen deficiency and treatment of acute bleeding in congenital fibrinogen deficiency; non‑FDA indications are not authorized. Approval is IV for up to 1 month and requires documentation of diagnosis and bleeding event, patient age and weight, measured and target fibrinogen levels (use 70 mg/kg if level unknown), and adherence to age-/indication‑specific dosing formulas and referenced safety criteria (RiaSTAP: dose=(target−measured)/1.7 mg/kg; Fibryga: dose=(target−measured)/1.8 mg/kg for ≥12 years, with specified fixed or mg/kg dosing for acquired deficiency).

"RiaSTAP is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia."