Bleeding disorders:

Indications for FIBRYGA:

Acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Adults and Children:

See full labeling. Give by slow IV inj at rate not exceeding 5mL/min. Individualize. Target fibrinogen plasma level: 100mg/dL (minor bleeding); 150mg/dL (major bleeding). Calculate dose when baseline fibrinogen level is known (0–<12yrs): Dose (mg/kg body wt) = [Target level (mg/dL) – measured level (mg/dL)] / 1.4 (mg/dL per mg/kg body wt); (≥12yrs): Dose (mg/kg body wt) = [Target level (mg/dL) – measured level (mg/dL)] / 1.8 (mg/dL per mg/kg body wt). When baseline fibrinogen level is not known: 70mg/kg. Monitor fibrinogen level during therapy. Give additional infusions if fibrinogen level is below the accepted lower limit (80mg/dL [minor bleeding]; 130mg/dL [major bleeding]) until hemostasis is achieved.

FIBRYGA Warnings/Precautions:

Not for use in dysfibrinogenemia. Discontinue immediately if signs of hypersensitivity reactions or symptoms of allergic reactions occur. Risk for thrombosis (monitor). Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Pregnancy. Nursing mothers.

FIBRYGA Classification:

Hemostatic.

Adverse Reactions:

Nausea, vomiting, pyrexia, thrombocytosis; thromboembolic events, hypersensitivity or allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Single-dose bottle—1 (w. Octajet transfer device and filter)