• Bleeding disorders

Fibryga Generic Name & Formulations

General Description

Fibrinogen concentrate (human) approx. 1g; per bottle; lyophilized pwd for IV inj after reconstitution; preservative-free.

Pharmacological Class


How Supplied

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


Generic Availability


Fibryga Indications


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

Fibryga Dosage and Administration

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 Contraindications

Not Applicable

Fibryga Boxed Warnings

Not Applicable

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 Pharmacokinetics

See Literature

Fibryga Interactions

Fibryga Adverse Reactions

Adverse Reactions

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

Fibryga Clinical Trials

See Literature

Fibryga Note

Not Applicable

Fibryga Patient Counseling

See Literature