Fibryga Generic Name & Formulations
Legal Class
Rx
General Description
Fibrinogen concentrate (human) approx. 1g; per bottle; lyophilized pwd for IV inj after reconstitution; preservative-free.
Pharmacological Class
Hemostatic.
How Supplied
Single-dose bottle—1 (w. Octajet transfer device and filter)
Manufacturer
Generic Availability
NO
Fibryga Indications
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
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
Not Applicable
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
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