Why Fibryga?
First & Only FDA‑Approved FC for AFD.¹

AFD=acquired fibrinogen deficiency,
also known as acquired hypofibrinogenemia; FC=fibrinogen concentrate.

Open. Mix. Clot.
All Within Minutes.¹

Fibrinogen replacement needs arise fast

Fibryga can be reconstituted within 5–10 minutes for rapid hemostasis in emergency and perioperative settings.^1-6Dosing flexibility with ~1 g or ~2 g vial options¹

Consistent & Precise Dosing in Every Vial¹

Only fibryga provides a consistent and precise amount of purified fibrinogen in a low volume infusion—in a ~1 g/50 mL or ~2 g/100 mL sterile water solution.¹

No Refrigeration Required¹

Unlike some other fibrinogen concentrates, fibryga does not require refrigeration, making it readily available at the point of care.^1,7

Fibryga Provides What's Critical for Clotting^1,6

Fibryga provides a concentrated source of fibrinogen, an essential protein for blood clotting. When administered intravenously, it increases the plasma levels of fibrinogen:^1,6

During hemostasis, fibrinogen is converted to fibrin.

Fibrin forms a mesh-like structure that stabilizes the initial platelet plug at the site of injury, trapping blood cells and other components and creating a stable and resilient blood clot.

Once the fibrin clot forms, Factor FXIIIa acts on the fibrin strands to cross-link them, ensuring the stability and durability of the clot.^1,6,8

Did you know?

In preclinical studies,

fibryga demonstrated enhanced clotting ability.^*

*Compared to other fibrinogen concentrates due to the higher amount of Factor XIII it contains.⁸

Stay Ahead of a Bleeding Crisis.^1,6

Fibryga provides a concentrated source of fibrinogen, an essential protein for blood clotting. When administered intravenously, it increases the plasma levels of fibrinogen.^1,6

Only the Fibrinogen You Need. Nothing You Don't.¹

Fibryga is made from pooled human plasma. The final product contains highly purified fibrinogen, ensuring minimal impurities and high functional activity. During its manufacturing process, fibryga undergoes viral inactivation and nanofiltration to remove and reduce viruses, particularly for hepatitis A, B, and C, HIV, and parvovirus through the following methods^1,6:

Solvent Detergent
(S/D) Treatment

Crucial for inactivating lipid-enveloped viruses, the solvent detergent method disrupts the lipid membranes of viruses, rendering them non-infectious.

Nanofiltration

Filters out both enveloped and non-enveloped viruses based on size exclusion, enhancing the safety profile by physically removing pathogens.

Fibrinogen Dose Consistency

Compared to cryo:

Fibryga offers
greater precision & minimal variability
in fibrinogen
per dose^1,9

Cryo=cryoprecipitate.

In addition to its high purity, the ratio of fibrinogen antigen to clottable protein in fibryga is almost identical to a fully native fibrinogen preparation.⁶

Connect with a Rep Efficacy Details

Indications & Important Safety Information for Fibryga, Fibrinogen (Human)

Indications and Usage

Fibryga is a human fibrinogen concentrate indicated for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency and in treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Fibryga is not indicated for dysfibrinogenemia.

Contraindications

Fibryga is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to fibryga or its components (Sodium Citrate Dihydrate; Glycine; L-Arginine Hydrochloride).

Warnings and Precautions

Monitor patients for early signs of hypersensitivity or allergic reactions. If necessary, discontinue administration and institute appropriate treatment.

Thrombotic events have been reported in patients receiving fibryga. Treatment with human fibrinogen concentrate in congenital fibrinogen deficiency has been associated with thrombosis at target plasma fibrinogen levels that were below 150 mg/dL. The thrombotic risks may be greater when the target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of administration versus the risks of thrombosis.

Fibryga is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Adverse Reactions

The most serious adverse reactions observed with fibryga are thromboembolic episodes and anaphylactic-type reactions.

The most common adverse reactions observed in clinical studies with fibryga in acquired fibrinogen deficiency (>5% of patients) were abnormal hepatic function, acute kidney injury, anemia, atrial fibrillation, delirium and renal failure.

The most common adverse reactions observed in clinical studies with fibryga in congenital fibrinogen deficiency (>5% of patients) were nausea, vomiting, pyrexia (fever) and thrombocytosis.

Please see fibryga full Prescribing Information.

To report suspected adverse reactions, contact Octapharma USA, Inc. at 1-866-766-4860 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References