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Efficacy Setting the Standard of Care in AFD.

AFD=acquired fibrinogen deficiency,
also known as acquired hypofibrinogenemia

Fibrinogen Supplementation: Fibryga vs. Cryoprecipitate

FIBRES Study: A prospective, multicenter, randomized, controlled, single-blinded study conducted in adult cardiac surgical patients experiencing clinically significant bleeding and hypofibrinogenemia.1

Primary Efficacy Outcome: Blood components (red blood cells, platelets, plasma) administered during 24 hours post bypass. A 2-sample, 1-sided test for the ratio of the mean number of units was conducted to evaluate non-inferiority (threshold for non-inferiority ratio, <1.2).1

Total Number of Allogeneic Blood Product Units Transfused Within 24 Hours After Termination of CPB

In FIBRES, fibryga demonstrated non-inferiority to cryoprecipitate

Non-inferiority of fibryga to cryoprecipitate

CPB=cardiopulmonary bypass; SD=standard deviation; IQR=interquartile range; ABP=allogeneic blood product; CI=confidence interval

Based on interim analysis for FIBRES study.

*Using ordinary Poisson regression, the 99.742% upper CI limit was calculated to be 1.04, below the pre-specified 1.20 non-inferiority margin, demonstrating fibryga was non-inferior to cryoprecipitate (p<0.0001, compared to the pre-specified alpha level of 0.00258)

View Jama Publication

Key Outcomes

Proven Efficacy

Fibryga was non-inferior to cryoprecipitate with regard to number of blood components transfused in a 24-hour period post bypass surgery.1

Favorable Safety Profile

Treatment-emergent adverse event (TEAE) profiles were found to be similar between fibryga and cryoprecipitate, with no significant difference observed.1

IN perioperative SETTINGS FIBRYGA was available faster than cryo2

FORMA-05 Study: a prospective, randomized, controlled, open-label phase 2 study that evaluated the hemostatic efficacy and safety of fibryga vs cryoprecipitate in bleeding patients with acquired fibrinogen deficiency undergoing cytoreductive surgery (CRS) for pseudomyxoma peritonei (PMP).2

The primary endpoint was a composite of intraoperative and postoperative efficacy, graded using objective 4‐point scales and adjudicated by an independent committee.2

Key Conclusions: A post-hoc analysis showed that fibryga was non-inferior to cryoprecipitate.

Primary Efficacy Outcome: 100% of patients who received fibrinogen supplementation with either fibryga (95% CI: 83.9-100.0, n = 21) or cryoprecipitate (95% CI: 84.6-100.0, n = 22) achieved the primary endpoint of overall hemostatic treatment success.2

Fibryga Was Delivered To The OR
~45 Minutes Earlier Than Cryo2

Fibryga Was Administered
~24 Minutes Earlier Than Cryo2

Did you know?

When compared to cryo, Fibryga Expedites Fibrinogen Replenishment.2,3

In clinical studies, fibryga provided a more rapid replenishment of plasma fibrinogen levels and improved blood clot firmness.2

Connect with a RepSafety 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 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.