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Safety Demonstrated Safety In Bleeding Patients with AFD.

AFD=acquired fibrinogen deficiency,
also known as acquired hypofibrinogenemia

Safety Profile in AFD

The FIBRES study investigated the safety of fibryga compared with cryoprecipitate (cryo) in adult patients with acquired fibrinogen deficiency (AFD) who were experiencing clinically significant bleeding and hypofibrinogenemia after cardiac surgery.1

Adverse Reactionsfibryga Patients
(N=372) n (%)		 Cryo Patients
(N=363) n (%)
Treatment-Emergent Adverse Events (TEAEs)*248 (66.7%)264 (72.7%)
Serious Adverse Events (SAEs)117 (31.5%)126 (34.7%)
Thromboembolic Events (Total)*,†32 (8.6%)45 (12.4%)

*Patients who experienced more than 1 event are counted only once in the total.

†The 32 patients in the FIBRYGA group experienced a total of 37 thromboembolic adverse events. The 45 patients in the cryoprecipitate group experienced a total of 50 thromboembolic adverse events.

Adverse Reactions Reported in More Than 5% of Patients Following FIBRYGA or Cryoprecipitate Administration in the FIBRES Study1

Adverse ReactionsFibryga Patients
(N=372) n (%)		 Cryo Patients
(N=363) n (%)
Cardiac disorders
Atrial fibrillation108 (29.0%)122 (33.6%)
Blood & lymphatic system disorders
Anemia58 (15.6%)52 (14.3%)
Thrombocytopenia15 (4.0%) 20 (5.5%)
Psychiatric disorders
Delirium56 (15.1%) 54 (14.9%)
Renal and urinary disorders
Acute kidney injury29 (7.8%)29 (8.0%)
Renal failure19 (5.1%)19 (5.2%)
Hepatobiliary disorders
Hepatic function abnormal27 (7.3%)26 (7.2%)
Infections and infestations
Pneumonia18 (4.8%)19 (5.2%)

Demonstrated Safety Across 2 Indications1

The most serious adverse reactions that may be observed with fibryga are thromboembolic episodes and anaphylactic-type reactions.1
safety for cfd
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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.