RiaSTAP is a lyophilized fibrinogen concentrate (coagulation factor I), made from human plasma, and administered intravenously. It has been used for years in several European countries under the name Haemocomplettan® P.

In patients with CFD, administered RiaSTAP replaces absent or low fibrinogen. As such, RiaSTAP serves as a physiological substrate of thrombin (factor IIa), which converts soluble fibrinogen to insoluble fibrin. Under the influence of factor XIIIa, fibrin strands are cross-linked to provide strength and stability to the blood clot—fulfilling an essential need for clot formation in patients with fibrinogen deficiency.

Important Safety Information

RiaSTAP®, Fibrinogen Concentrate (Human), is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

RiaSTAP is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.

Monitor patients for early signs of anaphylaxis or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving RiaSTAP; weigh the benefits of administration versus the risks of thrombosis.

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

The most serious adverse reactions observed are thrombotic episodes (pulmonary embolism, myocardial infarction, deep vein thrombosis) and anaphylactic reactions. The most common adverse reactions observed in clinical studies (frequency >1%) were fever and headache.

Please see full prescribing information for RiaSTAP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.