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Fibrinogen’s Role in Coagulation

Fibrinogen (clotting factor I) is synthesized in the liver and plays a critical role in the hemostatic process. Fibrinogen promotes platelet aggregation by stimulating platelet clumping. Soluble fibrinogen also converts to insoluble fibrin, which is cross-linked to form a mesh-like network.

The cross-linked fibrin is the culmination of the coagulation cascade. The fibrin mesh traps red blood cells and platelets and eventually forms a stable blood clot.

The fibrin mesh is responsible for:

Providing tensile strength
Ensuring stability of the initially loose platelet plug
Mechanically impeding blood loss at the sites of blood vessel injury
Providing structure to the vessel wall

Depending on the severity of the deficiency, clotting could be jeopardized. A therapeutic option is to provide factor replacement therapy to treat the fibrinogen deficiency. RiaSTAP^® offers replacement therapy by effectively raising fibrinogen levels.

Next: Types of Congenital Fibrinogen Deficiency

See an interactive overview of the Coagulation Cascade.

Learn more about the Mechanism of Action of RiaSTAP^®.

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 not indicated for dysfibrinogenemia.

RiaSTAP^® was approved using maximum clot firmness (MCF) as a surrogate marker likely to predict clinical benefit. Thus, the hemostatic efficacy of RiaSTAP^® in acute bleeding episodes has not been established. A post-marketing study is being conducted to verify clinical endpoints.

RiaSTAP^® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP^® or its components.

Monitor patients for early signs of allergic 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, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most serious adverse reactions that have been reported in subjects in clinical studies who received RiaSTAP^® are thromboembolic episodes, including myocardial infarction and pulmonary embolism, and allergic-anaphylactic reactions. The most common adverse reactions observed are allergic reactions, including chills, fever, nausea, and vomiting. Monitor patients for early signs of allergic or hypersensitivity reactions, and if necessary, discontinue administration.

Please see full Prescribing Information.

RiaSTAP^® is a trademark of CSL Behring GmbH

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.