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.

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.