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 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 human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
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.
Indications
RIASTAP is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Please see full prescribing information for RiaSTAP.
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
