Treatment of Congenital Fibrinogen Deficiency

Congenital fibrinogen deficiency is typically treated with replacement therapy. Historical treatment options have included fresh frozen plasma (FFP), 24-hour plasma, or cryoprecipitate, with cryoprecipitate being the most widely used. These products have several disadvantages:

  • They do not go through a virus inactivation/removal process.
  • They contain unnecessary proteins, increasing the risk of allergic reactions or adverse events.1
  • They must be thawed, prolonging time before infusion.

RiaSTAP is the first fibrinogen concentrate available in the US.

RiaSTAP is a fibrinogen concentrate that has undergone specific virus inactivation/removal to reduce the risk of exposure to infectious agents.

  1. Manco-Johnson MJ, DiMichele D, Castaman G, et al. for the Fibrinogen Concentrate Study Group. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost. 2009; 7:2064-2069.

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.