Congenital fibrinogen deficiency (CFD) can result in bleeding complications, with the severity of symptoms coinciding with the extent of the fibrinogen deficiency.

According to the World Federation of Hemophilia, common types of bleeding episodes in patients with CFD include:

  • Excessive bleeding with trauma or surgery
  • Impaired wound healing after surgery
  • Bruising
  • Hemarthrosis
  • Hematoma
  • Epistaxis
  • Oral mucosal bleeding
  • Menorrhagia
  • Gastrointestinal bleeding

Bleeding complications that occur only rarely but can be life-threatening include:

  • Intracranial hemorrhage
  • Splenic rupture
  • Miscarriage

Patients with afibrinogenemia are most likely to suffer from severe, potentially life-threatening bleeding episodes. In fact, intracranial hemorrhage during infancy or childhood is a major cause of death in these patients.

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.