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 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.
