RiaSTAP is indicated for the treatment
of acute bleeding episodes in patients with congenital fibrinogen deficiency (CFD),
including afibrinogenemia and hypofibrinogenemia.
- Concentrated lyophilized protein that is easily reconstituted
- Labeled with exact fibrinogen content to assist with coagulation management
- Demonstrated ability to effectively raise fibrinogen to within target levels
- Concentrated fibrinogen allows for low infusion volume
- Virus inactivation/removal reduces risk of exposure to infectious agents
- When stored at temperatures of 2-8°C (36-46°F), RiaSTAP is stable for the period indicated by the expiration date on the carton and vial label (up to 60 months)
- RiaSTAP is stable for 8 hours after reconstitution when stored at 20-25°C; administer within this time period
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.
