RiaSTAP®
Freeze-dried fibrinogen (factor I) concentrate
RiaSTAP
® (fibrinogen concentrate [human]) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (CFD), including afibrinogenemia and hypofibrinogenemia. RiaSTAP
® is not indicated for dysfibrinogenemia.
- Concentrated lyophilized protein that is easily reconstituted in minutes
- 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 and quick administration
- Virus inactivation/removal reduces risk of exposure to infectious agents
- Easily stored and access when needed, due to room temperature storage and 30-month shelf life
| NDC Number |
RiaSTAP Vial |
| 63833-891-51 |
Approximately 1 g (900 – 1300 mg) |
Important Safety Information
RiaSTAP® was approved using maximum clot firmness (MCF) as a surrogate marker likely to predict clinical benefit. Thus, the hemostatic efficacy of RiaSTAP® in acute bleeding episodes has not been established. A post-marketing study is being conducted to verify clinical endpoints.
RiaSTAP® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP® or its components.
Monitor patients for early signs of allergic 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, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The most serious adverse reactions that have been reported in subjects in clinical studies who received RiaSTAP™ are thromboembolic episodes, including myocardial infarction and pulmonary embolism, and allergic-anaphylactic reactions. The most common adverse reactions observed are allergic reactions, including chills, fever, nausea, and vomiting. Monitor patients for early signs of allergic or hypersensitivity reactions and if necessary, discontinue administration.
Please see
Full Prescribing Information.
RiaSTAP is a trademark of CSL Behring GmbH
CUSTOMER SUPPORT 1-800-683-1288 or
Customer Services
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.
To learn more about RiaSTAP®, please visit www.RiaSTAP.com
Last Updated: 04 August 2011