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 not indicated for dysfibrinogenemia.
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
