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Types of Congenital Fibrinogen Deficiency

Congenital fibrinogen deficiency (CFD) can be characterized as either a quantitative or qualitative deficiency. Both forms of the disease impair the clotting ability of the coagulation cascade and can result in uncontrolled bleeding.

Of the three types of CFD, afibrinogenemia and hypofibrinogenemia are quantitative deficiencies, whereas dysfibrinogenemia* is a qualitative deficiency.

*RiaSTAP^® is not indicated to treat dysfibrinogenemia.

Types of Congenital Fibrinogen Deficiency
Type	Description
Afibrinogenemia (quantitative deficiency)	Quantitative deficiency characterized by a complete absence or extremely low levels of fibrinogen (<20 mg/dL) 1-2 cases per million in the general population Severe and may be life-threatening Rarely, miscarriage may occur
Hypofibrinogenemia (quantitative deficiency)	Quantitative deficiency characterized by abnormally low fibrinogen levels (20 to 80 mg/dL) Number of patients affected is currently unknown bleeding episodes, but usually mild Rarely, miscarriage can occur
Dysfibrinogenemia (qualitative deficiency) RiaSTAP^® is not indicated to treat dysfibrinogenemia.	Qualitative deficiency in which individuals have normal levels of dysfunctional fibrinogen (200 to 450 mg/dL) Approximately 300 cases worldwide Asymptomatic in 50% of patients Rarely, miscarriage may occur

Next: Symptoms of CFD

Learn about Treatment of Congenital Fibrinogen Deficiency.

Learn more About RiaSTAP^® to treat CFD.

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

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.