Mononine^®

Coagulation Factor IX (Human) Monoclonal Antibody Purified

• A high-purity factor IX product with a track record of over half a billion units infused since 1992 without any confirmed cases of thrombotic events or viral transmissions
• Unique three-step viral inactivation and removal process designed to protect against both lipid-enveloped and certain non-lipid-enveloped viruses
• Peel-off labels designed for patient convenience

Important Safety Information for Mononine

Coagulation Factor IX (Human), Mononine ^®, is indicated for the prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease.

Mononine is not indicated in the treatment or prophylaxis of Hemophilia A patients with inhibitors to Factor VIII.

Mononine is contraindicated in patients with known hypersensitivity to mouse protein.

The following adverse reactions may be observed after administration: headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, hives, stinging or burning at the infusion site, or other manifestations of allergic reactions, including anaphylaxis.

Mononine is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Since the use of Factor IX Complex concentrates has historically been associated with the development of thromboembolic complications, the use of Factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC).

Please see full prescribing information for Mononine.

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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.