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Important Safety Information and Indications

CONTRAINDICATIONS: ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to ELOCTATE or other constituents of the product.

WARNINGS AND PRECAUTIONS: Hypersensitivity reactions, including anaphylaxis, are possible with ELOCTATE. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur. Formation of neutralizing antibodies (inhibitors) to Factor VIII has been reported following administration of ELOCTATE, including in previously untreated patients. Patients using ELOCTATE should be monitored for the development of Factor VIII inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained.

ADVERSE REACTIONS: The most frequently occurring adverse reactions (>0.5% of subjects) in clinical trials were arthralgia, malaise, myalgia, headache, and rash.

INDICATIONS: ELOCTATE is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease.

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