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Selected Important Safety Information

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins.

Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment.

Indications and Usage

Novoeight® (Antihemophilic Factor [Recombinant]) is indicated for use in adults and children with hemophilia A for control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Novoeight® is not indicated for the treatment of von Willebrand disease.
 

Important Safety Information

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins.

Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment.

Development of activity-neutralizing antibodies (inhibitors) may occur.  If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration.

The most frequently reported adverse reactions (≥0.5%) were injection site reactions, increased hepatic enzymes, and pyrexia.


Please click here for Novoeight® Prescribing Information.