RECENT MAJOR CHANGES

Adverse Reactions (6, 6.1, 6.2) 10/2009

INDICATIONS AND USAGE

ADVATE is an Antihemophilic Factor (Recombinant) indicated for:

• Control and prevention of bleeding episodes in adults and children with Hemophilia A(1.1)
• Perioperative management in adults and children with hemophilia A (1.2)

DOSAGE AND ADMINISTRATION

• For intravenous use after reconstitution only (2)
• Each vial of ADVATE contains the labeled amount of recombinant Factor VIII in international units (IU) (2)
• The required dosage is determined using the following formulas:
  • Desired increment in Factor VIII concentration (IU/dL or % of normal)=[Total Dose (IU)/body weight (kg) × 2 [IU/dL]/[IU/kg]
  • OR Required Dose (IU) = body weight (kg) × Desired Factor VIII Rise (IU/dL or % of normal) × 0.5 (IU/kg per IU/dL)
• Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician (2.1, 2.2)

DOSAGE FORMS AND STRENGTHS

ADVATE is available in single use vials containing 250, 500, 1000, 1500, 2000 and 3000 IU. (3)

CONTRAINDICATIONS

Known anaphylaxis to mouse or hamster protein or other constituents of the product.. (4)

WARNINGS AND PRECAUTIONS

• Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with ADVATE should be discontinued, and appropriate treatment should be administered (5.1)
• Development of activity-neutralizing antibodies has been detected in patients receiving Factor VIII-containing products. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay that measures factor VIII inhibitor concentration should be performed. (5.3)
• Patients may develop hypersensitivity to mouse or hamster protein, which a present in trace amounts in the product. (5.2)