Baxter Receives Approval for 3000 IU Dosage Strength of ADVATE for Hemophilia A [PDF] - July 11, 2007
Baxter to Include Baxject® II in ADVATE® [Antihemophilic Factor
(Recombinant), Plasma/Albumin-Free Method] Packaging - January 30, 2007
Indications:
ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes and for perioperative management of patients with hemophilia A.
ADVATE is not indicated for the treatment of von Willebrand’s disease.
Important Safety Information:
Let your doctor know if you have had any previous allergic reactions to other factor VIII products or mouse or hamster proteins.
The most common related adverse reactions observed during the ADVATE clinical studies include: strange taste in mouth, headache, dizziness, and redness in the face.
There is a possibility that you can have an allergic reaction to ADVATE. Symptoms of an allergic reaction may include rash, hives, itching, tightness in throat or chest, difficulty breathing, feeling dizzy or light-headed, or a weak pulse. If you experience any of these symptoms, stop the infusion immediately and promptly contact your doctor.
Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of factor VIII therapy.
