The Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation has described recombinant factor VIII therapy in terms of three generations. Each is defined by the presence of animal or human plasma at stages in the manufacturing process.1
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.
References:
1. The National Hemophilia Foundation. MASAC Recommendations Concerning the Treatment of Hemophilia and Other Bleeding Disorders. MASAC Document #177. October 2006.
2. World Federation of Hemophilia. Hemophilia—a timeline. Available at: http://www.wfh.org/2/1/1_1_3_Link1_Timeline.htm. Accessed February, 2008.
3. RECOMBINATE Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; October 2007.
4. McCormack PL, Plosker GL. Octocog alpha, plasma/albumin-free method. Drugs. 2005;65:2613-2620.
5. ADVATE Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; July 2007.
