Side effects with the use of ADVATE are uncommon, with no serious adverse events related to treatment with ADVATE reported to date. Non-serious, moderate or mild adverse events related to ADVATE include: a strange taste, itching at the infusion site, dizziness, headaches, catheter-related infections, chills, hot flashes, diarrhea, lower limb edema, sweating, nausea, pain in the upper abdomen or lower chest, prolonged bleeding after post-operative drain removal, decreased red blood cell count, joint swelling and shortness of breath. Non-serious, but severe related adverse events include: fever, headache and decreased coagulation factor VIII levels.
ABOUT ADVATE
ADVATE is a blood-clotting therapy that helps people with hemophilia A prevent and control bleeding episodes. Infused directly into the bloodstream, ADVATE works by temporarily raising the level of factor VIII in the blood, thus allowing the body's blood clotting process to function properly. Baxter expects to begin shipping ADVATE to distributors in 3-6 weeks.
ADVATE is also convenient to use because it is available in super-high potency (1500 IU/vial), with a smaller infusion volume (5mL diluent), which means shorter infusion times for patients. ADVATE comes packaged with a 10mL syringe, butterfly bandage, alcohol swab and a patient-friendly package insert.
ADVATE is processed by Baxter in its state-of-the art, multi-purpose, biotechnology facility in Neuchtel, Switzerland. This facility has the capacity to help ensure sufficient supplies of this therapy based on current and anticipated patient needs.
ADVATE is under regulatory review in Europe and Canada following Baxter's submission of a Marketing Authorization Application to the European Medicines Evaluation Agency through the European Union Centralized Procedure, and a New Drug Submission with Health Canada's Drug's Directorate in September 2002.
ABOUT HEMOPHIL
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Contact: Cindy Resman, BAXTER
847-948-2815
Porter Novelli
28-Jul-2003