There is a chance of developing antibodies, called inhibitors, to factor VIII when you introduce factor into your body. This is a risk with all factor therapies, including ADVATE. Studies of previously treated patients (PTPs) have shown a low rate of inhibitors with ADVATE.1,3
"Times are different now, and recombinant therapies, such as ADVATE, have made great improvements." – Dawn
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* The 95% confidence interval for developing an inhibitor in PTPs (≤ 2% factor VIII) was 0.03%-2.91% based on completed study analysis.3
† Patients with ≥150 factor VIII exposure days.
‡ Some patients participated in more than one study.
§ Patients with ≥50 factor VIII exposure days.
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 formation of inhibitors has been observed with all factor VIII products, including ADVATE.
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.
