In a multicenter, open-label, prospective, randomized, 2-arm, controlled postmarketing clinical study of the relative efficacy of ADVATE [Antihemophilic Factor (Recombinant)] use in 2 prophylactic treatment regimens compared to that of on-demand treatment, 53 previously treated patients (PTPs) with severe to moderately severe hemophilia A (FVIII level <2 IU/dL) were analyzed in the per-protocol group. Subjects were initially treated for 6 months of on-demand therapy and then randomized to 12 months of either a standard prophylaxis regimen (20-40 IU/kg every 48 hours) or a pharmacokinetic-driven prophylaxis regimen (20-80 IU/kg every 72 hours).1
ABRs for the two prophylaxis regimens were comparable.1
Prophylaxis with ADVATE reduced bleeds in the clinical study:
Per-Protocol: subjects who had >90% of the predicted number of infusions and no major protocol deviations.3
IQR=Interquartile range; the range of values of the variable in a statistical distribution that lies between the upper and lower quartiles.6
Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.
Side effects that have been reported with ADVATE include: cough, sore throat, abdominal pain, diarrhea, nausea/vomiting, headache, fever, dizziness, hot flashes, chills, sweating, joint swelling/aching, itching, hematoma, swelling of legs, runny nose/congestion, and rash.
ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called "classic" hemophilia).
ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A.
Your healthcare provider may give you ADVATE when you have surgery.
ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).
ADVATE is not used to treat von Willebrand disease.
You should not use ADVATE if you:
Tell your healthcare provider if you are pregnant or breastfeeding because ADVATE may not be right for you.
You should tell your healthcare provider if you:
Your body may form inhibitors to factor VIII. An inhibitor is part of the body's normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.
You can have an allergic reaction to ADVATE.
Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash.
Tell your healthcare provider about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Click here for ADVATE full Prescribing Information.