Safety & EfficacyProphylaxis Information

Signficant Reduction in median
annual bleed rate (ABR)

From 44 bleeds To 1 bleed after switching from on-demand treatment to prophylaxis4,a

Clinical Trial

  • ADVATE demonstrated a significant reduction in median annual bleed rate (ABR) from 44 bleeds per subject per year (range 22.7-120.5) to 1 bleed per subject per year (range 0.0-17.4) after switching from on-demand treatment to prophylaxis.4,a
  • 42% of patients reported zero bleeds during 1 year on prophylaxis.4,a
  • The patients who achieved these results were adherent to the prescribed number of prophylactic infusions.b
  • The efficacy of ADVATE was evaluated in 2 prophylaxis treatment regimens, compared to on-demand4,a:
    • Standard prophylaxis
      20-40 IU/kg every 48 hours
    • Pharmacokinetic (PK)-driven prophylaxis
      20-80 IU/kg every 72 hours, targeted to maintain factor VIII trough levels ≥1%

a The clinical study evaluated the relative efficacy of ADVATE in 2 prophylactic regimens —standard prophylaxis (20-40 IU/kg every 48 hours) and pharmacokinetic-driven prophylaxis (20-80 IU/kg every 72 hours, targeted to maintain factor VIII trough levels ≥1%) —compared to that of on-demand treatment in 53 previously treated patients with severe to moderately severe hemophilia A. Initial treatment with 6 months of on-demand therapy was followed by 12 months of either prophylactic regimen.

b Each subject in the per protocol group was adherent to >90% of the prescribed number of prophylactic infusions; no subject in the study surpassed the upper boundary of 110% of the prescribed number of prophylactic infusions.

Selected Important Risk Information

  • 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, unusual taste, 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.

Please scroll below for Detailed Important Risk Information

Dosage and Administration Information for Prophylaxis Use

  • For intravenous use after reconstitution only.
  • Your healthcare provider will tell you how much ADVATE to use based on your weight, the severity of your hemophilia A, and where you are bleeding.

Infusion Information for ADVATE

You should be trained on how to do infusions by your hemophilia treatment center or your healthcare provider. The maximum infusion rate is 10 mL/min.

About Annual Bleed Rate (ABR)

  1. KNOW YOUR ABR

    ABR is the number of bleeds a person experiences over the course of one year. If you don’t have a year’s worth of bleeds tracked, simply take the number of bleeds that you had in the last month and multiply by 12 as an estimate.

  2. SET YOUR ABR GOAL

    Determine the bleed rate that you’d like to achieve.

  3. PARTNER WITH YOUR HEMOPHILIA TREATMENT CENTER (HTC)

    Develop a treatment plan to help reach your ABR goal.

Get 6 free sample doses of ADVATE.Find Out How

ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is a medicine used to replace clotting factor VIII that is missing in people with hemophilia A (also called “classic” hemophilia). ADVATE is used to prevent and control bleeding in people with hemophilia A. Your healthcare provider may give you ADVATE when you have surgery.

ADVATE is not used to treat von Willebrand Disease.

Detailed Important Risk Information for ADVATE

You should not use ADVATE if you are allergic to mice or hamsters or any ingredients in ADVATE.

You should tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines and dietary supplements, have any allergies, including allergies to mice or hamsters, are nursing, are pregnant, or have been told that you have 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.

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, unusual taste, 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.

Call your healthcare provider right away about any side effects that bother you or if your bleeding does not stop after taking ADVATE.

Please see ADVATE full Prescribing Information (PDF).

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.