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ADVATE® WITH BAXJECT III® Reconstitution System

  • Easy one-step activation for reconstituting ADVATE [Antihemophilic Factor (Recombinant)] in a BAXJECT III system1
  • Eliminates the need to disinfect, as vials are already assembled in the system housing1
  • Store ADVATE in a refrigerator (2° to 8°C [36° to 46°F])1 or
  • ADVATE may be stored at room temperature (up to 30°C [86°F]) for up to 6 months, not to exceed the expiration date; product should not be returned to refrigerator.1

Watch Reconstitution Demonstration Video with BAXJECT III Reconstitution System

For detailed step-by-step instructions for reconstituting ADVATE with BAXJECT III Reconstitution System, watch the video below or download the Instructions for Use and Troubleshooting Guide.

Full Prescribing Information Important Risk Information
Full Prescribing Information Important Risk Information

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.

Watch Reconstitution Troubleshooting Video with BAXJECT III Reconstitution System

Full Prescribing Information Important Risk Information
Full Prescribing Information Important Risk Information
Indications and Detailed Important Risk Information for ADVATE [Antihemophilic Factor (Recombinant)].
See full Prescribing Information.

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

Indications

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.

DETAILED IMPORTANT RISK INFORMATION

You should not use ADVATE if you:

  • Are allergic to mice or hamsters.
  • Are allergic to any ingredients in ADVATE.

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:

  • Have or have had any medical problems.
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
  • Have any allergies, including allergies to mice or hamsters.
  • Have been told that you have inhibitors to factor VIII (because ADVATE may not work for 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.