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Takeda

300 Shire Way
Lexington, MA 02421
(617) 349-0200

For questions on Takeda's product support program, please call Takeda's Hematology Support Center 1-888-229-8379.

For general questions about RECOMBINATE™ [Antihemophilic Factor (Recombinant)] BAXJECT® II Hi-Flow Needleless Transfer Device or other clinical questions regarding RECOMBINATE, please contact your healthcare provider.

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.

What is RECOMBINATE?

  • RECOMBINATE is a prescription medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia).
  • RECOMBINATE is used to prevent and control bleeding in people...

Detailed Important Risk Information

Who should not use RECOMBINATE?

Do not use RECOMBINATE if you:

  • Are allergic to mouse, hamster, or bovine proteins...

RECOMBINATE [Antihemophilic Factor (Recombinant)] Important Information

What is RECOMBINATE?

  • RECOMBINATE is a prescription medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia).
  • RECOMBINATE is used to prevent and control bleeding in people with hemophilia A. Your healthcare provider (HCP) may give you RECOMBINATE when you have surgery.

RECOMBINATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

Who should not use RECOMBINATE?

Do not use RECOMBINATE if you:

  • Are allergic to mouse, hamster, or bovine proteins.
  • Are allergic to any ingredients in RECOMBINATE.

Tell your HCP if you are pregnant or breastfeeding because RECOMBINATE may not be right for you.

What should I tell my HCP before using RECOMBINATE?

Tell your HCP 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 mouse, hamster, or bovine proteins.
  • Are breastfeeding. It is not known if RECOMBINATE passes into your milk and if it can harm your baby.
  • Are or become pregnant. It is not known if RECOMBINATE may harm your unborn baby.
  • Have been told that you have inhibitors to factor VIII (because RECOMBINATE may not work for you).

What important information do I need to know about RECOMBINATE?

  • You could have an allergic reaction to RECOMBINATE. Symptoms of an allergic reaction may include rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, or fainting. If you experience any of these symptoms, stop using RECOMBINATE and call your HCP right away.

What else should I know about RECOMBINATE and Hemophilia A?

  • 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 RECOMBINATE from working properly. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

What are possible side effects of RECOMBINATE?

  • The most common side effects reported during clinical studies with RECOMBINATE include: chills, flushing, rash, and nose bleeds. Tell your HCP about any side effects that bother you or do not go away or if your bleeding does not stop after taking RECOMBINATE.

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.

For additional safety information, click here for Prescribing Information and discuss with your HCP.