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References

  1. RECOMBINATE prescribing information. Westlake Village, CA: Baxter Healthcare Corporation; December 2010.
  2. Kingdon HS, Lundblad RL. An adventure in biotechnology: the development of haemophilia A therapeutics – from whole-blood transfusion to recombinant DNA to gene therapy. Biotechnol Appl Biochem. 2002;35(Pt 2):141-148.
  3. Data on file. Westlake Village, CA: Baxter Healthcare Corporation.

Experience Matters

There are some things in life that work for you, like controlling bleeds with RECOMBINATE [Antihemophilic Factor (Recombinant)].1

Since its introduction as the first recombinant Factor VIII, patients and healthcare professionals have trusted RECOMBINATE to help manage hemophilia A.2 Baxter continues to listen to the hemophilia community, with an ongoing commitment to meeting the needs of people living with hemophilia A and their families. At Baxter, we know that you are moving forward. We want to move forward with you.

RECOMBINATE 1500 IU bottles

Indication for RECOMBINATE [Antihemophilic Factor (Recombinant)]

RECOMBINATE is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes and for the perioperative management of patients with hemophilia A.

RECOMBINATE is not indicated for von Willebrand’s disease.

Selected Important Risk Information for RECOMBINATE

You should not use RECOMBINATE if you are allergic to mouse, hamster, or bovine proteins or if you are allergic to any ingredients in RECOMBINATE.

RECOMBINATE is for treating patients with Factor VIII deficiency (hemophilia A), and it is essential that you are diagnosed before using RECOMBINATE.

Please scroll down for RECOMBINATE Indication and Detailed Important Risk Information.

Your life is bigger than
hemophilia A. Your
Factor VIII helps keep
it that way.

Dosing Options

RECOMBINATE bottles

Five Opportunities for a Single-Vial Dose

Available in five dosage strengths ranging from 250 IU to 2000 IU,1 RECOMBINATE offers 5 options for the convenience that comes with single-vial dosing with Factor VIII.

All with a low 5 mL Diluent

All five RECOMBINATE dosage strengths are packaged with the same low 5 mL diluent volume and include the BAXJECT II Needle-less Transfer Device. For more information talk to your healthcare provider.

RECOMBINATE FAQs

Frequently Asked Questions

History of RECOMBINATE

Continuing Commitment

The introduction of the 5 mL diluent along with the two dosage strengths of 1500 IU and 2000 IU for RECOMBINATE marked updates in hemophilia A care from Baxter Healthcare Corporation. Keep up with all that Baxter is doing. Register to receive updates in your inbox.

History

1992

RECOMBINATE (Antihemophilic Factor (Recombinant)]

The first recombinant (genetically manufactured) Factor VIII concentrate2

2002

BAXJECT Device

The first needle-less transfer device for preparing Factor VIII concentrate3

2006

BAXJECT II Device

The evolution of BAXJECT with enhancements that make for fast and easy mixing3

2010

RECOMBINATE 1500 IU and 2000 IU

Two opportunities for a single-vial dosing option

2011

RECOMBINATE 5 mL

Lower diluent offers less volume for every infusion

Support Programs

Beyond Factor VIII for Hemophilia A

Baxter Healthcare Corporation is committed to the hemophilia community. In listening to your request for education programs, we’ve developed a range of resources for patients, families, physicians, and nurses, which are available regardless of the treatment used. Baxter is also committed to supporting local and national organizations, community events, and volunteering. To find out more, visit www.ThereForYou.com.

Find your local Baxter Representative.
www.thereforyou.com


Indication for RECOMBINATE [Antihemophilic Factor (Recombinant)]

RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes and for the perioperative management of patients with hemophilia A.

RECOMBINATE is not indicated for von Willebrand’s disease.

Detailed Important Risk Information for RECOMBINATE

You should not use RECOMBINATE if you are allergic to mouse, hamster, or bovine proteins or if you are allergic to any ingredients in RECOMBINATE.

RECOMBINATE is for treating patients with Factor VIII deficiency (hemophilia A), and it is essential that you are diagnosed before using RECOMBINATE.

You should tell your doctor if you have or have had any medical problems; take any medicines, including prescription and non-prescription medicines, dietary supplements and herbal remedies; have any allergies, including allergies to mouse, hamster, or bovine proteins; are nursing; are pregnant; or have been told that you have inhibitors to Factor VIII (because Factor VIII may not work for you).

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 have an allergic reaction, call your doctor right away and stop treatment.

Your body may form inhibitors to Factor VIII. Inhibitors are part of your body’s normal defense system. If you form inhibitors, it may stop RECOMBINATE from working properly. Consult with your doctor to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

The most common side effects are chills, flushing, rash, and nose bleed. Post marketing adverse reactions have been reported and include the following: inhibitors, rapid heartbeat, bluish coloration of the skin, vomiting, stomach pain, body discomfort, injection site reactions, chest pain, chest discomfort, anaphylactic reaction, hypersensitivity, loss of consciousness, headache, tingling sensation, difficulty breathing, cough, airway swelling, localized swelling, hives, and redness of the skin.

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

Please see RECOMBINATE Full Prescribing Information. 5 mL 10 mL

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.