Intended for US audience only.
Intended for US audience only.
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 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.
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.
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 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 is available in a range of options for a single-vial dose. Available dosage strengths are 250 IU, 500 IU, 1000 IU, 1500 IU, and 2000 IU. Now RECOMBINATE is packaged with a lower 5 mL diluent volume and includes the BAXJECT II Needle-less Transfer Device1.
For more information talk to your healthcare provider.
The 10 mL diluent vial has been reduced to a 5 mL diluent vial. However, the size of the unit carton and product vial have remained unchanged. In addition, the color of the unit carton is a gray background for the 10 mL diluent configuration, and a blue background for the 5 mL diluent configuration for easier differentiation.1
We understand that health insurance is top of mind for you. Baxter Healthcare Corporation offers access to the CARE Program which helps people living with hemophilia navigate the often complex and challenging health insurance world. Whether you are looking to understand changes in your policy or want to know what healthcare reform means to you, the CARE Program is here to help, regardless of the treatment you use.
Whether you’re a caregiver or a person living with hemophilia, Baxter offers kits, manuals, videos, and other materials to help explain how to manage your hemophilia A whatever your stage in life or needs. To view these educational materials and other useful resources from Baxter and the hemophilia community, which are available regardless of the treatment utilized, go to ThereForYou.com.
Please contact Baxter’s Medical Information and a licensed clinician will respond to your inquiry.
Medical Information
1-866-4BIOSCI (424-6724)
8:00 am - 5:00 pm (PST)
medinfo@baxter.com
You can use our Baxter Representative Finder to connect with your local
Baxter Representative.
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 DeviceThe first needle-less transfer device for preparing Factor VIII concentrate3 |
| 2006 |
BAXJECT II DeviceThe evolution of BAXJECT with enhancements that make for fast and easy mixing3 |
| 2010 |
RECOMBINATE 1500 IU and 2000 IUTwo opportunities for a single-vial dosing option |
| 2011 |
RECOMBINATE 5 mLLower diluent offers less volume for every infusion |
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.
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.
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.