Experience Matters

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

As the first genetically engineered factor VIII concentrate, RECOMBINATE changed the approach to hemophilia A treatment when it was first available in the United States in 1992.2 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.

Selected Important Risk Information for RECOMBINATE [Antihemophilic Factor (Recombinant)]

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.

The most common side effects are chills, flushing, rash, and nose bleed.

Please see RECOMBINATE Detailed Important Risk Information below.

Please see RECOMBINATE full Prescribing Information in the menu.

RECOMBINATE Treatment Offers:

Efficacy

Effective Bleed Control

Demonstrated Efficacy in a Clinical Study1,3,4

The efficacy and safety of RECOMBINATE for on-demand treatment were evaluated in 2 open-label, multicenter clinical studies. The first, a previously treated patients (PTP) study, was comprised of 69 patients—67 had severe hemophilia A and 2 had moderate hemophilia A (baseline FVIII levels ≤5% normal)—who received factor VIII during a 48-month trial. The second, a previously untreated patients (PUP) study, was comprised of 79 patients with severe hemophilia A, of whom 76 had received at least 1 infusion of RECOMBINATE.

In both of the clinical trials, efficacy was demonstrated for the management of bleeding in pediatric and adult patients with hemophilia A.

Selected Important Risk Information for RECOMBINATE [Antihemophilic Factor (Recombinant)]

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.

Please see RECOMBINATE Detailed Important Risk Information below.

Please see RECOMBINATE full Prescribing Information in the menu.

Safety

Demonstrated Safety Profile

During the previously treated patients (PTP) study, no patient developed de novo evidence of a factor VIII inhibitor for the duration of the study (mean number of exposure days: 241±180). One participant with a history of inhibitors exhibited low-titer inhibitor activity at 6 months, which resolved by 9 months.1,3

During the previously untreated patients (PUP) study, 22 of the 73 evaluable subjects developed inhibitors to factor VIII. Of these, 13 participants displayed no detectable factor VIII inhibitors at study exit.1

Selected Important Risk Information for RECOMBINATE [Antihemophilic Factor (Recombinant)]

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.

The most common side effects are chills, flushing, rash, and nose bleed.

Your body may form inhibitors to Factor VIII. Inhibitors are part of your body’s normal defense mechanism. 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.

Please see RECOMBINATE Detailed Important Risk Information below.

Please see RECOMBINATE full Prescribing Information in the menu.

Dosing

Your Life Is Bigger Than Hemophilia A, and Your Factor VIII Helps Keep it That Way

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

RECOMBINATE bottles

Low-Volume 5 mL Diluent

All 5 RECOMBINATE dosage strengths are packaged with the same low-volume 5 mL Sterile Water for Injection, USP (diluent) and include the BAXJECT II Needleless Transfer Device.1

You should be trained on how to do infusions by your hemophilia treatment center or doctor. The maximum infusion rate is 5 mL per minute.

RECOMBINATE bottles

BAXJECT II Product Information

Rx Only. For safe and proper use of this device, please refer to the instructions for use. The BAXJECT II device is intended for use with a single vial of product and is for single use only. Therefore, reconstitution and withdrawing a second vial into the syringe requires a second BAXJECT II device.

Convenient Storage1

RECOMBINATE should be stored at refrigerated temperature: 36°F to 46°F, but may be stored at room temperature, not to exceed 86°F.

Providing Continuous Supply5

The RECOMBINATE production process has had a long history of continuous supply. To date, no shortages of RECOMBINATE have been experienced in the US. Over 8 billion units of RECOMBINATE have been distributed worldwide.

Selected Important Risk Information for RECOMBINATE [Antihemophilic Factor (Recombinant)]

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).

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 Detailed Important Risk Information below.

Please see RECOMBINATE full Prescribing Information in the menu.

RECOMBINATE FAQs

Frequently Asked Questions

How is RECOMBINATE supplied?

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. RECOMBINATE is packaged with a low-volume 5 mL Sterile Water for Injection, USP (diluent) and includes the BAXJECT II Needleless Transfer Device.1 You should be trained on how to do infusions by your hemophilia treatment center or doctor. The maximum infusion rate is 5 mL per minute.

BAXJECT II Product Information

Rx Only. For safe and proper use of this device, please refer to the instructions for use. The BAXJECT II device is intended for use with a single vial of product and is for single use only. Therefore, reconstitution and withdrawing a second vial into the syringe requires a second BAXJECT II device.

Where can I find information on insurance or factor assistance?

Baxter is committed to evolving our hemophilia support program to meet your changing needs with resources and assistance especially for you. That is why we offer the Baxter CoPay Assistance Program featuring:

  • Financial assistance and insurance support
  • Information, tools, and answers on living with hemophilia A

How can I contact a Baxter representative in my area?

Use our Baxter Representative Finder to connect with your local Baxter representative.

History of RECOMBINATE

RECOMBINATE - Here to Stay

Long recognized globally as a trusted and experienced innovator in the evolution of hemophilia care, Baxter plays a leading role in the development of recombinant factor replacement treatments.

RECOMBINATE History

1992 RECOMBINATE [Antihemophilic Factor (Recombinant)] The first genetically engineered factor VIII concentrate2
2002 BAXJECT Device The first needleless transfer device for preparing factor VIII concentrate5
2008 BAXJECT II Device The evolution of BAXJECT with enhancements that make for fast and easy mixing5
2009 RECOMBINATE 5 mL Lower diluent offers less volume for every infusion1,5
2010 RECOMBINATE 1500 IU and 2000 IU Two opportunities for a single-vial dosing option1,5

Support Programs

Baxter offers support and resources that may help you reach your goals.

NAVA logo

Baxter’s NAVA program is a highly personalized experience designed to help you navigate life and take it where you want it to go. It’s a program filled with individualized information, valuable tools, and helpful resources customized to provide education and support that are relevant to you

NAVA homepage

CARE logo

Baxter’s CARE program offers members in the bleeding disorders community education, advocacy, and resources related to health insurance. For more information, call 1-888-BAXTER9 (229-8379) Monday through Friday between 8:30 a.m. and 5:30 p.m. ET.

Baxter support programs are available to all patients, regardless of treatment

Baxter: Committed to people with hemophilia for over 60 years

Important Risk Information for RECOMBINATE [Antihemophilic Factor (Recombinant)]
Please read below for Indications and Detailed Important Risk Information for RECOMBINATE. See full Prescribing Information.

Indications 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.

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.