Experience Matters

There are some things in life that work for you, like controlling and preventing 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

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:

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.

Efficacy

Effective Bleed Control

Demonstrated Efficacy in Clinical Studies1,3-5

The efficacy and safety of RECOMBINATE for on-demand treatment were evaluated in 2 open-label, multicenter clinical studies.

The first study included 69 previously treated patients (PTPs)-67 with severe hemophilia A and 2 with moderate hemophilia A (baseline factor VIII levels ≤5% normal)-who received factor VIII during a 48-month trial. The primary objective was to confirm comparability of the pharmacokinetics of RECOMBINATE to commercially available factor VIII concentrates and to determine the safety and efficacy of RECOMBINATE.

The second study included 79 previously untreated patients (PUPs) with severe hemophilia A, of whom 76 had received at least 1 infusion of RECOMBINATE. The primary objective of this trial was to assess the risk of developing factor VIII inhibitors after treatment with RECOMBINATE as compared historically to patients treated with plasma-derived factor VIII. Patients were treated on the study for a mean of 223 (±53) weeks.

In both of the clinical trials, efficacy was demonstrated for the management of bleeding in pediatric and adult patients with hemophilia A.1,3,4

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

Established Safety Profile

The previously treated patients (PTPs) study included 69 patients-67 with severe hemophilia A and 2 with moderate hemophilia A (baseline factor VIII levels ≤5% normal)-who received factor VIII during a 48-month trial. During the study no patient developed new 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

The previously untreated patients (PUPs) study included 79 patients with severe hemophilia A, of whom 76 had received at least 1 infusion of RECOMBINATE. Patients were treated on the study for a mean of 223 (±53) weeks. During the 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.1,5

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 that come 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.1

RECOMBINATE bottles

BAXJECT II Hi-Flow Needleless Transfer Device Information1

Rx Only. For safe and proper use of this device, please refer to the instructions for use in the full Prescribing Information. The BAXJECT II device should be used only with the intended product. 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.

Storage information1

RECOMBINATE can be refrigerated [36° - 46°F (2° - 8°C)] or stored at room temperature, not to exceed 86°F (30°C). Avoid freezing to prevent damage to the diluent vial. Do not use beyond the expiration date printed on the box.

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 [Antihemophilic Factor (Recombinant)] 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. 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.1

BAXJECT II Hi-Flow Needleless Transfer Device Information1

Rx Only. For safe and proper use of this device, please refer to the instructions for use in the full Prescribing Information. The BAXJECT II device should be used only with the intended product. 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 copay assistance for RECOMBINATE?

Shire's CoPay Assistance Program* offers financial assistance to eligible patients. If you quality, you may save up to $12,000 in out-of-pocket medication costs over 12 months on RECOMBINATE or receive reimbursement for your portion of your medication costs. Learn more by clicking here.

*Certain restrictions apply. Not valid for prescriptions reimbursed, in whole or in part, by Medicaid, Medicare, Medigap, VA, DoD, TRICARE, or any other federal or state healthcare programs, including state pharmaceutical assistance programs, and where prohibited by the health insurance provider or by law. Offer good only in the United States. Offer void where prohibited by law, taxed, or restricted. Shire reserves the right to rescind, revoke or amend this offer at any time without notice. Full terms and conditions apply to each program.

Non-medication expenses, such as ancillary supplies or administration-related costs, are not eligible.

How can I contact a Shire representative in my area?

Use our Shire Representative Finder to connect with a local Shire representative.

Support Programs

Support programs for you

Please check out our support programs that may be available for you.

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Hematology Support Center provides full service support to you for your coverage and support needs. Now it's easier to explore finding assistance in starting or paying for your hemophilia A treatment, exploring insurance options and more.

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

RECOMBINATE [Antihemophilic Factor (Recombinant)] Important Information

Indications for RECOMBINATE

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.

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 RECOMBINATE full Prescribing Information.