Notice Regarding BAXJECT II Reconstitution Devices Packaged with RECOMBINATE.

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

RECOMBINATE Treatment1:

  • RECOMBINATE is recombinant Factor VIII, a clotting factor that is deficient in people with hemophilia A. RECOMBINATE is used to help control bleeds when they occur and prevent future bleeds. RECOMBINATE does not treat von Willebrand disease. Learn More About Efficacy
  • RECOMBINATE has an established safety profile1,3,4 Learn More About Safety
  • RECOMBINATE can be refrigerated [36° - 46°F (2° - 8°C)] or stored at room temperature, not to exceed 86°F (30°C).1 Learn More About Storage

Efficacy

Effective Bleed Control1,3,4

The safety and efficacy of RECOMBINATE was assessed in two prospective, open-label, multicenter studies in patients with hemophilia A who had previously been treated with plasma-derived Factor VIII and in patients who had not received prior treatment.1,3

The 69 patients with previous treatment of plasma-derived Factor VIII received RECOMBINATE treatment on an on-demand basis to treat bleeding episodes and also for the prevention of bleeds (prophylaxis) over a 48-month study period.1,3

RECOMBINATE treatment was successful in managing spontaneous bleeding episodes, including into joint spaces, soft tissue, and muscle bleeds.1

RECOMBINATE treatment was also effective in stopping bleeding in surgeries (a total of 24 procedures in 13 patients).1,3

An ongoing study assessed the effectiveness of RECOMBINATE in preventing bleeds in previously untreated patients with hemophilia A. The initial study group consisted of 79 patients, with 76 having received at least one infusion of RECOMBINATE. Following enrollment, patients were treated on demand for acute bleeding episodes or for the prevention of future bleeds (prophylaxis). The location, type of hemorrhage, and the time of onset of symptoms were recorded for each new bleeding event. RECOMBINATE treatment appropriately managed hemostasis during spontaneous bleeding episodes, intracranial hemorrhage, and surgical procedures. To date, this cohort has been given 12,209 infusions totaling over 11,277,043 IU of RECOMBINATE.1,4

Safety

Established Safety Profile1,3,4

The safety and efficacy of RECOMBINATE was assessed in two prospective, open-label, multicenter studies in patients with hemophilia A who had previously been treated with plasma-derived Factor VIII and in patients who had not received prior treatment.1,3,4

None of the 69 hemophilia A patients that had been previously treated with plasma-derived Factor VIII developed an inhibitor. These patients were inhibitor- free when they enrolled into the study and did not develop an inhibitor after receiving RECOMBINATE during the 48-month study period.1

Of the 73 previously untreated patients in the study, 73 patients with Factor VIII levels less than or equal to 2% received at least 1 infusion of RECOMBINATE and were tested for an inhibitor after treatment. During the study, 23 patients developed inhibitors to factor VIII. Of these patients, 13 displayed no detectable factor VIII inhibitors at study exit.1

Selected Important Risk Information for RECOMBINATE

What are the possible side effects of RECOMBINATE [Antihemophilic Factor (Recombinant)]?

You could have an allergic reaction to RECOMBINATE.

Call your healthcare provider right away and stop treatment if you get a:

  • rash or hives
  • itching
  • tightness of the throat
  • chest pain or tightness
  • difficulty breathing
  • light-headed, dizziness
  • fainting

The most common side effects are chills, flushing, rash, and nose bleeds. These are not all the possible side effects with RECOMBINATE. You can ask your healthcare provider for information that is written for healthcare professionals. Tell your doctor about any side effect that bothers you or that does not go away.

What else should I know about RECOMBINATE [Antihemophilic Factor (Recombinant)] 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. Call your healthcare provider right away if your bleeding does not stop after taking RECOMBINATE. Consult with your healthcare provider 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.

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

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.1

RECOMBINATE vials

Reconstitute with 5 mL of Sterile Water for Injection using BAXJECT® II

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 kit

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 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 vials containing powdered product (without sterile diluent added) should be stored in a refrigerator (2° to 8°C [36° to 46°F]) or at room temperature (up to 30°C [86°F]).

If you choose to store RECOMBINATE at room temperature:

  • It should remain at room temperature until infused
  • Do not put room temperature product back in the refrigerator

Store vials in their original box and protect them from extreme exposure to light. Do not freeze.

Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. Any RECOMBINATE left in the vial at the end of your infusion should be discarded.

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 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?

For eligible commercially insured Takeda patients, the Hematology Support Center’s CoPay Assistance Program covers out-of-pocket expenses*† related to a patient’s Takeda Hematology treatment*† for which there is a co-pay, such as deductibles and coinsurances, up to the program maximum.

Visit hematologysupport.com for more information, as well as full Terms and Conditions for Takeda’s CoPay Assistance Program.

*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. Takeda reserves the right to rescind, revoke, or amend this offer at any time without notice. Full terms and conditions apply to each program.

†Nonmedication expenses, such as ancillary supplies or administration-related costs, are not eligible.

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

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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.