Are you taking HEMOFIL M® or RECOMBINATE®?
Important Information for Patients
We’d like to inform you that Takeda has made the difficult decision to globally discontinue these medicines but will continue to provide them until the supply is used up or expired in mid-2026. It is important to note there is no quality issue with either HEMOFIL M or RECOMBINATE [Antihemophilic Factor (Recombinant)].
We recognize how long you have relied on HEMOFIL M and RECOMBINATE for your hemophilia A therapy, so please know that this was not a decision we made lightly. We are here to support you through this transition.
We encourage you to consult with your healthcare team now to allow time to develop longer-term plans.
IMPORTANT INFORMATION
What is ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], ADVATE [Antihemophilic Factor (Recombinant)], RECOMBINATE [Antihemophilic Factor (Recombinant)] and HEMOFIL M [Antihemophilic Factor (Human), Method M, Monoclonal Purified]?
- ADYNOVATE and ADVATE are prescription, injectable medicines that are used to replace clotting factor, to help treat and control bleeding in children and adults with hemophilia A (congenital factor VIII deficiency, also called “classic” hemophilia).
- RECOMBINATE and HEMOFIL M are used to prevent and control bleeding in people with hemophilia A.
- Your healthcare provider (HCP) may give you ADYNOVATE, ADVATE or RECOMBINATE when you have surgery.
- ADYNOVATE and ADVATE can each reduce the number of bleeding episodes when used regularly (prophylaxis).
ADYNOVATE, ADVATE, RECOMBINATE and HEMOFIL M are not used to treat von Willebrand disease.
A transition of therapy may be difficult. Takeda has options for you
For more than 70 years, we’ve pioneered innovations including RECOMBINATE, the first recombinant FVIII product in the US, and continue to work hard to improve the standard of care for hemophilia patients like you. Our commitment to your health hasn't changed.
Explore Takeda Hemophilia A Products and Consider ADVATE® or ADYNOVATE®
When you are ready, please consider 2 products in our Takeda factor VIII family that are similar to HEMOFIL M and RECOMBINATE. ADVATE and ADYNOVATE are widely used today and may meet your individual needs.
| For Adults and Children With Hemophilia A . | |||||||
|---|---|---|---|---|---|---|---|
| HEMOFIL M , to be discontinued. | RECOMBINATE , to be discontinued. |  |  | ||||
 | What is it? Hemofil M, HEMOFIL M is a clotting factor replacement made from human plasma . | What is it? Recombinate, First recombinant FVIII product in the US . | What is it? ADVATE, Most widely used FVIII product in the US* with proven efficacy and safety profiles . | What is it? ADYNOVATE, Built on ADVATE but has an extended half-life so it lasts longer in the body than ADVATE . | |||
| | When was it approved? Hemofil M, 1966 . | When was it approved? Recombinate, 1992 . | When was it approved? ADVATE, 2003 . | When was it approved? ADYNOVATE, 2015 . | |||
| | What type of FVIII is it? Hemofil M, Plasma-derived . | What type of FVIII is it? Recombinate, Recombinant . | What type of FVIII is it? ADVATE, 3rd generation recombinant standard half-life . | What type of FVIII is it? ADYNOVATE, 3rd generation recombinant extended half-life . | |||
| | How can it be used? Hemofil M, On demand and surgery . | How can it be used? Recombinate, On demand and surgery . | How can it be used? ADVATE and ADYNOVATE, On demand, surgery, and/or prophylaxis . | ||||
| | How is it dosed? Hemofil M, Please see PI . | How is it dosed? Recombinate, Please see PI . | How is it dosed? ADVATE, Prophylaxis every other day (3 to 4 times weekly), alternatively every 3rd day; on demand and surgery, please see PI . | How is it dosed? ADYNOVATE, Prophylaxis twice weekly dosing, same 2 days
each week; on demand and surgery, please see PI . | |||
| | How is it mixed? Hemofil M,
Double-ended needle . | How is it mixed? Recombinate,
BAXJECT® II 15 reconstitution steps . | How is it mixed? ADVATE and ADYNOVATE,
BAXJECT III® 3 reconstitution steps . | ||||
| | Is there coverage? Hemofil M and Recombinate, 99%† commercial coverage . | Is there coverage? ADVATE and ADYNOVATE, Covered on 99%† of commercial and Medicaid health plans . | |||||
*Based on units sold as of July 2022
Source: FINGERTIP FORMULARY® as of 3/08/23; is subject to change without notice by a health plan or state.
†Product coverage divided by total therapeutic coverage, based on the Rx and Medicaid coverage using DRG medical lives.
Learn more about your Takeda FVIII options, ADVATE and ADYNOVATE
- ADVATE is the most widely used FVIII in the US* with over 43 billion IUs‡ distributed globally
- It's also the #1 FVIII product used for breakthrough bleeds in patients on nonfactor therapy§
- ADYNOVATE was built on the ADVATE molecule but with twice-weekly dosing
- Both come prepackaged with the BAXJECT III® reconstitution system for an easy, single-vial, 1-step activation process
- Clinical results are also available for review from patients who transitioned from HEMOFIL M or RECOMBINATE to ADVATE or ADYNOVATE
- Patient education and free trial program for eligible patients are available
*As of July 2022.
‡IU, international unit.
§Based on units sold from DSA-SP 12-month units data (October 2019 to September 2024). DSP-SP covers ~40% of the market.
Do you have questions? We have answers
- Reach out to a Community Education Specialist
For more resources on ADVATE, ADYNOVATE and BAXJECT III
(including administration videos)
Frequently asked questions
Please review the answers to the most frequently asked questions on topics including supply timelines and alternative options.
The FREEDOM OF CHOICE Trial Program for ADVATE and ADYNOVATE provides eligible patients with hemophilia A with trial doses at no cost.
6
Free-trialdoses
8
Free-trialdoses
This program is available to new ADVATE and ADYNOVATE patients only‡
- Patients must work with their healthcare provider and Takeda to participate
- Must be for an approved use
- Visit the registration forms for ADVATE and ADYNOVATE to learn more
‡Other restrictions may apply. See Program Terms & Eligibility.
Welcome to Takeda Patient Support
When you’re prescribed a Takeda treatment, Takeda Patient Support is here for you. Our support specialists are here to help you get the answers and information you need. Some of the ways we can assist include:
- Enrolling you in the Takeda Patient Support Co-Pay Assistance Program, if you’re eligible*
- Offering insurance support by reviewing your coverage and helping you understand what financial options may be available
- Working with your specialty pharmacy (or site of care) to help you receive your prescribed Takeda treatment (if available for your therapy)
*To be eligible, you must be enrolled in Takeda Patient Support and have commercial insurance. Other terms and conditions apply. Call us for more details.
WANT TO CONNECT?
Dedicated teams are available to assist you Monday through Friday with extended evening business hours. Visit TakedaPatientSupport.com 1-888-229-8379 for more information.
Not enrolled? Visit TakedaPatientSupport.com for information on how to enroll. If English is not your preferred language, let us know. We may be able to assist you in the language of your choosing.