ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A (congenital Factor VIII deficiency). Your healthcare provider (HCP) may give you ADYNOVATE when you have surgery. ADYNOVATE can reduce the number of bleeding episodes when used regularly (prophylaxis). ADYNOVATE is not used to treat von Willebrand disease.

ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called classic hemophilia). ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A. Your healthcare provider (HCP) may give you ADVATE when you have surgery. ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis). ADVATE is not used to treat von Willebrand disease.

ADYNOVATE®: Support and Resources.

Support throughout your treatment journey

Takeda has a variety of resources to help patients who have been prescribed ADYNOVATE including information, guidance, and resources regarding their treatment. Talk to your healthcare provider about your goals for treatment.

ADYNOVATE is covered^† on Over 91%^‡ of Commercial and Medicaid health plans¹

^†Source: FINGERTIP FORMULARY^®, as of 06/15/2020, is subject to change without notice by health plan or state.

^‡Product coverage divided by total therapeutic category coverage, based on the Rx and Medical coverage using diagnosis-related group (DRG) medical lives.

Freedom of choice^™

Free trial program

The FREEDOM OF CHOICE Trial Program for ADYNOVATE provides, at no cost, eligible and prescribed patients with hemophilia A with 8 doses of ADYNOVATE.

Details you need to know:

This program is available to new
ADYNOVATE patients only
Patients must work with their healthcare
provider and Takeda to participate^§
Must be for an approved use

^§Other restrictions may apply. See Program Terms & Eligibility.

Download form

Hematology Support Center (HSC)

When you’re prescribed ADYNOVATE, HSC’s dedicated product support is here for you. At HSC, we see a person, not a patient. We know that living with a bleeding disorder looks different for everyone. We get to know you, understand who you are, and learn what’s most important to you—so we can focus on what you specifically need when it comes to your prescribed Takeda treatment. After you enroll in HSC, you’ll be connected with an HSC Case Manager. They’ll address your questions and concerns and help determine next steps. And as needed, they’ll connect you to other HSC specialists. Because our goal is to make your journey a little easier. Have questions? Call HSC at 1-888-229-8379 Monday through Friday, 8:30 am to 8:00 pm ET.

If English is not your preferred language, let us know. We can communicate with you over the phone using a translation service.

Visit Hematologysupport.com

If you have been prescribed ADYNOVATE, here are a few ways that the HSC can help:

Case Managers (CMs)

When you call the Hematology Support Center, you’ll be connected with a Case Manager. Your CM is the first person who can help when you have a question. Their job is to address concerns you may have and help determine next steps.

CoPay Assistance

Takeda’s HSC Co-Pay Assistance Program can help you save on your prescribed Takeda treatment.^‖ The program can cover up to 100% of your out-of-pocket co-pay costs, if you’re eligible. To be eligible for this program, you must:

Be prescribed a Takeda treatment for a condition it’s approved by the Food and Drug Administration (FDA) to treat. This is called an“ approved indication.” Ask your healthcare provider if you’re not sure.
Have commercial insurance. This includes Health Insurance Marketplace plans. Commercial insurance does not include Medicare, Medicaid, Veterans Affairs (VA), or other federal or state health plans.
Be enrolled in Takeda’s HSC.

See below for terms and conditions

Patient Access Manager (PAMs)

Your Patient Access Manager (PAM) is an insurance expert. Your PAM can:

Walk you through the insurance process step by step
Help you understand what’s covered, what’s not, and what to do next
Provide information about options that may help cover your prescribed Takeda treatment costs

Educational Tools and Resources

Living with a bleeding disorder looks different for everyone. We understand that what you need isn’t always what everyone else needs. Our specialists can help you understand your condition and ADYNOVATE. They can connect you with community support resources. If needed, they can also provide you with assistance in Spanish.

^‖IMPORTANT NOTICE

Takeda’s HSC Co-Pay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third party payer, whether public or private. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Copayment assistance under the Program is not transferable. The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately at 1-888-229-8379. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]

Important Information

What is ADYNOVATE?

ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A (congenital Factor VIII deficiency).
Your healthcare provider (HCP) may give you ADYNOVATE when you have surgery.
ADYNOVATE can reduce the number of bleeding episodes when used regularly (prophylaxis).

ADYNOVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

Who should not use ADYNOVATE?

Do not use ADYNOVATE if you:

Are allergic to mice or hamster protein
Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]

Tell your HCP if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

What should I tell my HCP before using ADYNOVATE?

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 mice or hamsters.
Are breastfeeding. It is not known if ADYNOVATE passes into your milk and if it can harm your baby.
Are or become pregnant. It is not known if ADYNOVATE may harm your unborn baby.
Have been told that you have inhibitors to factor VIII (because ADYNOVATE may not work for you).

What important information do I need to know about ADYNOVATE?

You can have an allergic reaction to ADYNOVATE. 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, lightheadedness, dizziness, nausea or fainting.
Do not attempt to infuse yourself with ADYNOVATE unless you have been taught by your HCP or hemophilia center.

What else should I know about ADYNOVATE 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 ADYNOVATE 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 ADYNOVATE?

The common side effects of ADYNOVATE are headache, diarrhea, rash, nausea, dizziness, and hives. These are not all the possible side effects with ADYNOVATE. Tell your HCP about any side effects that bother you or do not go away.

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 ADYNOVATE Full Prescribing Information and discuss with your HCP.

ADVATE^® [Antihemophilic Factor (Recombinant)] Important Information

What is ADVATE?

ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called "classic" hemophilia).
ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A. Your healthcare provider (HCP) may give you ADVATE when you have surgery.
ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).

ADVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

Who should not use ADVATE?

Do not use ADVATE if you:

Are allergic to mice or hamsters.
Are allergic to any ingredients in ADVATE.

Tell your HCP if you are pregnant or breastfeeding because ADVATE may not be right for you.

What should I tell my HCP before using ADVATE?

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 mice or hamsters.
Are breastfeeding. It is not known if ADVATE passes into your milk and if it can harm your baby.
Are or become pregnant. It is not known if ADVATE may harm your unborn baby.
Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

What important information do I need to know about ADVATE?

You can have an allergic reaction to ADVATE. Call your HCP right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
Do not attempt to infuse yourself with ADVATE unless you have been taught by your HCP or hemophilia center.

What else should I know about ADVATE 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 ADVATE 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 ADVATE?

Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, unusual taste, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash. Tell your HCP about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.

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 ADVATE Full Prescribing Information and discuss with your HCP.

myPKFiT^® for ADYNOVATE Patients Mobile Application Intended Use

The myPKFiT for Patients Mobile Application (“myPKFiT Mobile App”) is intended for use by patients with hemophilia A being treated with ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] who are 12 years of age or older with a body weight of 29 kg or higher and their caregivers.
The myPKFiT Mobile App is designed to make it convenient for you to record your infusion and bleed events, track your estimated Factor VIII levels following a prophylactic infusion, and export the data for review by your health care provider (“HCP”).
Your HCP can use the myPKFiT software to generate ADYNOVATE dosage amount and frequency recommendations for routine prophylaxis using your age, body weight information, and laboratory tests that measure your Factor VIII clotting activity. Using myPKFiT software, HCPs can evaluate various prophylaxis dose regimens tailored to your individual needs and treatment plan.
myPKFiT Mobile App should only be used by hemophilia A patients treated with ADYNOVATE, as per the ADYNOVATE Prescribing Information.
myPKFiT Mobile App is not indicated for use by patients with von Willebrand disease. myPKFiT Mobile App should not be used by patients who have developed inhibitors to Factor VIII products.

myPKFiT for Patients Mobile Application is Rx only. For safe and proper use of the myPKFiT Mobile App, please refer to the complete instructions for use in the User Manual.

Support throughout your treatment journey

ADYNOVATE is covered† on Over 91%‡ of Commercial and Medicaid health plans1

Helpful resources

ADYNOVATE is covered^† on Over 91%^‡ of Commercial and Medicaid health plans¹