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

Your patients may be eligible to receive 8 free-trial doses of ADYNOVATE with the FREEDOM OF CHOICE program. The free trial program is for new patients only. Participants must receive consultation and approval from their healthcare provider.

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Hematology Support Center

Takeda's Hematology Support Center (HSC) is dedicated to helping patients who have been prescribed Takeda hematology products and healthcare providers who have a patient on or ready to start on a Takeda hematology product. HSC offers help with treatment access, as well as educational resources and information for financial assistance programs. Call 1-888-229-8379 Monday–Friday 8:30AM–8:00PM (ET).

Visit Hematologysupport.com

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

Case Managers

A point of contact who is ready to assist your patients with accessing their treatment

CoPay Assistance

For eligible commercially insured Takeda patients, our 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^†‡§

Patient Access Manager

A Patient Access Manager is available and can provide one-on-one, personalized insurance education and access information

Resources and Education

Connecting patients and their caregivers with educational resources–including a Healthcare Educator who can work with them one-on-one if needed

^†Must meet specific program eligibility requirements and terms and conditions. Certain restrictions apply. Not all Takeda hematology products are available for each program.

^‡These programs are 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 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 each offer at any time without notice.

^§Non-medication expenses, such as ancillary supplies or certain/some administration-related costs, are not eligible.

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 and nausea. 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.

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 and nausea. 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.

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.

Acknowledge + Continue

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