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LIFE
HAPPENS

AND ADVATE^® WILL
BE THERE WHEN IT
DOES

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. ADVATE is not used to treat von Willebrand disease.¹

*In clinical trials, ADVATE has demonstrated the ability to help patients prevent bleeding episodes using a prophylaxis regimen.

For people with hemophilia A, ADVATE has a legacy of treatment experience and provides clinically proven bleed protection.^*1,2

Learn more

Selected 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.

Please see Detailed Important Risk Information below.

ADVATE has been proven effective for prophylaxis, on-demand, and surgical use in children and adults and has an established safety profile.^1,3

Selected Important Risk Information

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).

Please see Detailed Important Risk Information below.

Discover personalization with the
myPKFiT^® mobile app

The myPKFiT^® mobile app for ADVATE can help you and your healthcare provider personalize your treatment.^4,5

Flexible dosing
options

ADVATE has multiple potencies that may fit your factor VIII replacement therapy needs.¹

ADVATE support

Takeda has a variety of resources and programs to help you every step of the way with your treatment on ADVATE.

Get started

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 full Prescribing Information and discuss with your HCP.

myPKFiT for ADVATE 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 ADVATE [Antihemophilic Factor (Recombinant)] who are 16 years of age or older with a body weight of 45 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 ADVATE 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 ADVATE, as per the ADVATE 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.

References

ADVATE Prescribing Information.
Data on file. Takeda Pharmaceutical Company Limited. 2018.
Shapiro AD, Schoenig-Diesing C, Silvati-Fidell L, Wong WY, Romanov V. Integrated analysis of safety data from 12 clinical interventional studies of plasma- and albumin-free recombinant factor VIII (rAHF-PFM) in haemophilia A. Haemophilia. 2015;21(6):791-798.
myPKFiT for Healthcare Professionals v3.3 User Manual. 2019.
Valentino LA. Considerations in individualizing prophylaxis in patients with haemophilia A. Haemophilia. 2014;20(5):607-615.

Selected Important Risk Information

Do not use ADVATE if you are allergic to mice or hamsters or are allergic to any ingredients in ADVATE. Tell your HCP if you are pregnant or breastfeeding because ADVATE may not be right for you.