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Detailed Important Risk Information Full Prescribing Information Healthcare
Professional Site Get Updates
Detailed Important Risk Information Full Prescribing Information Healthcare
Professional Site Get Updates


HEMOPHILIA IS A PIECE OF YOU.


NOT ALL OF YOU.

Hear from real people with hemophilia A and discover why they chose ADYNOVATE®.

See patient stories

What is ADYNOVATE? ADYNOVATE is an injectable medicine that is used to help
treat and control bleeding in children and adults with hemophilia A. ADYNOVATE
is not used to treat von Willebrand disease.

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


TREATMENT DESIGNED WITH YOU IN MIND

ADYNOVATE is a twice-weekly treatment that can be personalized to fit your
lifestyle, so you have more time to spend doing the other things that make you,
you.1

Learn more about treatment with ADYNOVATE.

more info

SELECTED 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.


See Detailed Important Risk Information below.



SELECTED 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.


See Detailed Important Risk Information below.


ADYNOVATE IS BUILT ON THE ADVATE® MOLECULE, A PROVEN TREATMENT IN HEMOPHILIA A
PATIENTS.

ADYNOVATE was designed to have a longer half-life than ADVATE. This means
ADYNOVATE will remain in your body longer to help prevent bleeds. Talk to your
healthcare provider to find out what treatment is right for you.1,2

Learn more about taking ADYNOVATE

SELECTED IMPORTANT RISK INFORMATION

What should I tell my HCP before using ADYNOVATE and 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 hamster proteins.
 * Are breastfeeding. It is not known if ADYNOVATE or ADVATE pass into your milk
   or if they can harm your baby.
 * Are or become pregnant. It is not known if ADYNOVATE or ADVATE may harm your
   unborn baby.
 * Have been told that you have inhibitors to factor VIII (because ADYNOVATE or
   ADVATE may not work for you).

See Detailed Important Risk Information below.


HELPING WITH BLEED CONTROL WHEN YOU MAY NEED IT

Discover how ADYNOVATE can be used as on-demand treatment.

See the data


A TREATMENT WITH AN ESTABLISHED AND CONSISTENT SAFETY PROFILE

Learn about the safety profile of ADYNOVATE.

learn more

ADYNOVATE is not indicated for the treatment of von Willebrand Disease.

Tailored treatment

The myPKFiT® mobile app is designed to help
you track infusions, bleeds, and estimated FVIII levels.

See how
ADYNOVATE CoPay Program

Learn more about Takeda's
CoPay Program.

Get more info

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.

--------------------------------------------------------------------------------

References References
 1. ADYNOVATE Prescribing Information
 2. ADVATE Prescribing Information

--------------------------------------------------------------------------------

IMPORTANT RISK INFORMATION

SEE MORE

Do not use ADYNOVATE if you are allergic to mice or hamster protein or 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.

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©2022 Takeda Pharmaceuticals U.S.A., Inc. 300 Shire Way, Lexington, MA 02421.
1-877-TAKEDA-7 (1-877-825-3327). All rights reserved. TAKEDA and the TAKEDA logo
are trademarks or registered trademarks of Takeda Pharmaceutical Company
Limited. ADVATE, ADYNOVATE, BAXJECT, BAXJECT III, FREEDOM OF CHOICE, and myPKFiT
and logo are trademarks or registered trademarks of Baxalta Incorporated, a
Takeda company. All other trademarks are the property of their respective
owners. US-XMP-0217v5.0 08/22

Unless otherwise indicated, images are not actual patients, caregivers or
healthcare providers.



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