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® Prophylaxis treatment.

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.

Proven bleed protection for children and adults

How does prophylaxis treatment work?

Prophylaxis is a treatment you take regularly to prevent bleeds, rather than waiting for a bleed to happen and then treating it.

Study design

In adolescents and adults 12 years and older
A clinical trial of 137 previously treated patients (age 12 years and older) with severe hemophilia A evaluated how well ADYNOVATE worked over 6 months, in both twice-weekly prophylaxis and on-demand use. 120 patients received a prophylaxis dose of 40-50 IU/kg twice a week, and 17 patients received an on-demand dose of 10-60 IU/kg. The main objective of the study was to compare the annualized bleed rates in the patients receiving prophylaxis and those receiving on-demand treatment.¹

Study results

When changing from on-demand use to prophylaxis:

95%

reduction in median ABR

41.5 median ABR with on-demand treatment versus
1.9 median ABR with prophylactic treatment.¹

ABR=annualized bleed rate
Median is defined as the middle number in a list of numbers arranged in numerical order.

SELECTED IMPORTANT RISK INFORMATION

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).

See Detailed Important Risk Information below.

What is median ABR?

ABR is an acronym for Annualized Bleed Rate. This is a measurement of how many total bleeds a person had over one year's time. Median ABR refers to the middle value in a list of annual bleed rates.

“I strive for zero bleeds, so my doctor called me to talk about ADYNOVATE.”^† —Brett, actual patient”

Find out how people like you are living with hemophilia A and treating with ADYNOVATE.
See their stories

^†This is Brett's experience, not everyone will have the same experience on ADYNOVATE.

Get better organized by tracking your
bleeds and infusions all in one place.

Download bleed and infusion tracker worksheet

Go for it! Set and track your treatment,
lifestyle, and overall health goals.

Download my goals worksheet

Prophylaxis with ADYNOVATE has helped some patients stay bleed free

In these ADYNOVATE clinical studies, patients receiving twice-weekly prophylaxis, ADYNOVATE demonstrated 2 bleeds or less per year in children and adults.^†

^†Data presented here are from 2 different trials and are based on median overall annualized bleed rate results.

Study description

Children under 12 years old
The pediatric study (N=73) evaluated the efficacy, PK, and safety of ADYNOVATE^® twice-weekly prophylaxis and determined the ability to treat bleeding episodes for 6 months. Sixty-six children (32 aged <6 years and 34 aged 6 to <12 years) received 40-60 IU/kg of ADYNOVATE prophylactically, twice-weekly. The primary goal of the study was to assess development of inhibitors to ADYNOVATE.^1,2

Adolescents and adults 12 years and older
A clinical trial of 137 previously treated patients (age 12 years and older) with severe hemophilia A evaluated how well ADYNOVATE worked over 6 months, in both twice-weekly prophylaxis and on-demand use. 120 patients received a prophylaxis dose of 40-50 IU/kg twice a week, and 17 patients received an on-demand dose of 10-60 IU/kg. The primary goal of the study was to compare the annualized bleed rates in the patients receiving prophylaxis and those receiving on-demand treatment.¹

Study results

In children under 12 years old

38%

(25 out of 66) of patients experienced zero bleeding episodes¹

73% of patients (48 of 66) experienced zero joint bleeds¹
67% of patients (44 of 66) experienced zero spontaneous bleeds¹

In adolescents and adults 12 years and older

40%

(40 out of 101 in the per-protocol group) of patients experienced zero bleeding episodes¹

57% of patients (68 of 120) experienced zero joint bleeds¹
57% of patients (69 of 120) experienced zero spontaneous bleeds³

Twice-weekly prophylaxis was proven to reduce Annual Bleed Rate (ABR)

Children under 12 years old (n=66)
experienced a

2.0

median overall ABR¹

ZERO median ABR for joint bleeds with prophylaxis (n=66)¹
ZERO median ABR for spontaneous bleeds with prophylaxis (n=66)¹

In adolescents and adults 12 years and older
(n=120) experienced a

1.9

median overall ABR¹

ZERO median ABR for joint bleeds with prophylaxis (n=120) versus 38.1 (n=17) with on-demand¹
ZERO median ABR for spontaneous bleeds with prophylaxis (n=120) versus 21.6 (n=17) with on-demand¹

SELECTED IMPORTANT RISK INFORMATION

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.

See Detailed Important Risk Information below.

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.

What is ADYNOVATE?

Proven bleed protection for children and adults

SELECTED IMPORTANT RISK INFORMATION

Get better organized by tracking your bleeds and infusions all in one place.

Go for it! Set and track your treatment, lifestyle, and overall health goals.

Prophylaxis with ADYNOVATE has helped some patients stay bleed free

SELECTED IMPORTANT RISK INFORMATION

Get better organized by tracking your
bleeds and infusions all in one place.

Go for it! Set and track your treatment,
lifestyle, and overall health goals.