Understanding inhibitors

Your body may form inhibitors to factor VIII. Inhibitors are antibodies and part of the body’s normal defense system against disease. If you form inhibitors, it may stop ADYNOVATE from working properly. Talk with your HCP to make sure you are monitored with blood tests for the development of inhibitors to factor VIII.¹

Study description

Pooled safety data evaluation
The safety of ADYNOVATE was evaluated in 478 previously treated patients (PTPs) and previously untreated patients (PUPs) with severe hemophilia A who received at least one dose of ADYNOVATE in 7 clinical studies.

Study results

Across 7 clinical studies,

Inhibitors Seen in 365 Previously Treated Patients at Completion of 6 Clinical Studies¹

2 PTPs developed a temporary FVIII inhibitor while receiving ADYNOVATE^1†

^†Only one of these cases was confirmed with repeat testing. Both of the patients continued treatment without change in the dose of ADYNOVATE.

From a clinical study with 120 previously untreated patients with severe hemophilia A, 11 of 100 evaluable patients developed inhibitors associated with ADYNOVATE treatment after an average of 7.6 exposure days* to ADYNOVATE.

*An exposure day is any 24-hour period where the patient receives at least one infusion of FVIII concentrate.

What are PTPs and PUPs?

What are PTPs?
In these ADYNOVATE clinical studies, previously treated patients (PTPs) represent patients who have had either >50 or >150 exposure days (EDs) to factor VIII products.¹

What are PUPs?
In these ADYNOVATE clinical studies, previously untreated patients (PUPs) represent patients who have not had exposure to a factor VIII product at the time they were enrolled in the study.¹

SELECTED IMPORTANT RISK INFORMATION

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.

See Detailed Important Risk Information continued below.

Adverse reactions

The common side effects of ADYNOVATE are cough, headache, diarrhea, vomiting, rash, nausea, hives, and dizziness. 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.

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 adults and children 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 pregnant or planning to 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 cough, headache, diarrhea, vomiting, rash, nausea, hives, and dizziness. 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.

What is ADYNOVATE?

Established safety profile

Understanding inhibitors

SELECTED IMPORTANT RISK INFORMATION

Adverse reactions