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.

Established safety profile

Choosing a treatment for your hemophilia A is an important part of your overall health care plan. Learning and understanding the safety profile of certain treatments can play a major role in your decision.

Icon of 2 adults and 2 children. ADYNOVATE safety has been evaluated in 7 clinical studies in children and adults with severe hemophilia A.1

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 patients (children and adults) with severe hemophilia A who received at least 1 dose of ADYNOVATE in 3 completed, multicenter, prospective, open-label clinical studies and 4 ongoing clinical studies.

Study results

Icon of three people.Across 7 clinical studies,

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inhibitors to ADYNOVATE were reported in 237 previously treated patients1

  • In 191 adult and pediatric previously treated patients (PTPs) who were treated for at least 50 days with ADYNOVATE, zero factor VIII inhibitors developed1
  • One previously untreated patient (PUP) who received at least 1 infusion of ADYNOVATE did develop neutralizing antibodies to factor VIII1

Light bulb Icon.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 most 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.1

Collage of man throughout different stages of his life.

Talk to your healthcare provider about the safety information and side effects of treating with ADYNOVATE.

SELECTED IMPORTANT RISK INFORMATION

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.

See Detailed Important Risk Information below.

Treating twice-weekly

Find out if twice-weekly prophylaxis
treatment could be right for you.

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ADYNOVATE CoPay Program

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CoPay Program.

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