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.
ADYNOVATE safety has been evaluated in 7 clinical studies in children and adults with severe hemophilia A.1
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
Pooled safety data evaluation
The safety of ADYNOVATE was evaluated in 365 patients (children and adults) with severe hemophilia A who received at least 1 dose of ADYNOVATE in 6 completed multi-center, prospective, open label clinical studies and 1 ongoing clinical study.
Across 7 clinical studies,
Inhibitors Seen in Previously Treated Patients at Completion of 6 Clinical Studies1
1 PTP developed a temporary FVIII inhibitor while receiving more frequent dosing on ADYNOVATE1†
1 PTP from an extension study developed a temporary FVIII inhibitor1†
†Repeat testing did not confirm the presence of inhibitor. Both of the patients continued treatment without change in the dose of ADYNOVATE.
From an ongoing study in previously untreated patients less than 6 years old with severe hemophilia A, 9 cases of inhibitors to ADYNOVATE were reported.
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.
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.1
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.
Find out if twice-weekly prophylaxis treatment could be right for you.
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.