Safety Data from
the clinical trials
ELOCTATE has been evaluated for safety in 233 previously treated patients who received at least one dose in A-LONG (n=164), Kids A-LONG (n=69), and ASPIRE (n=211). 136 subjects were treated for at least 104 weeks.
ZERO INHIBITORS IN THE ADULT, ADOLESCENT, AND PEDIATRIC CLINICAL STUDIES
- In the adult study one person had a transient, positive neutralizing antibody that was not confirmed upon repeat testing
- Inhibitors to Factor VIII can occur following administration of ELOCTATE. Your healthcare provider may give you blood tests to check for inhibitors
ADVERSE REACTIONS IN THE CLINICAL STUDIES
Most frequently occurring adverse reactions in the clinical studies were headache, rash, joint pain, muscle pain and general discomfort; each occurred in
Abdominal pain (lower), back pain, altered sense of taste, chest pain, cough, dizziness, feeling cold, feeling hot, headache, high blood pressure, joint swelling, muscle pain, procedural low blood pressure, rash, slow heart rate, and vascular pain after injection of drug; each occurred in
withdrew from the study due to adverse reactions (one individual for a rash, and one for joint pain)
DOCTOR DISCUSSION GUIDE
Any question you have is an important one — especially when considering treatment options for Hemophilia A.
Whether you've had a discussion with your Healthcare Provider about ELOCTATE and your needs have changed or, it's your first time talking about ELOCTATE, our Doctor Discussion Guide can help you prepare. So you can make an informed choice, together, about what's right for you.
Indications and Important Safety Information
ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease.
Important Safety Information
Do not use ELOCTATE if you have had an allergic reaction to it in the past.
Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies, are breastfeeding, are pregnant or planning to become pregnant, or have been told you have inhibitors (antibodies) to Factor VIII.
Allergic reactions may occur with ELOCTATE. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.
Your body can also make antibodies called, "inhibitors," against ELOCTATE, which may stop ELOCTATE from working properly.
The most frequently occurring side effects of ELOCTATE are headache, rash, joint pain, muscle pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider right away about any side effect that bothers you or that does not go away, and if bleeding is not controlled after using ELOCTATE.
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.