what is the most important information I should know about ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein]? You should not use ELOCTATE if you are allergic to ELOCTATE or any of its other ingredients. Tell your healthcare provider if you have had an allergic reaction to any Factor VIII product prior to using ELOCTATE.
Allergic reactions may occur. Call your healthcare provider or emergency department 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. This can stop ELOCTATE from working properly. Your healthcare provider may give you blood tests to check for inhibitors.
THE MOST COMMON SIDE EFFECTS OF ELOCTATE INCLUDE: headache, rash, joint pain, muscle pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider for more information and about any side effect that bothers you or does not go away.
WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE STARTING ELOCTATE?
Tell your healthcare provider about all your health conditions, including if you:
- Have or have had any medical problems.
- Are taking any prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal medicines.
- Are pregnant or planning to become pregnant. It is not known if ELOCTATE may harm your unborn baby.
- Are breastfeeding. It is not known if ELOCTATE passes into breast milk or if it can harm your baby.
AFTER STARTING ELOCTATE:
If your bleeding is not controlled and you experience a lack of clinical response to Factor VIII therapy, call your healthcare provider right away.
Medicines are sometimes prescribed for purposes other than those listed here. Do not use ELOCTATE for a condition for which it was not prescribed. Do not share ELOCTATE with other people, even if they have the same symptoms that you have.
ELOCTATE is an injectable medicine that is used to help control and prevent bleeding in people with Hemophilia A (congenital Factor VIII deficiency).
Your healthcare provider may give you ELOCTATE when you have surgery.
HOW SHOULD I RECEIVE ELOCTATE?
ELOCTATE should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider. Many people with hemophilia A learn to infuse ELOCTATE by themselves or with the help of a family member. See the booklet called "Instructions for Use" packaged in your ELOCTATE for directions on infusing. If you are unsure of the procedure, please ask your healthcare provider.
IMPORTANT FACTS ABOUT ELOCTATE
Please read this information carefully before using ELOCTATE and each time you get a refill, as there may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
The risk information provided here is not comprehensive. To learn more, talk about ELOCTATE with your healthcare provider or pharmacist.
The FDA-approved product labeling can be found at www.eloctate.com or 1-855-MyELOCTATE (693-5628).
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.
Please see Full Prescribing Information
Bioverativ Therapeutics Inc.
Waltham, MA 02451 USA
U.S. License #2078