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.

Additional common side effects of ELOCTATE are headache, rash, joint pain, muscle pain and general discomfort.

If you have risk factors for developing abnormal blood clots in your body, such as an indwelling venous catheter, treatment with Factor VIII may increase this risk.

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, or if bleeding is not controlled after using ELOCTATE.

INDICATIONS

ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] 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.

MANUFACTURED BY

Bioverativ Therapeutics Inc.
Waltham, MA 02451 USA
U.S. License #2078

CLICK HERE TO LEARN MORE ABOUT SANOFI'S COMMITMENT TO FIGHTING COUNTERFEIT DRUGS.