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Proven protection*

from bleeds

MEDIAN BLEED RATES FROM PROPHYLAXIS INFUSIONS

*ELOCTATE has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.

SELECTED IMPORTANT SAFETY INFORMATION

  • 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.

Please see below for additional Important Safety Information and full Prescribing Information.

“Since starting ELOCTATE,
I have not yet had
any spontaneous bleeds.”
— Rick, on ELOCTATE.
Note: This is a personal account of a MyELOCTATE Peer™. Please talk to your healthcare provider about whether ELOCTATE may be right for you. Individual results may vary.
STUDY DESIGN
The safety and efficacy of ELOCTATE have been evaluated in previously treated patients with severe Hemophilia A in two completed studies (A-LONG and Kids A-LONG), and one ongoing extension study (n=233). A total of 164 patients in A-LONG (aged 12-65) received ELOCTATE in one of three treatment arms: every 3 to every 5 days (dose or interval could be adjusted to maintain appropriate FVIII levels), weekly prophylaxis, or on-demand. In Kids A-LONG, a total of 69 patients (aged 1-11) received ELOCTATE twice-weekly (dose or interval could be adjusted to maintain appropriate FVIII levels) or on-demand. The on-going extension study has enrolled a total of 211 patients (aged 2 to 66) who completed A-LONG or Kids A-LONG.

Indications and Important Safety Information

Indications

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.

Please see full Prescribing Information.

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