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5 days with factor

levels above 1%

Adult patients maintained factor levels above 1% for an average of 5 days — which means an average of 5 days with factor levels above the minimum threshold for patients with severe Hemophilia A*.

In adults (n=28), after single dose of 50 IU/kg, Mean days=5.10 95% Confidence Interval =4.54 TO 5.66.

Pediatric Information
Pharmacokinetic studies in children aged 1 to 5 have demonstrated a shorter half-life and higher clearance of factor VIII compared to adults. Therefore a higher dose or more frequent dosing may be needed in this age group.

*Guidelines of the National Hemophilia Foundation's (NHF) Medical and Scientific Advisory Council (MASAC #179) recommend that prophylaxis therapy for Hemophilia A be instituted with the aim of keeping factor levels above 1% between doses.

SELECTED IMPORTANT SAFETY INFORMATION

  • 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.

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

STUDY DESIGN
The pharmacokinetics of ELOCTATE were evaluated following a single dose of 50 IU/kg in the Phase 3 study of 28 adult and 11 adolescent (ages 12-17), previously treated patients and in an open-label, multicenter study of 54 pediatric (ages 1-11), previously treated patients. The adult subgroup included two adolescent subjects (15 and 16 years old).

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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