whoa. whoa. whoa.

You're being directed to the ELOCTATE Healthcare Professional website. If you're okay with that, we're okay with that.

Come back soon!

Clinical Study Design

A little more detail on ELOCTATE clinical trial study design:

The efficacy of ELOCTATE has been studied longer than any other Factor VIII with an extended half-life. Evaluated in previously treated patients with severe Hemophilia A in three clinical studies: A-LONG, Kids A-LONG, and ASPIRE extension study.

4 Percent

PHARMACOKINETICS

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 patients (ages 1-11). The adult subgroup included two adolescent subjects (a 15- and 16-year old).

164 people (AGE 12-65)

In the A-LONG study, patients received ELOCTATE in 1 of 3 treatment arms:

The efficacy and safety of ELOCTATE has been studied longer than any FACTOR VIII with an extended half-life. Evaluated in previously treated patients with severe Hemophilia A in two completed studies (A-LONG and Kids A-LONG), and one extension study (n=233).

  • Individualized Prophylaxis: Every 3 to every 5 days (dose or interval could be adjusted to maintain appropriate FVIII levels)
  • Weekly prophylaxis
  • On demand for bleeding episodes

69 people (AGE 1-11)

In the Kids A-LONG study, patients received ELOCTATE in one treatment arm:

  • Individualized Prophylaxis: Twice-weekly (dose or interval could be adjusted to maintain appropriate FVIII levels)

211 people (AGE 1-65)

The ASPIRE extension study included people who completed A-LONG or Kids A-LONG

  • 179 adults and adolescents 12 years and older.
  • 61 patients less than 12-years-old

Get informed. Stay informed.

Let's stay in touch. We’ll occasionally send you important information on Hemophilia A and ELOCTATE. If you're new to ELOCTATE, we’ll send you a Bluetooth® speaker so you can listen to patient stories.

Bag/Speaker
Bluetooth is a registered trademark of Bluetooth SIG, Inc. All rights reserved.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

+

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.

PLEASE SEE FULL PRESCRIBING INFORMATION

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.