![ELOCTATE® (Antihemophilic Factor Recombinant), Fc Fusion Protein]](/Content/images/eloctate-logo.svg){kind=logo}
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.
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:
- 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
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).
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
CONTACT YOUR CoRe
Sanofi Hemophilia Community Relations and Education (CoRe) Managers offer education to people living with hemophilia and their families. CoRe Managers provide information about living with hemophilia and treatment options. Use our handy CoRe Locator to find the CoRe team member nearest you.
Get informed. Stay informed.
Let's stay in touch. We'll occasionally send you important information on Hemophilia A and ELOCTATE.
LET'S GET STARTEDELOCTATE® [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.
IMPORTANT SAFETY INFORMATION AND INDICATION
+
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.
INDICATION
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 INFORMATIONMANUFACTURED 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.
INDICATION
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.
MAT-US-2021871-v5.0-01/2023 Last Updated: January 2023