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.

Ellipse

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

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 greater than 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, or if you're already on ELOCTATE, we'll send you a stylish cooler bag.

Bluetooth is a registered trademark of Bluetooth SIG, Inc.

Bluetooth is a registered trademark of Bluetooth SIG, Inc.

×

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.

Important Safety Information and Indication  INFORMACIÓN DE SEGURIDAD IMPORTANTE INDICACIONES 

IMPORTANT SAFETY INFORMATION INFORMACIÓN DE SEGURIDAD IMPORTANTE INDICACIONES

Do not use ELOCTATE if you have had an allergic reaction to it in the past. No use ELOCTATE si ha tenido una reacción alérgica a este en el pasado.

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. Informe a su proveedor de atención médica si tiene o ha tenido algún problema médico; toma algún medicamento, incluidos medicamentos recetados y de venta libre, suplementos o medicamentos a base de hierbas; tiene alergias; está en período de lactancia; está embarazada o tiene intención de quedar embarazada; o si le han indicado que tiene inhibidores (anticuerpos) del factor VIII.

INDICATION INDICACIONES

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. ELOCTATE® es un medicamento inyectable que se usa para ayudar a controlar y prevenir la hemorragia en personas con hemofilia A (deficiencia congénita del factor VIII). Su proveedor de atención médica le podría recetar ELOCTATE cuando se opere.

Important Safety Information and Indication  INFORMACIÓN DE SEGURIDAD IMPORTANTE INDICACIONES 

IMPORTANT SAFETY INFORMATION INFORMACIÓN DE SEGURIDAD

Do not use ELOCTATE if you have had an allergic reaction to it in the past. No use ELOCTATE si ha tenido una reacción alérgica a este en el pasado.

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. Informe a su proveedor de atención médica si tiene o ha tenido algún problema médico; toma algún medicamento, incluidos medicamentos recetados y de venta libre, suplementos o medicamentos a base de hierbas; tiene alergias; está en período de lactancia; está embarazada o tiene intención de quedar embarazada; o si le han indicado que tiene inhibidores (anticuerpos) del 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. Pueden producirse reacciones alérgicas con ELOCTATE. Llame a su proveedor de atención médica o busque tratamiento de emergencia inmediatamente si presenta alguno de los siguientes síntomas: dificultad para respirar, opresión en el pecho, hinchazón de la cara, erupciones o urticaria.

Your body can also make antibodies called "inhibitors" against ELOCTATE, which may stop ELOCTATE from working properly. Su organismo también puede producir anticuerpos denominados “inhibidores” contra ELOCTATE, que pueden impedir que este actúe correctamente.

Additional common side effects of ELOCTATE are headache, rash, joint pain, muscle pain and general discomfort. Los efectos secundarios frecuentes adicionales de ELOCTATE son dolor de cabeza, erupciones, dolor articular, dolor muscular y malestar general.

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. Si tiene factores de riesgo para el desarrollo de coágulos sanguíneos anómalos en su cuerpo, como un catéter venoso permanente, es posible que el tratamiento con factor VIII aumente este riesgo.

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. Estos no son todos los efectos secundarios posibles de ELOCTATE. Hable inmediatamente con su proveedor de atención médica sobre cualquier efecto secundario que le moleste o persista, o si la hemorragia no se controla después de usar ELOCTATE.

INDICATION INDICACIONES

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. ELOCTATE® es un medicamento inyectable que se usa para ayudar a controlar y prevenir la hemorragia en personas con hemofilia A (deficiencia congénita del factor VIII). Su proveedor de atención médica le podría recetar ELOCTATE cuando se opere.

Please see Full Prescribing Information

CONSULTE LA INFORMACIÓN DE PRESCRIPCIÓN COMPLETA en inglés

POR FAVOR VER LA INFORMACIÓN DEPRESCRIPCIÓN COMPLETA en español

MANUFACTURED BY FABRICADO PARA

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

Click here to learn more about Sanofi's commitment to fighting counterfeit drugs. HAGA CLIC AQUÍ PARA OBTENER MÁS INFORMACIÓN SOBRE EL COMPROMISO DE SANOFI PARA COMBATIR LOS MEDICAMENTOS FALSIFICADOS.