Frequently Asked Questions

Frequently Asked Questions

You've got questions?
Here are some answers.

If you don’t see your question here, talk to your doctor or contact your Community Relations and Education (CoRe) Manager. You can locate yours here.

Always consult your doctor with any questions about your health or treatment.

Q Q

What is Hemophilia A, of Factor VIII Deficiency?

A A

Hemophilia A, also called factor VIII deficiency, means you are missing or have low levels of clotting Factor VIII, which can result in prolonged bleeding episodes occuring after injuries or surgery.*

*https://www.ncbi.nlm.nih.gov/books/NBK1401/#hemo-a.Clinical_Characteristics

Q Q

How can I replace missing factor?

A A

You can replace missing factor by infusing Factor VIII to decrease risk of bleeding or help resolve a bleed.*

*https://www.ncbi.nlm.nih.gov/books/NBK1401/#hemo-a.Clinical_Characteristics

Q Q

What is ELOCTATE?

A A

ELOCTATE is an intravenous (IV) prescription medicine that is indicated to help control and prevent bleeding episodes in people with Hemophilia A. With ELOCTATE, factor remains in your system for an extended period of time because it is thought to use a natural process to temporarily delay the factor from breaking down and redirect the factor back into the bloodstream.

Q Q

Can ELOCTATE prevent bleeds with a dosing interval of 5 days?

A A

In a clinical study, some patients dosed every 5 days. Adults and adolescent patients infusing every 3 to 5 days experienced an average of 1.6 bleeds per year. Those patients infusing on-demand experienced 33.6 bleeds per year. The recommended starting regimen of ELOCTATE is every 4 days at 50 IU/kg, with adjustments to every 3 to every 5 days and in the range of 25 IU/kg to 65 IU/kg depending on each patient's response. For children under 6 years of age, the recommended starting regimen is 50 IU/kg of ELOCTATE administered twice weekly. Adjust the regimen based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals. More frequent or higher doses up to 80 IU/kg may be required. Talk to your healthcare provider about what infusion schedule may be right for you.

Q Q

What does it mean to have a factor level of 1% or greater?

A A

People with a factor level of less than 1% have severe Hemophilia A. People with 1% to 5% are considered to have moderate Hemophilia A. People with a factor level from >5% to < 40% are classified as having mild Hemophilia A.

Bleed Control Table Bleed Control Table

Q Q

Can ELOCTATE control bleeds when they occur?

A A

In the A-LONG clinical study with adults and adolescents, 98% of bleeds were controlled with 1 or 2 infusions of ELOCTATE. In the Kids A-LONG study, 93% of bleeds were controlled with 1 or 2 infusions of ELOCTATE.

Q Q

What dosing regimens does ELOCTATE offer to treat bleeds?

A A
Bleed Control Bleed Control

Consideration should be given to maintaining a Factor VIII activity at or above the target range.


Always follow your doctor's advice on specific dosing.

Q Q

What was the study design?

A A

The efficacy of ELOCTATE in previously treated patients with severe Hemophilia A has been evaluated in two with severe Hemophilia A in two completed studies (A-LONG and Kids A-LONG), and one extension study. 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 that 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 that could be adjusted to maintain appropriate FVIII levels) or on-demand. The extension study enrolled a total of 240 patients (aged 2 to 66) who completed A-LONG or Kids A-LONG.

Q Q

What is meant by the term “Previously Treated Patients” (PTPs) in the A-LONG study?

A A

Previously Treated Patients, or PTPs, are people who have taken factor for their Hemophilia A for at least 150 exposure days before entering the ELOCTATE study.

Q Q

What infusion schedules were studied with ELOCTATE?

A A

In the A-LONG study, patients 12 and over received ELOCTATE in one of three treatment arms:

  • Every 3 to every 5 days with dose or interval that could be adjusted to maintain appropriate Factor VIII levels
  • Weekly prophylaxis
  • On-demand

In the Kids A-LONG study, patients age 1-11 received ELOCTATE in one of two treatment arms:

  • Twice-weekly (dose or interval that could be adjusted to maintain appropriate Factor VIII levels)
  • On-demand

Q Q

Who should use ELOCTATE?

A A

ELOCTATE 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
  • Routine prophylaxis to reduce the frequency of bleeding episodes

ELOCTATE is not indicated for the treatment of von Willebrand disease.

Q Q

Am I eligible for financial assistance, and what benefits might I receive?

A A

ELOCTATE offers a wide array of services to those who are eligible. To find out more, visit ELOCTATE Resources or call 1-855-MYELOCTATE (1-855-693-5628).

Q Q

Does ELOCTATE offer a copay program?

A A

Yes. Whether you're new to ELOCTATE or already on therapy, ELOCTATE offers a Copay Program that can cover up to $20,000 of out-of-pocket, co-payment or co-insurance costs associated with your prescription. Best of all, there are no income requirements or caps. Find out more by calling 1-855-MYELOCTATE (1-855-693-5628).

Not valid where prohibited by law. Sanofi Genzyme reserves the right to modify or discontinue the programs at any time. Program details provided upon registration. Free Trial Plus and Copay Program not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DoD, TRICARE®, or similar federal or state programs including any state pharmaceutical assistance programs. Copay program savings may vary depending on patients’ out-of-pocket costs.

TRICARE is a registered trademark of the Department of Defense, Defense Health Agency (DHA).

Q Q

Does ELOCTATE offer a free trial program?

A A

Yes. Receive your first 30-day supply of ELOCTATE immediately with a valid prescription from your healthcare provider. You may also be eligible to receive free factor for a limited period of time, while Patient Services addresses your factor access issue. Find out more by calling 1-855-MYELOCTATE (1-855-693-5628).

Not valid where prohibited by law. Sanofi Genzyme reserves the right to modify or discontinue the programs at any time. Program details provided upon registration. Free Trial Plus and Copay Program not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DoD, TRICARE®, or similar federal or state programs including any state pharmaceutical assistance programs. Copay program savings may vary depending on patients’ out-of-pocket costs.

TRICARE is a registered trademark of the Department of Defense, Defense Health Agency (DHA).

Q Q

Can I continue to receive ELOCTATE if I lose my insurance?

A A

Yes. The Factor Access program may be able to help you access ELOCTATE, even if your insurance coverage is interrupted—for example, you are between jobs or changing insurers. Find out more by calling 1-855-MYELOCTATE (1-855-693-5628). Not valid where prohibited by law. Sanofi Genzyme reserves the right to modify or discontinue the programs at any time. Program details provided upon registration.

Q Q

What vial sizes are available?

A A

ELOCTATE is supplied in single-use vials containing nominally 250; 500; 750; 1000; 1500; 2000; 3000; 4000; 5000; or 6000 International Units (IU).

Q Q

How is ELOCTATE made?

A A

ELOCTATE is a recombinant Factor VIII, produced by DNA technology in the HEK (Human Embryonic Kidney) cell line. No human or animal proteins are used in the purification or formulation processes. Our state-of-the-art facilities follow strict purity and quality standards in all stages of manufacturing. The process also includes a detergent viral inactivation step and a 15 nm filtration step.

Q Q

What is Fc Fusion?

A A

Just as the blades of a windmill harness naturally occurring wind to produce energy, Fc Fusion utilizes naturally occurring Fc receptors in your body to keep Factor VIII temporarily recirculating in your bloodstream. ELOCTATE is Factor VIII fused with an Fc protein.

Q Q

What are some of the risks with ELOCTATE?

A A

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. Please visit Safety for more information.

Q Q

What are important questions to ask my healthcare provider about transitioning to ELOCTATE?

A A

Every question is an important one, especially when you want to learn more about a different treatment. The Doctor Discussion section can help you prepare for your next discussion with your healthcare team. It also provides a downloadable guide to take into your appointment.

Got more questions? Contact your CoRe.

Sanofi Genzyme 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.

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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

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