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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.^*

^*ncbi.nlm.nih.gov/books/NBK1401/#hemo-a.Clinical_Characteristics

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

^*ncbi.nlm.nih.gov/books/NBK1401/#hemo-a.Clinical_Characteristics

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.

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.

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.

ELOCTATE is a recombinant DNA-derived, antihemophilic Factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for:

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

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

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.

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.

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 an average of 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.

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.

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.

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.

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

The efficacy of ELOCTATE in previously treated patients with severe Hemophilia A has been evaluated 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 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 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.

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.

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 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 could be adjusted to maintain appropriate Factor VIII levels)
• On-demand

Yes. Receive your first 30-day supply of ELOCTATE within 24 to 48 hours with a valid prescription from your healthcare provider. While you and your doctor are deciding what treatment is right for you, your dedicated Sanofi professional will review your health insurance information. Enroll online and a dedicated Sanofi professional will contact you within 24 hours.*

*The Free Trial Plus Program is not valid for patients enrolled in Medicare, Medicaid, VA, DoD, TRICARE^®, or similar federal or state Programs including any state pharmaceutical assistance programs. The program is not valid where prohibited by law. Sanofi reserves the right to modify or discontinue the Programs at any time without notice. Program details will be provided upon registration.

Yes. Pay as little as $0 with maximum annual savings up to $20,000 with no income caps. Get your Copay card by enrolling online or by contacting your dedicated Sanofi professional at 1-855-MYELOCTATE.*

The Copay Program is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DoD, TRICARE^®, or similar federal or state Programs including any state pharmaceutical assistance programs. This program is not valid where prohibited by law. Sanofi reserves the right to modify or discontinue the program at any time without notice. Copay program savings may vary depending on patients' out-of-pocket costs. Program details will be provided upon registration.

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).

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 reserves the right to modify or discontinue the at any time. Program details provided upon registration.