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Frequently asked questions about ELOCTATE

It’s common to have questions when you’re learning about a different treatment option. Speaking with your healthcare provider is the best way to get all of the information you need when considering a change to a new factor. In the meantime, here are some answers to questions that you may have about ELOCTATE.

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What is ELOCTATE?
ELOCTATE is an 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 longer 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.
Can ELOCTATE prevent bleeds with infusions starting every 4 days?
In a clinical study, adult/adolescent patients infusing every 3 to every 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. 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.
What does it mean to have a factor level of 1% or greater?
People with a factor level of less than 1% have severe Hemophilia. People with 1% to 5% are considered to have moderate Hemophilia. People with a factor level from >5% to <40% are classified as having mild Hemophilia.1

Faq classification

Can ELOCTATE control bleeds?
In the A-LONG clinical study, 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.
See Control of Bleeds page.
How does ELOCTATE effectively treat bleeds?

Treatment of bleeds

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

What was the study design?
The safety and efficacy of ELOCTATE have been evaluated in previously treated patients with severe Hemophilia A in two completed studies (A-LONG and Kids A-LONG), and one ongoing extension study (n=233). 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 on-going extension study has enrolled a total of 211 patients (aged 2 to 66) who completed A-LONG or Kids A-LONG.
What is meant by the term “Previously Treated Patients” (PTPs) in the A-LONG study?
Previously Treated Patients, or PTPs, are people who have taken factor for their hemophilia for at least 150 exposure days before entering the ELOCTATE study.
What infusion schedules were studied with ELOCTATE?
ELOCTATE provides proven protection* from bleeds with a recommended infusion schedule starting from 4 days and adjusting to every 3-5 days based on your body’s individual response. In children under 6 years of age, ELOCTATE offers a prophylaxis infusion schedule starting twice weekly and may be adjusted at 3-5 day intervals. More frequent or higher doses may be required. In the pediatric clinical trial, ~90% of children under 12 years made no changes to their twice-weekly infusion schedule over the course of the study.

*ELOCTATE has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.
Who should use ELOCTATE?
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 von Willebrand disease
Does ELOCTATE offer a free trial program?
Yes. You may be eligible to receive a free 1-month trial of ELOCTATE with a prescription from your healthcare provider. If you and your healthcare provider decide to transition to ELOCTATE, this program may continue to offer free factor if your healthcare insurance does not cover ELOCTATE, for up to 1 year. Find out more by calling 1-855-MyELOCTATE (1-855-693-5628).
Does ELOCTATE offer a copay program?
Yes. The Copay Program offers savings up to $12,000 per year on out-of-pocket costs associated with your prescription of ELOCTATE. Program offers savings and is available for those eligble people who are new to ELOCTATE or already on therapy.
Am I eligible for financial assistance, and what benefits might I receive?
MyELOCTATE offers a wide array of services to those who are eligible. Apply to find out what assistance you might be eligible for. To find out more, visit MyELOCTATE™ Resources or call 1-855-MyELOCTATE (1-855-693-5628).
What vial sizes are available?
ELOCTATE is supplied in single-use vials containing nominally 250; 500; 750; 1000; 1500; 2000; or 3000 International Units (IU).
How is ELOCTATE made?
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.
What is Fc Fusion?
Fc Fusion is the science behind ELOCTATE. ELOCTATE is a recombinant Factor VIII FC fusion protein, consisting of a B-domain deleted factor VIII that is joined or fused to Fc. Fc is normally found as part of the commonly found protein in your body. ELOCTATE temporarily binds to a specific receptor in your body. The binding is thought to redirect ELOCTATE back toward the bloodstream, away from where it would otherwise be broken down.
What are some of the risks with ELOCTATE?
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. The most frequently occurring side effects of ELOCTATE are headache, rash, joint pain, muscle pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider about any side effect that is a concern or does not go away, and if bleeding is not controlled after using ELOCTATE. Please visit Safety for more information.
Will changing factors increase the risk of getting an inhibitor?
ELOCTATE has been evaluated for safety in 233 previously treated patients who received at least one dose in A-LONG (n=164), Kids A-LONG (n=69), and ASPIRE (n=211). 136 subjects were treated for at least 104 weeks. There were zero inhibitors in the ELOCTATE adult, adolescent, and pediatric clinical studies. In A-LONG, one person had a transient, positive neutralizing antibody that was not confirmed upon repeat testing. Inhibitors to Factor VIII can occur following administration of ELOCTATE. Your healthcare provider may give you blood tests to check for inhibitors.
What are important questions to ask my healthcare provider about transitioning to ELOCTATE?
Every question is an important one, especially when you want to learn more about a different treatment.
The Doctor Discussion Guide can help you know what questions to ask about ELOCTATE.

Reference 1. White GC, Rosendaal F, Aledort LM, et al. Recommendations of the scientific subcommittee on factor VIII and factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Thromb Haemost; 2001. 85:560.

Indications and Important Safety Information

Indications

ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] 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, and routine prophylaxis to reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease.

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.

The most frequently occurring side effects of ELOCTATE are headache, rash, joint pain, muscle pain and general discomfort. 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, and if bleeding is not controlled after using ELOCTATE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.

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