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.
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 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.
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.
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.
Consideration should be given to maintaining a Factor VIII activity at or above the target range.
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.
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 received ELOCTATE in one of three treatment arms:
In the Kids A-LONG study, patients age 1-11 received ELOCTATE in one of two treatment arms:
ELOCTATE is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for:
ELOCTATE is not indicated for the treatment of von Willebrand disease.
ELOCTATE 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 ELOCTATE Resources or call 1-855-ELOCTATE (1-855-693-5628).
Yes. Whether you're new to ELOCTATE or already on therapy, ELOCTATE offers a Copay Program that can cover up to $12,000 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-ELOCTATE (1-855-693-5628). Patients enrolled in Medicare, Medicaid or any other government healthcare program are ineligible from participating in the ELOCTATE copay program.
Yes. Receive your first 30-day supply of ELOCTATE immediately with a valid prescription from your healthcare provider. You may also be able to receive free factor for up to 1 year, if your healthcare insurance does not cover ELOCTATE. Find out more by calling 1-855-ELOCTATE (1-855-693-5628). Patients enrolled in Medicare, Medicaid or any other government healthcare program are ineligible from participating in the ELOCTATE free trial program.
Yes. The Factor Access program provides access to ELOCTATE, even if your insurance coverage is interrupted—for example, you are between jobs or changing insurers. Find out more by calling 1-855-ELOCTATE (1-855-693-5628). Patients enrolled in Medicare, Medicaid or any other government healthcare program are ineligible from participating in the ELOCTATE factor access program.
ELOCTATE is supplied in single-use vials containing nominally 250; 500; 750; 1000; 1500; 2000; 3000; 4000; 5000; or 6000 International Units (IU).
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.
Fc Fusion is the science behind ELOCTATE. To understand what Fc Fusion does, we first need to dive into a little biology. Your bloodstream contains many molecules, including proteins. Each protein has a specific job to do like build muscles, break down food, fight infection, or help stop bleeds like your replacement factor does.
ELOCTATE is the first recombinant factor to use a natural pathway to extend half-life and allow factor to remain in the body for a longer period of time following an infusion.
So, in summary, based on preclinical studies, it is believed that:
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 bothers you or does not go away, and if bleeding is not controlled after using ELOCTATE. Please visit Safety for more information.
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.
Community Relations and Education Managers (or CoRe, for short) live and work all across the United States. CoRe team members are parents, social workers, or people with hemophilia. They're available to answer your questions, educate, or just to talk. Use our handy CoRe Locator to find the CoRe team member nearest you.
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indications and important facts about eloctate
what is the most important information I should know about ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein]? You should not use ELOCTATE if you are allergic to ELOCTATE or any of its other ingredients. Tell your healthcare provider if you have had an allergic reaction to any Factor VIII product prior to using ELOCTATE.
Allergic reactions may occur. Call your healthcare provider or emergency department 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. This can stop ELOCTATE from working properly. Your healthcare provider may give you blood tests to check for inhibitors.
THE MOST COMMON SIDE EFFECTS OF ELOCTATE INCLUDE: headache, rash, joint pain, muscle pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider for more information and about any side effect that bothers you or does not go away.
WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE STARTING ELOCTATE?
Tell your healthcare provider about all your health conditions, including if you:
AFTER STARTING ELOCTATE:
If your bleeding is not controlled and you experience a lack of clinical response to Factor VIII therapy, call your healthcare provider right away.
Medicines are sometimes prescribed for purposes other than those listed here. Do not use ELOCTATE for a condition for which it was not prescribed. Do not share ELOCTATE with other people, even if they have the same symptoms that you have.
ELOCTATE 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.
HOW SHOULD I RECEIVE ELOCTATE?
ELOCTATE should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider. Many people with hemophilia A learn to infuse ELOCTATE by themselves or with the help of a family member. See the booklet called "Instructions for Use" packaged in your ELOCTATE for directions on infusing. If you are unsure of the procedure, please ask your healthcare provider.
IMPORTANT FACTS ABOUT ELOCTATE
Please read this information carefully before using ELOCTATE and each time you get a refill, as there may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
The risk information provided here is not comprehensive. To learn more, talk about ELOCTATE with your healthcare provider or pharmacist.
The FDA-approved product labeling can be found at www.eloctate.com or 1-855-MyELOCTATE (693-5628).
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.
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