Eloctate: Things To Know About This Long-Acting Medicine for Hemophilia A

• Eloctate is a long-acting recombinant factor VIII therapy used to treat hemophilia A in both children and adults.
• It works by replacing the missing factor VIII protein, which is essential for proper blood clotting.
• Eloctate is administered intravenously, and the dosage is determined by a healthcare provider based on factors like body weight and bleeding severity.
• Common side effects include joint/muscle pain, tiredness, headache, and rash, and there is a risk of developing inhibitors (antibodies) that can reduce the medication’s effectiveness.

Sanofi’s Eloctate is a long-acting antihemophilic factor (recombinant) used to treat hemophilia A in children and adults. It was approved by the FDA in June 2014. In this article, you will learn about its mechanism of action, dosage, side effects, cost, and more.

What Is Eloctate Used For?

Eloctate is a brand-name prescription product. It contains the active ingredient, recombinant clotting factor VIII, also called the recombinant antihemophilic factor. Eloctate belongs to a medication class called antihemophilic factors.

A healthcare provider may prescribe Eloctate for children and adults with hemophilia A to:

• Control and prevent bleeding episodes
• Prevent bleeding during surgery
• Reduce the frequency of bleeding episodes

In people with hemophilia A, blood doesn’t clot properly, as they have a coagulation factor VIII deficiency. Factor VIII deficiency increases the risk of unexplained bleeding or, in severe cases, potentially fatal internal bleeding.

Eloctate shouldn’t be used to treat another similar bleeding disorder called von Willebrand disease.

Eloctate Mechanism of Action

Eloctate injection contains a protein, which is made using recombinant DNA technology. This protein in Eloctate replaces the missing Factor 8 in children and adults with hemophilia A.

Eloctate Dosing

This medication comes as a sterile white to off-white powder for reconstitution for intravenous (IV) injection in single-dose vials.

The following strengths are available in the U.S.:

• 250 IU
• 500 IU
• 750 IU
• 1,000 IU
• 1,500 IU
• 2,000 IU
• 3,000 IU
• 4,000 IU
• 5,000 IU
• 6,000 IU

Before administering Eloctate for hemophilia, your healthcare provider will use a specific formula to determine the dose. Then, they will prepare the medication by following the instructions in the package insert.

The dose and duration of Eloctate treatment depend on:

• Body weight
• Severity of factor VIII deficiency
• Desired factor VIII level
• Location and extent of bleeding

A healthcare provider may adjust the dose for children younger than 6 years old. For individuals 6 years or older, dose adjustment isn’t usually necessary.

Eloctate Factor VIII Therapy Dosing for Control of Bleeding Episodes

Minor and moderate bleeding: 20 – 30 IU/kg IV to achieve factor VIII level of 40% – 60% of normal. Repeat every 24 – 48 hours until bleeding is resolved.

Major bleeding: 40 – 50 IU/kg IV to achieve factor VIII level of 80% – 100% of normal. Repeat Eloctate treatment every 12 – 24 hours until bleeding is resolved.

Eloctate Factor VIII Therapy Dosing for Preventing Bleeding During Surgery

Minor surgery: 25 – 40 IU/kg IV to achieve factor VIII level of 50% – 80% of normal. A repeat dose every 24 hours may be necessary for at least one day until healing is achieved.

Major surgery: 40 – 60 IU/kg IV before surgery to achieve a factor VIII level of 80% – 120% of normal. Repeat a dose of 40 – 50 IU/kg IV after 8 – 24 hours, then every 24 hours until the wound heals. Continue Eloctate treatment for at least one week.

Eloctate Factor VIII Therapy Dosing for Routine Prevention of Bleeding Episodes

• The recommended starting dose of Eloctate injections is 50 IU/kg IV every 4 days. The dosage may be adjusted depending on your response, with a dosing range of 25 – 65 IU/kg at 3 – 5 day intervals.
• For children younger than 6 years old diagnosed with hemophilia A, the recommended starting dose of Eloctate is 50 IU/kg IV twice weekly. The dosage may be adjusted depending on the response, with a dosing range of 25 – 65 IU/kg at 3 – 5 day intervals.

Eloctate Side Effects

Side effects of Eloctate can be mild or severe.

The most common side effects in previously treated individuals can include:

• Joint or muscle pain
• Tiredness
• Headache
• Rash

The most common side effects in previously untreated individuals can include:

• Inhibitor (antibody) production
• Rash
• Blood clots at the infusion site

Use During Pregnancy and Lactation

There are no human or animal studies about Eloctate use during pregnancy. It is unknown if this medication can harm an unborn baby or affect the ability to have a baby. Tell your healthcare provider if you’re pregnant or plan to get pregnant.

It is unknown if Eloctate factor 8 therapy passes into breast milk, harms the breastfed infant, or affects milk production. Tell your healthcare provider if you are breastfeeding.

Important Eloctate Warnings and Precautions

Allergic reactions

Eloctate injections may cause allergic reactions, which can be fatal. Seek emergency medical care if you experience:

• Hives
• Breathing difficulty
• Swelling in the face or throat

Inhibitor (Antibody) Production

In some cases, your body can make proteins called “inhibitors” or antibodies, which can stop this medication from working well.

If your immune system makes inhibitors, you will need special treatment to help control bleeding episodes. Talk to your healthcare provider to learn more about inhibitors and tests to measure your inhibitor level.

Before Taking Eloctate

Before you receive your first dose of Eloctate for hemophilia A, inform your provider if you:

• Are allergic to this product, any product component, or any other medications
• Have heart disease
• Have diseases of the blood vessels

Eloctate Cost

Cost can vary depending on your insurance plan, location, and pharmacy. Contact your insurance provider to find out if your plan covers this medication or if you need prior authorization.

Sanofi Corporation, the manufacturer of Eloctate, offers three financial assistance programs to help you access treatment:

• Free Trial Plus Program: With this program, you may be able to get your first 30-day supply within 24 – 48 hours with a valid prescription from your prescriber.
• Copay Program: Contact a Sanofi professional at 1-855-MyELOCTATE (1-855-693-5628) for more information.
• Factor Access Program: This program can help you access Eloctate factor VIII therapy even if your insurance is interrupted.

Click HERE to learn more about the programs mentioned above. Contact us to explore other financial assistance programs for Eloctate injections.

Eloctate Storage and Handling

Before preparing the solution

• Store in the original package to prevent exposure to sunlight.
• Maintain storage temperature between 2°C and 8°C (36°F and 46°F). Avoid freezing.
• You may store the Eloctate hemophilia medication at room temperature (maximum temperature 30°C or 86°F) for up to 6 months in a row. The expiration date should be printed on the label.
• If you store this medication at room temperature, record the date when it was removed from refrigeration.
• Once at room temperature, avoid returning the product to the refrigerator.
• Never use Eloctate beyond the expiration date printed on the vial or 6 months after storage at room temperature.

After preparing the solution

• You may store the solution at room temperature (maximum temperature 30°C or 86°F) for up to 3 hours. Avoid exposure to direct sunlight.
• Discard the solution if not used within 3 hours after reconstitution.
• Never use a solution that is cloudy or has particulate matter.
• Throw away any unused product.

Adynovate vs. Eloctate

According to a 2019 study, both products have almost identical properties. So, switching from Adynovate to Eloctate factor 8 therapy or vice versa doesn’t typically require changing the prophylaxis regimen [1].

How AmeriPharma® Specialty Pharmacy Can Help

At AmeriPharma® Specialty Pharmacy, we know that living with hemophilia A can be overwhelming. But you don’t have to navigate the complexities of treatment on your own.

Our URAC and ACHC-accredited specialty pharmacy is available 24/7 to provide personalized support, from handling insurance approvals to guidance through copy assistance programs, to make it easier for those with complex health conditions to receive the necessary treatments they need.

Contact us now to learn how we can support you on your hemophilia treatment journey.