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

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. 

Eloctate Uses

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

A healthcare provider may prescribe this medication 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 coagulation factor VIII deficiency. Factor VIII deficiency increases the risk of unexplained bleeding or, in severe cases, potentially fatal internal bleeding. 

This medication 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 replaces the missing Factor VIII in children and adults with hemophilia A. 

Eloctate Dosage

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 this medication, 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 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. 

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 every 12 – 24 hours until bleeding is resolved. 

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 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 treatment for at least one week. 

Dosing for routine prevention of bleeding episodes

• The recommended starting dose 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, the recommended starting dose 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 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 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 this medication 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

This medication 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, 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 even if your insurance is interrupted. 

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

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 this 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 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 one product to another doesn’t typically require changing the prophylaxis regimen [1].