Adynovate: A Long-Lasting Medication for Hemophilia A Patients

FDA-approved in November 2015, Takeda’s Adynovate is a twice-weekly treatment for hemophilia A in children and adults. 

What Is Adynovate?

Adynovate is a brand-name prescription medication. The active substance in this product is recombinant clotting factor VIII (recombinant antihemophilic factor). It is in a class of medications called antihemophilic factors. The term “recombinant” means this product is made in a lab with recombinant DNA technology instead of being sourced from blood donors. As a result, Adynovate doesn’t have a risk of spreading blood-borne infections.

People with hemophilia A are missing the blood clotting factor called factor VIII. This results in the blood not clotting, leading to a higher risk of unexplained bleeding or, in severe cases, potentially life-threatening internal bleeding. 

How Is Adynovate Supplied and Used?

This product comes as a sterile, white to off-white powder for reconstitution for intravenous (IV) injection in single-dose vials. One international unit (IU) is equal to the quantity of factor VIII in 1 ml of fresh human plasma. The following strengths are available in the US:

• 250 IU
• 500 IU
• 750 IU
• 1,000 IU
• 1,500 IU
• 2,000 IU
• 3,000 IU

Before administering the medication, your healthcare provider will determine the dose using a specific formula. Then, they will prepare the liquid for injection following instructions on the package. 

The dose and duration of treatment depend on:

• Body weight
• Severity of factor VIII deficiency
• Desired factor VIII level
• Location and severity of bleeding
• Condition you’re receiving the infusion for

Adynovate is given as an injection into the veins (IV). It’s typically given twice per week for bleeding prevention and every 8 to 24 hours for bleeding treatment, depending on how severe the bleeding is.

The medication is typically administered over a period of 5 or fewer minutes. The liquid should be used within 3 hours after reconstitution. 

How Does Adynovate Work?

This medicine works by replacing the missing clotting factor VIII in children and adults with hemophilia A. 

What Is Adynovate Used To Treat?

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

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

This product isn’t used to treat another similar bleeding disorder called von Willebrand disease.

What Are the Side Effects of Adynovate?

Side effects can range from mild to severe. 

The most common side effects are:

• Headache
• Diarrhea
• Rash
• Nausea
• Dizziness 
• Hives

Talk to your healthcare provider if these side effects don’t go away or worsen. 

Some people receiving Adynovate may experience severe allergic reactions, including anaphylaxis. Anaphylaxis is a potentially fatal reaction that causes difficulty breathing and low blood pressure. Go to the emergency room  if you develop the following symptoms after receiving Adynovate:

• Rash and itching
• Hoarseness
• Breathing difficulty
• Trouble swallowing
• Swelling of your hands, face, or mouth

In some people, their immune system makes proteins called inhibitors after receiving the medication. Inhibitors can make Adynovate less effective in stopping a bleeding episode. 

If you develop inhibitors, you will need special treatment until your immune system no longer makes inhibitors. Talk to your healthcare provider to learn more about inhibitors and tests to measure your inhibitor level. 

Who Shouldn’t Receive This Medication?

People allergic to recombinant factor VIII, mouse or hamster protein, or any product component shouldn’t use Adynovate. Make sure to tell your healthcare provider about any known allergies you have. 
 

Use in Pregnancy and Lactation

There are no human or animal data about use during pregnancy. It isn’t known if this medication can harm an unborn baby. 
Likewise, it isn’t known if this medication passes into breast milk or if it harms the breastfed infant. Talk to your healthcare provider about the risks and benefits of using this medication if you are pregnant or nursing a child.
 

Can You Self-Administer Adynovate?

If your healthcare provider has trained you to self-administer this medication at home, remember the following:

• Use Adynovate exactly as directed. 
• Follow all directions on the prescription label. 
• Never use this medication in larger or smaller quantities or for longer than recommended. 
• Be sure to check the strength of the medicine on the label. 
• Don’t self-administer if you don’t understand how to use the injection.
• Always use sterile water and a reconstitution device that comes with the product to prepare the solution for injection. 
• Don’t refrigerate the liquid after reconstitution. 
• Use the liquid within 3 hours after reconstitution.
• Before using your dose, visually check the solution. It should be clear and colorless. 
• Discard the liquid that isn’t clear or contains particles. 
• A single-use vial, as the name suggests, is for one use only. 
• Put the needle, syringe, and Adynovate in a puncture-proof sharps container before disposing. Don’t dispose of any of them in ordinary household trash.
• Keep the container away from children and pets.
• You may need frequent blood tests to check if the treatment is working or if you need to change your doses. 

What Happens If I Miss a Dose?

Because this medicine is administered when needed, a dosing schedule is unlikely. However, if you are on a schedule, take the missed dose as soon as you remember. Skip the missed dose if it is time for the next scheduled dose. Never use extra medicine to compensate for the missed dose.
 

Adynovate vs. Advate: What’s the Difference?

Both medications contain the same active substance, recombinant clotting factor VIII. Additionally, both Adynovate and Advate are used to treat hemophilia A. 
However, Adynovate contains a substance that extends its half-life. A longer half-life means the medication stays in your system longer, which allows for a twice-weekly dosing schedule. 
 

Adynovate vs. Adynovi: What’s the Difference?

Adynovate is marketed as Adynovi in Europe. Both products contain the same active and inactive components.
 

How Much Does Adynovate Cost?

The amount you pay for Adynovate treatment can vary, depending on your insurance plan, geographical location, and pharmacy. Contact your insurance provider to find out if your plan covers this medicine or if you need prior authorization.
According to Takeda Pharmaceuticals U.S.A., which makes Adynovate, over 90% of commercial and Medicaid health plans cover this medicine. 
If your provider has prescribed this medicine, you may be eligible for Takeda’s HSC Co-Pay Assistance Program, which can cover up to 100% of your out-of-pocket copay costs.
New users may be eligible for 8 free trial doses with Takeda’s FREEDOM OF CHOICE program. 
Contact us below to learn more about financial assistance for Adynovate.