Altuviiio: A Once-Weekly Treatment for Hemophilia A

FDA-approved in February 2023, Sanofi’s Altuviiio is a long-acting antihemophilic factor (recombinant) used to treat hemophilia A in children and adults. Learn about its mechanism of action, dosage, side effects, cost, and more. 

Important Warnings and Precautions

Allergic Reactions

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

• Shortness of breath
• Wheezing
• Hives
• Chest tightness
• Low blood pressure
• Itching

Inhibitor Production

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

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 Altuviiio

Before you receive your first dose, inform your provider if you:

• Have or had any medical issues.
• Are allergic to this product, any product component, or any other medications.
• Are pregnant or planning to get pregnant. It is unknown if this medication harms your unborn baby. 
• Are breastfeeding. It is unknown if this medication is present in breast milk, and if it can harm the baby. 

Altuviiio Introduction and Uses

Altuviiio injection is a brand-name prescription product. It contains the active ingredient “recombinant clotting factor VIII”, also called the recombinant antihemophilic factor. Altuviiio belongs to a class of medications 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 because they have a deficiency of coagulation factor VIII. 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.

Altuviiio Mechanism of Action

Three components in Altuviiio work together to stop the bleeding. They are:

• Fc Fusion, which helps Factor VIII recirculate in the blood. 
• XTEN Technology, which helps prevent the early breakdown of Factor VIII. 
• vWF Fragments, which help Factor VIII stay longer in the blood.

Altuviiio’s half-life is three to four times greater than other Factor VIII products. This means the medication remains in the body for longer, enabling a once-weekly dosing schedule. 

Altuviio Dosage

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

The following strengths are available in the US: 

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

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

The dose and duration of treatment depend on:

• Body weight
• Severity of factor VIII deficiency
• Desired factor VIII level

Dosing for Routine Prophylaxis (Prevention)

For children and adults: 50 IU/kg of Altuviiio administered once weekly. 

Dosing for Control of Bleeding Episodes

• Minor and moderate bleeding: Single dose of 50 IU/kg. 
• Major bleeding: Single dose of 50 IU/kg. 

Dosing for Preventing Bleeding During Surgery

• Minor surgery: Single dose of 50 IU/kg. An additional dose of 30 or 50 IU/kg may be considered 2 to 3 days after surgery (post-operative dose).
• Major surgery: Single dose of 50 IU/kg. If needed, a healthcare provider may administer additional doses of 30 or 50 IU/kg every 2 to 3 days.

Altuviiio Side Effects

Headache and joint pain are the most common side effects. Inform your healthcare provider if other side effects occur. 

Altuviiio Proper Use

Your healthcare provider will teach you or your caregiver how to mix and administer Altuviiio when used for the first time. 

Important Things To Know Before Injecting Altuviiio

• Read all instructions carefully. If you have any questions, talk to your healthcare provider. 
• Before injecting, you should mix Altuviiio powder with liquid that comes in a prefilled syringe. 
• The solution is administered intravenously. 
• Don’t use Altuviiio if it has been damaged, the solution is cloudy, or if the syringe cap is not securely attached. 

Altuviiio Storage and Handling 

Before Preparing the Solution

• Store in the original package.
• 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.
• After you remove the product from the refrigerator, allow the vial and prefilled syringe to come to room temperature before injecting. 
• Never put the vial or prefilled syringe in hot water. 
• Once at room temperature, avoid returning the product to the refrigerator.
• Keep the product away from direct sunlight. 

After Preparing the Solution

• Avoid direct sun exposure. 
• Use the solution within 3 hours after mixing. 
• Don’t refrigerate after preparing the solution. 

Altuviiio Cost

Cost can vary depending on your insurance plan, location, and pharmacy. Contact your insurance provider to determine whether your plan covers this medication and whether prior authorization is required.

Sanofi Corporation, the manufacturer of Altuviiio, offers financial assistance through its HemAssist™ program. You can also enroll in the copay program and the free-trial program. 

Click here to talk about your options with one of our financial assistance specialists. 

Altuviiio vs. Hemlibra

Both medicines are used to help prevent bleeding in people with hemophilia A. But these medicines differ in their mechanism of action and route of administration. According to a 2024 study, Altuviiio may be superior to Hemlibra in preventing bleeding in certain patients with hemophilia A [1]. Your healthcare provider will help determine the most appropriate medication for your condition.