Altuviiio (efanesoctocog alfa)

A once-weekly factor VIII infusion into a vein for adults and children with hemophilia A. It replaces the missing clotting protein directly, and the FDA label says it lasts 3 to 4 times longer than other factor VIII products, keeping factor VIII above 40% of normal for about 4 days of each week in adults.

People with hemophilia A are missing factor VIII, a protein the blood needs to form a clot. Altuviiio is a lab-made version of factor VIII given into a vein, so it does the missing protein's job directly. Ordinary factor VIII is cleared quickly partly because it rides on another blood protein, von Willebrand factor. Altuviiio carries its own piece of von Willebrand factor plus two other add-ons (an antibody Fc piece and XTEN chains), which frees it from that limit. According to the FDA label, its half-life is about 48 hours in adults, 3 to 4 times longer than other factor VIII products.

In the trials, the most common side effects were headache (15%) and joint pain (13%) across all ages; in children under 12, fever was the most common (12%). There is no boxed warning. The label warns about allergic reactions, including anaphylaxis, which have been reported since approval, and about inhibitors (antibodies that stop factor VIII from working); no inhibitors were found in the trials, but they have been reported since. Some lab tests read Altuviiio's factor VIII level about 2.5 times too high, so the label recommends a specific test type. Blood clots occurred in 1% of people (3 of 261) in the long-term extension study, all with existing risk factors.

Infused into a vein, 50 IU per kg of body weight once a week for prevention. The same 50 IU/kg dose is used to treat a bleed or to cover surgery. Many people learn to infuse at home after training from their hemophilia treatment center. Unopened vials are kept in the refrigerator, or at room temperature up to 86°F for a single period of up to 6 months.

Yes, Efanesoctocog alfa (Altuviiio) is FDA approved (2023) for the treatment of Hemophilia A.

No trial has compared them, so neither can be called better. They work differently. Altuviiio replaces the missing factor VIII and is infused into a vein once a week; Hemlibra is an antibody that copies factor VIII's job and is injected under the skin weekly, every 2 weeks or every 4 weeks. In its main trial, people on weekly Altuviiio averaged 0.7 treated bleeds a year. In HAVEN 3, people without inhibitors on weekly Hemlibra averaged 1.5. The trials enrolled different people and measured against different comparisons, so the numbers are not a head-to-head result. Hemlibra is approved for people with factor VIII inhibitors; Altuviiio's trials enrolled only people without them.

Once a week for prevention, at 50 IU per kg of body weight, infused into a vein. Many people learn to infuse at home. The same dose is used to treat a bleed or before surgery.

Inhibitors are antibodies that block factor VIII, and Altuviiio is factor VIII, so they can stop it from working. Its trials enrolled only people without inhibitors. People with inhibitors usually use Hemlibra or another non-factor option such as Hympavzi, Alhemo or Qfitlia; ask your hemophilia treatment center which fits you.

Both are Sanofi factor VIII products. Eloctate is an earlier extended half-life factor VIII usually given every 3 to 5 days. Altuviiio adds a piece of von Willebrand factor and XTEN chains, which the label says gives it a half-life 3 to 4 times longer than other factor VIII products, allowing once-weekly dosing.

Yes. Sanofi HemAssist offers copay help for people with commercial insurance (as little as $0), a Free Trial with the first 30-day supply, and a Patient Assistance Program for eligible people who are uninsured or underinsured. Call 1-833-723-5463, Monday to Friday, 8 AM to 7 PM ET.