Altuviiio FDA Approval History
Last updated by Judith Stewart, BPharm on March 1, 2023.
FDA Approved: Yes (First approved February 22, 2023)
Brand name: Altuviiio
Generic name: antihemophilic factor recombinant, Fc-VWF-XTEN fusion protein-ehtl
Previous name: efanesoctocog alfa
Dosage form: Lyophilized Powder for Injection
Company: Sanofi
Treatment for: Hemophilia A
Altuviiio [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNA-derived, factor VIII concentrate indicated for use in people with hemophilia A.
- Altuviiio is indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:
- routine prophylaxis to reduce the frequency of bleeding episodes
- on-demand treatment & control of bleeding episodes
- perioperative management of bleeding.
Limitation of Use: Altuviiio is not indicated for the treatment of von Willebrand disease.
- Hemophilia A is an inherited disorder in which a person’s blood does not clot properly due to a deficiency or insufficiency of a clotting protein called factor VIII. It can lead to uncontrolled and often spontaneous bleeding. Treatment involves replacing the missing clotting factor.
- Altuviiio is designed to deliver normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, and has been shown to significantly reduce bleeds compared to prior factor VIII prophylaxis.
- Altuviiio is administered via intravenous injection once weekly for routine prophylaxis, and on-demand for treatment and control of bleeding episodes and perioperative management.
- Warnings and precautions associated with Altuviiio include hypersensitivity reactions (including anaphylaxis) and formation of neutralizing antibodies (inhibitors) to factor VIII.
- Common adverse reactions include headache and arthralgia.
Development timeline for Altuviiio
See also
Altuviiio (antihemophilic factor recombinant, Fc-VWF-XTEN fusion protein-ehtl) Consumer information
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
