ALTUVIIIO™ [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion

Sanofi

ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNA-derived, Factor VIII concentrate 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 (1)

Limitation of Use:

ALTUVIIIO is not indicated for the treatment of von Willebrand disease. (1)

Prior to reconstitution

• Store ALTUVIIIO in the original package to protect the ALTUVIIIO vials from light.
• Store ALTUVIIIO in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze to avoid damage to the prefilled diluent syringe.
• ALTUVIIIO may be stored at room temperature, not to exceed 30°C (86°F), for a single period of up to 6 months, within the expiration date printed on the label.
• If stored at room temperature, record the date that ALTUVIIIO is removed from refrigeration on the carton in the area provided. After storage at room temperature, do not return the product to the refrigerator.
• Do not use beyond the expiration date printed on the vial or 6 months after the date that was written on the carton, whichever is earlier.

After Reconstitution

• The reconstituted product may be stored at room temperature, not to exceed 30°C (86°F), for up to 3 hours. Protect from direct sunlight. After reconstitution, if the product is not used within 3 hours, it must be discarded.
• Do not use ALTUVIIIO if the reconstituted solution is cloudy or has particulate matter.
• Discard any unused ALTUVIIIO.