References
XTEND-ed is ongoing. Data cut: 22 February 2024.
*For minor and moderate bleeding episodes occurring within 2–3 days after a prophylactic dose, a lower dose of 30 IU/kg dose may be used. Additional doses of 30 or 50 IU/kg every 2–3 days may be considered. For major bleeding, additional doses of 30 or 50 IU/kg every 2–3 days can be considered;1
†For minor surgery, an additional dose of 30 or 50 IU/kg after 2–3 days may be considered. For major surgery, additional doses of 30 or 50 IU/kg every 2–3 days may be administered as clinically needed for perioperative management;1
‡Assessment of response to ALTUVOCT treatment of individual bleeding episodes based on the ISTH 4-point response scale; Investigators' or Surgeons' assessment of participant’s haemostatic response to ALTUVOCT treatment on the ISTH 4-point response for surgical procedures scale.
AE, adverse event; ISTH, International Society on Thrombosis and Haemostasis; PwHA, people living with haemophilia A; TEAE, treatment emergent adverse event.
- Sobi. ALTUVOCT SmPC, 2026