Qfitlia (fitusiran) — Medica

Hemophilia A with Factor VIII inhibitors

Initial criteria

age ≥ 12 years
using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Factor VIII inhibitor titer testing performed within past 30 days and positive test for Factor VIII inhibitors ≥ 0.6 Bethesda units/mL
prescriber will discontinue prophylactic use of bypassing agents no later than 7 days following the initial Qfitlia dose (use for breakthrough bleeding is permitted)
not undergoing immune tolerance induction therapy
prescribed by or in consultation with a hemophilia specialist

using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
prophylactic use of bypassing agents will not occur while receiving Qfitlia (use for breakthrough bleeding is permitted)
not undergoing immune tolerance induction therapy
prescribed by or in consultation with a hemophilia specialist
beneficial response to therapy (e.g., reduction in bleeding events or severity, fewer bleeds requiring treatment, and/or fewer spontaneous bleeds)

1 year