Ultomiris® (ravulizumab-cwvz) Intravenous Injection

Ultomiris (ravulizumab‑cwvz) is authorized for FDA‑approved uses—PNH and aHUS in patients ≥1 month old, adult anti‑AChR antibody–positive gMG, and adult AQP4‑antibody–positive NMOSD—and excludes Shiga toxin E. coli–related HUS. Approval requires indication‑specific documentation (PNH: flow cytometry showing GPI‑anchored protein deficiency on ≥2 lineages and hematology consult; aHUS: exclusion of Shiga‑toxin E. coli HUS and nephrology consult; gMG: anti‑AChR positivity, age ≥18, MGFA II–IV, MG‑ADL ≥6, prior pyridostigmine and ≥2 immunosuppressants unless contraindicated, neurology consult; NMOSD: AQP4 antibody positive and neurology consult), weight‑based dosing, specified initial/renewal approval durations (PNH initial 6 months/renewal 12; aHUS 12; gMG initial 6/renewal 12; NMOSD 12), and evidence of continued benefit for reauthorization.

"Paroxysmal Nocturnal Hemoglobinuria (PNH) — indicated for the treatment of adult and pediatric patients one month of age and older with PNH."