Soliris® (eculizumab)

Soliris (eculizumab) is authorized for FDA‑approved uses—PNH, aHUS (excluding Shiga toxin E. coli–related HUS), anti‑AChR antibody–positive gMG (adults), and anti‑AQP4 antibody–positive NMOSD (adults)—and must be given IV. Approval requires specialist prescribing/consultation (hematologist for PNH, nephrologist for aHUS, neurologist for gMG/NMOSD), diagnostic confirmation (flow cytometry for PNH; antibody serology for gMG/NMOSD), age/prior‑therapy and severity criteria for gMG (≥18, MG‑ADL ≥6, prior pyridostigmine and two immunosuppressants unless contraindicated), documented benefit for renewals, and specified approval durations (PNH initial 6 mo/renewal 12 mo; aHUS 12 mo).

"aHUS prescribing documentation: "Soliris is prescribed by or in consultation with a nephrologist."

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