Rystiggo® (rozanolixizumab-noli)

Rystiggo (rozanolixizumab‑noli) is covered for adults (≥18) with anti‑AChR or anti‑MuSK antibody‑positive generalized myasthenia gravis and is excluded for antibody‑negative patients, ocular‑only disease (MG‑ADL <3 for non‑ocular symptoms), and those under 18. Approval requires MGFA class II–IV, MG‑ADL ≥3 for non‑ocular symptoms, prior/current pyridostigmine unless intolerant, prescription by or in consultation with a neurologist, weight‑based once‑weekly dosing for 6 weeks per cycle (initial approval 6 months, renewals 12 months) with documentation of benefit and no subsequent cycle started sooner than 63 days from the prior cycle start.

"Approval durations: Initial approval duration 6 months; renewal approval duration 12 months."

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