Efgartigimod alfa products (Vyvgart-Vyvgart Hytrulo)

Covers Vyvgart and Vyvgart Hytrulo for FDA‑approved use in adults with anti‑acetylcholine receptor (anti‑AChR) antibody‑positive generalized myasthenia gravis; non‑FDA indications and pediatric use are excluded. Key requirements: age ≥18, documented anti‑AChR positivity, MGFA class II–IV with MG‑ADL ≥5 and unresolved gMG symptoms, prior/current pyridostigmine unless failed/contraindicated/intolerant, prescribed by or in consultation with a neurologist, dosing once weekly ×4 per cycle (IV 10 mg/kg or SC 1008 mg with hyaluronidase) with subsequent cycles only after clinical reassessment and not sooner than 50 days, initial approval 6 months and renewals 12 months with required documentation (labs, MGFA/MG‑ADL, weight, treatment dates).

"FDA-approved indication: Treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive."