Cerezyme® (imiglucerase)

Cerezyme (imiglucerase) is covered for FDA‑approved Type 1 Gaucher disease and compendial off‑label use for Type 3 Gaucher disease in patients ≥2 years, but Type 3 use is not covered for neurological manifestations (only for impaired growth, hematologic, or visceral symptoms). Approval requires diagnostic confirmation (deficient β‑glucocerebrosidase activity or biallelic GBA pathogenic variants), prescription/consultation by a geneticist/endocrinologist/metabolic/lysosomal disorder specialist, documentation of age and clinical need, adherence to dosing limits (Type 1: 2.5 units/kg IV three times weekly up to 60 units/kg IV every two weeks; Type 3: ≤120 units/kg IV every two weeks), and is authorized for up to one year.

"Type 1 Gaucher disease: Cerezyme is indicated for the treatment of individuals with Type 1 Gaucher disease."

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