Agalsidase Beta (Fabrazyme)

Fabrazyme (agalsidase beta) is covered only for the FDA‑approved indication of Fabry disease and off‑label uses are not supported. Approval requires documentation of alpha‑galactosidase A deficiency by enzyme assay or confirmatory genetic testing, adherence to applicable coverage/safety criteria (approvals for 12 months), immediate discontinuation for severe allergic/anaphylactic reactions, and recommended antipyretic/antihistamine pretreatment plus infusion-rate adjustments for infusion reactions.

"Fabrazyme (agalsidase beta) is indicated for the treatment of individuals with Fabry disease."

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