Idursulfase (Elaprase)

Idursulfase (Elaprase) is covered only for the FDA‑approved indication of mucopolysaccharidosis type II (Hunter syndrome) when diagnosis is confirmed by iduronate sulfatase enzyme assay or genetic testing, with coverage authorized for 12 months; off‑label uses are not supported. Use is subject to safety limitations — risk of life‑threatening or delayed anaphylaxis (up to 24 hours), higher hypersensitivity/antibody‑related risk in young patients with complete deletions/large rearrangements/nonsense/frameshift/splice mutations or those positive for anti‑idursulfase IgG, and caution (or deferral) in patients with compromised respiratory function or acute febrile/respiratory illness.

"Elaprase® (idursulfase) is indicated for the treatment of individuals with mucopolysaccharidosis type II (Hunter syndrome)."

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