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These highlights do not include all the information needed to use AVLAYAH™ safely and effectively. See full prescribing information for AVLAYAH. AVLAYAH (tividenofusp alfa-eknm) for injection, for intravenous useInitial U.S. Approval: 2026
Medication labelWhy this: Advisory · dailymed-prescription
AVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. This indication is approved under accelerated approval based on the reduction of cerebrospinal fluid heparan sulfate [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use AVLAYAH is not recommended for use in combination with other enzyme replacement therapies for the treatment of Hunter syndrome.
- generic_name
- tividenofusp alfa-eknm
- product_names
- tividenofusp alfa-eknm
- ndc
- 84976-001, 84976-001-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en