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These highlights do not include all the information needed to use ZELVYSIA safely and effectively. See full prescribing information for ZELVYSIA. ZELVYSIA TM (sapropterin dihydrochloride) powder, for oral solution Initial U.S. Approval: 2007
Medication labelWhy this: Advisory · dailymed-prescription
Zelvysia is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Zelvysia is to be used in conjunction with a Phe-restricted diet.
- generic_name
- sapropterin dihydrochloride
- product_names
- SAPROPTERIN DIHYDROCHLORIDE, sapropterin dihydrochloride
- ndc
- 73289-0070, 73289-0070-1, 73289-0070-2, 73289-0071, 73289-0071-1, 73289-0071-2
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en