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These highlights do not include all the information needed to use CERDELGA® safely and effectively. See full prescribing information for CERDELGA. CERDELGA® (eliglustat) capsules, for oral useInitial U.S. Approval: 2014
Medication labelWhy this: Advisory · dailymed-prescription
CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test [see Dosage and Administration (2.1)]. Limitations of Use: Patients who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect [see Clinical Studies (14)]. A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined (indeterminate metabolizers) [see Clinical Studies (14)].
- generic_name
- eliglustat
- product_names
- eliglustat
- ndc
- 58468-0220, 58468-0220-1, 58468-0220-2
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en