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These highlights do not include all the information needed to use TZIELD safely and effectively. See full prescribing information for TZIELD. TZIELD® (teplizumab-mzwv) injection, for intravenous use Initial U.S. Approval: 2022
Medication labelWhy this: Advisory · dailymed-prescription
TZIELD is indicated to [see Dosage and Administration (2.1)]: Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced C-peptide decline [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: There is limited evidence of safety and effectiveness in patients aged 45 years and older with Stage 2 T1D. TZIELD is not effective as a disease modifying therapy in non-autoimmune dysglycemic conditions.
- generic_name
- teplizumab-mzwv
- product_names
- teplizumab-mzwv
- ndc
- 73650-316, 73650-316-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en