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Mounjaro ® (tirzepatide) injection
2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can Mounjaro™ (tirzepatide) be used in children?
Tirzepatide’s safety and efficacy have not been established in patients under 18 years. SURPASS-PEDS is evaluating tirzepatide in patients 10 to below 18 years old with type 2 diabetes inadequately controlled with metformin, basal insulin, or both.
See important safety information, including boxed warning, in the attached prescribing information.
Approved Indication
Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) for once-weekly, subcutaneous administration.1
Use in Children
The safety and efficacy of tirzepatide have not been established in pediatric patients and tirzepatide is not approved for use in patients younger than 18 years.
SURPASS-PEDS is an ongoing, phase 3, randomized, double-blind study with an open-label extension, evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of once-weekly tirzepatide compared with placebo in pediatric and adolescent patients with T2D. The study duration is approximately 60 weeks.2
The primary outcome is change from baseline in glycated hemoglobin (HbA1c) at week 30. Key inclusion criteria are
- participants aged 10 to below 18 years at screening
- T2D
- treatment with diet and exercise and metformin and/or basal insulin at stable doses for at least 90 days
- HbA1c >6.5% to ≤11% at screening, and
- body weight ≥110 pounds (50 kg) and body mass index >85th percentile.2
Enclosed Prescribing Information
References
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
2A study to evaluate tirzepatide (LY3298176) in pediatric and adolescent participants with type 2 diabetes mellitus inadequately controlled with metformin or basal insulin or both (SURPASS-PEDS). ClinicalTrials.gov identifier: NCT05260021. Updated February 23, 2023. Accessed March 1, 2023. https://clinicaltrials.gov/ct2/show/NCT05260021
Date of Last Review: February 14, 2023