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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.
What is the recommended Mounjaro® (tirzepatide) dose in pediatric patients with T2D?
In pediatric patients with T2D, tirzepatide should be initiated at 2.5 mg subcutaneously once weekly and increased in 2.5 mg increments every 4 weeks until target dose is achieved, up to a maximum dose of 10 mg.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
Indication and Dose Recommendations From Prescribing Information
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 and pediatric patients 10 years of age and older with type 2 diabetes (T2D) for once-weekly, subcutaneous administration.1
The safety and effectiveness of tirzepatide have not been established in pediatric patients less than 10 years of age.1
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Dose Escalation and Maximum Dose of Tirzepatide for Pediatric Patients With T2D
The recommended dosing of tirzepatide is as follows:
- start with 2.5 mg injected subcutaneously once weekly
- after 4 weeks, increase to 5 mg injected subcutaneously once weekly, and
- if additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose, up to maximum dose of 10 mg subcutaneously once weekly. 1
The dose escalation is recommended to reduce the risk of gastrointestinal adverse reactions.1
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Administration of Tirzepatide
Tirzepatide is administered once weekly at any time of day, with or without meals. 1
Tirzepatide is injected subcutaneously
- in the abdomen or thigh, or
- by another person in the back of the upper arm.1
Injection sites should be rotated with each dose. 1
The day of weekly administration can be changed, if necessary, as long as the time between tirzepatide doses is 3 days (72 hours) or more.1
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Missed Dose
If a dose is missed, when the next dose is administered depends on the following schedule (Instructions for a Missed Dose of Tirzepatide).1
If a dose of tirzepatide is missed and it is… |
Then… |
And... |
4 days (96 hours) or less after the missed dose |
it should be administered as soon as possible |
patients can resume their regular once-weekly dosing schedule. |
more than 4 day (96 hours) after the missed dose |
the missed dose should be skipped |
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Maximum Dose Rationale Based on Pediatric Pharmacokinetics
SURPASS-PEDS was a phase 3, randomized, double-blind, parallel arm, placebo-controlled study with an open-label extension. The study evaluated the safety and efficacy of once-weekly tirzepatide (5 and 10 mg) compared with placebo in pediatric and adolescent patients (10 to <18-year-olds) with T2D inadequately controlled with metformin and/or basal insulin.2
A maximum dose of 10 mg was selected for SURPASS-PEDS based on pharmacokinetic and pharmacodynamic exposure–response modelling, which predicted that this dose in a pediatric participant with a minimum body weight of 50 kg would provide adult exposure levels associated with clinically significant glycemic efficacy.2
As part of the SURPASS-PEDS trial, a population pharmacokinetic analysis was conducted for tirzepatide 5 mg and 10 mg using data from 93 of the pediatric participants. The tirzepatide exposure in pediatric patients was comparable to that observed in adult patients.1,2
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Use of Higher Than 10 mg Maximum Dose in Pediatric Patients
No information is available regarding the use of any tirzepatide dose above the maximum recommended dose of 10 mg once weekly in pediatric patients 10 years of age and older for the treatment of T2D.
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Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2Hannon TS, Chao LC, Barrientos-Pérez M, et al. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2025;406(10511):1484-1496. https://doi.org/10.1016/S0140-6736(25)01774-X
Date of Last Review: November 10, 2025