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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 patients with gastroparesis?
Tirzepatide has not been studied in people with severe gastroparesis and is therefore not recommended in these patients.
See important safety information, including boxed warning, in the attached prescribing information.
Gastroparesis
Gastroparesis refers to a collection of disorders of varied etiologies in which gastric emptying is impaired or delayed, without evidence of obstruction.1
Tirzepatide delays gastric emptying. The delay is largest after the first dose and this effect diminishes over time.2
The use of tirzepatide has been associated with gastrointestinal adverse reactions, sometimes severe.2
In the tirzepatide phase 3 program for type 2 diabetes, including 5119 participants randomized to any dose of tirzepatide, there was 1 report of the Medical Dictionary for Regulatory Activities (MedDRA) preferred term of diabetic gastroparesis in the tirzepatide 5 mg arm. This was reported as mild in severity and the patient did not discontinue treatment.3
Tirzepatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.2
Tirzepatide has not been studied in people with severe gastrointestinal disease and patients with significant gastric emptying abnormality, such as severe gastroparesis, because they were excluded from the SURPASS and SURMOUNT clinical trials if they had a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction).3
Patient safety is Eli Lilly and Company’s top priority, and we actively engage in monitoring, evaluating, and reporting safety information for all our medicines.
Enclosed Prescribing Information
Reference
1Camilleri M, Parkman HP, Shafi MA, et al. American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013;108(1):18-38. https://doi.org/10.1038%2Fajg.2012.373
2Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: November 06, 2023