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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 people with gallbladder disease or prior gallbladder removal take Mounjaro® (tirzepatide)?
Lilly cannot provide treatment recommendations on the use of tirzepatide in people with a history of gallbladder disease or removal. These participants were not excluded from tirzepatide trials, but no subgroup analysis was completed in this population.
See important safety information, including boxed warning, in the attached prescribing information.
Tirzepatide Use in Patients With Gallbladder Disease or Prior Gallbladder Removal
The use of tirzepatide in people with gallbladder disease or prior gallbladder removal is not listed as a contraindication.1
Participants with gallbladder disease or prior gallbladder removal were not explicitly excluded from the tirzepatide clinical trial programs in type 2 diabetes or chronic weight management.2-10
Eli Lilly and Company has not sponsored a subgroup analysis in participants with a preexisting condition of gallbladder disease or prior gallbladder removal in the tirzepatide type 2 diabetes and chronic weight management clinical studies.
Clinical Considerations
Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing.1
In 2 studies comparing tirzepatide with placebo in adults with type 2 diabetes (SURPASS-1 and SURPASS-5), acute gallbladder disease (cholelithiasis, biliary colic, and cholecystectomy) was reported by 0.6% of tirzepatide-treated patients and 0% of placebo-treated patients.1
If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.1
Eli Lilly and Company cannot provide treatment recommendations on the use of tirzepatide in people who have a history of gallbladder disease or prior gallbladder removal. In formulating an assessment and approach, the health care practitioner may consider
- the information provided
- the patient’s prior medical history and concomitant medications, and
- other individual factors.
The health care professional should consider potential risks and benefits of tirzepatide use in these patients
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
2Rosenstock J, Wysham C, Frías JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. https://doi.org/10.1016/S0140-6736%2821%2901324-6
3Frías JP, Davies MJ, Rosenstock J, et al; SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503-515. https://doi.org/10.1056/NEJMoa2107519
4Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598. https://doi.org/10.1016/S0140-6736(21)01443-4
5Del Prato S, Kahn SE, Pavo I, et al; SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824. https://doi.org/10.1016/S0140-6736(21)02188-7
6Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. https://doi.org/10.1001/jama.2022.0078
7Jastreboff AM, Aronne LJ, Ahmad NN, et al; SURMOUNT-1 Investigators. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205-216. https://doi.org/10.1056/NEJMoa2206038
8Garvey WT, Frias JP, Jastreboff AM, et al; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023;402(10402):613-626. https://doi.org/10.1016/S0140-6736(23)01200-X
9Wadden TA, Chao AM, Machineni S, et al. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023;29(11):2909-2918. https://doi.org/10.1038/s41591-023-02597-w
10Aronne LJ, Sattar N, Horn DB, et al; SURMOUNT-4 Investigators. Continued treatment with tirzepatide for maintenance of weight reduction in adults with obesity: the SURMOUNT-4 randomized clinical trial. JAMA. 2024;331(1):38-48. https://doi.org/10.1001/jama.2023.24945
Date of Last Review: September 24, 2024