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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 people with autoimmune disorders?
Tirzepatide has not been studied in people with significant and active autoimmune disorders. Eli Lilly and Company cannot provide treatment recommendations on the use of tirzepatide in people with these conditions.
See important safety information, including boxed warning, in the attached prescribing information.
Tirzepatide Use in Patients With Autoimmune Disorders
No information is available on the use of tirzepatide in patients with significant and active autoimmune abnormalities such as, but not limited to, lupus, multiple sclerosis, or rheumatoid arthritis. Participants were excluded from clinical trials if they were receiving, or likely to require systemic glucocorticoids during the course of the study.1-9
Clinical Considerations
Eli Lilly and Company cannot provide treatment recommendations on the use of tirzepatide in patients with a history of a significant and active autoimmune disorder. 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 practitioner should consider potential risks and benefits of treatment options and monitor appropriately.
Tirzepatide Studies in Psoriatic Arthritis and Plaque Psoriasis (TOGETHER-PsA and TOGETHER-PsO)
The efficacy and safety of ixekizumab and ixekizumab concomitantly administered with tirzepatide is being evaluated in two phase 3b studies in adult participants (≥18 years of age) with obesity or overweight and
- active psoriatic arthritis (TOGETHER-PsA), or
- moderate-to-severe plaque psoriasis (TOGETHER-PsO).10-12
There are no available safety data on the use of ixekizumab with concomitantly administered tirzepatide.12
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Rosenstock 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
2Frías 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
3Ludvik 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
4Del 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
5Dahl 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
6Jastreboff 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
7Garvey 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
8Wadden 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
9Aronne 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
10Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight (TOGETHER-PsA). ClinicalTrials.gov identifier: NCT06588296. Updated April 3, 2025. Accessed April 10, 2025. https://clinicaltrials.gov/study/NCT06588296
11Ixekizumab concomitantly administered with tirzepatide in adults with moderate-to-severe plaque psoriasis and obesity or overweight (TOGETHER-PsO). ClinicalTrials.gov identifier: NCT06588283. Updated February 27, 2025. Accessed April 10, 2025. https://clinicaltrials.gov/study/NCT06588283
12Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: March 12, 2025