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Zepbound ® (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 dose escalation schedule for Zepbound® (tirzepatide)?
Tirzepatide should be initiated at 2.5 mg injected subcutaneously once weekly and increased to 5 mg after 4 weeks. The dose may be increased in 2.5 mg increments after at least 4 weeks on the current dose, up to a maximum dose of 15 mg.
See important safety information, including boxed warning, in the attached prescribing information.
Dose Escalation
Approved Dosing
The recommended starting dosage of tirzepatide is 2.5 mg injected subcutaneously once weekly. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions. The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage.1
After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly.1
The dosage may be increased in 2.5 mg increments, after at least 4 weeks on the current dose.1
The recommended maintenance dosages of tirzepatide in adults for weight reduction are 5, 10, or 15 mg injected subcutaneously once weekly.1
The recommended maintenance dosages of tirzepatide in adults for obstructive sleep apnea are 10 or 15 mg injected subcutaneously once weekly.
Consider treatment response and tolerability when selecting the maintenance dosage. If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage.1
The maximum dosage of tirzepatide is 15 mg injected subcutaneously once weekly.1
Administer in combination with a reduced-calorie diet and increase physical activity.1
Administer tirzepatide
- once weekly
- any time of day, and
- with or without food.1
Clinical Studies
The global phase 3 SURMOUNT clinical program for weight management evaluated tirzepatide 5, 10, 15 mg, and maximum tolerated dosages for safety and efficacy. These doses and associated dose-escalation schemes (Dose Escalation Schedule for Tirzepatide in Phase 3 Clinical Studies) were based on the assessment of safety, efficacy (weight loss), and GI tolerability data in phase 1 and 2 studies in patients with T2DM, followed by exposure-response modeling of the data that predicted weight loss in patients with overweight or obesity.2
The SURMOUNT-OSA master protocol described two 52-week, phase 3, double-blind, randomized studies of tirzepatide maximum tolerated dose (MTD) (10 or 15 mg) once weekly compared with placebo in 469 adults with moderate to severe OSA and obesity. Both of these OSA studies followed the same dosage escalation scheme that was used in the clinical development program for weight management.3
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Zepbound [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
2le Roux CW, Zhang S, Aronne LJ, et al. Tirzepatide for the treatment of obesity: rationale and design of the SURMOUNT clinical development program. Obesity (Silver Spring). 2023;31(1):96-110. https://doi.org/10.1002/oby.23612
3Malhotra A, Grunstein RR, Fietze I, et al; SURMOUNT-OSA Investigators. Tirzepatide for the treatment of obstructive sleep apnea and obesity. N Engl J Med. 2024;391(13):1193-1205. https://doi.org/10.1056/NEJMoa2404881
4Conterno E, Yuffa I, Woodward B. Eli Lilly and Company diabetes 2019 business update. Eli Lilly and Company. Published June 10, 2019. Accessed January 22, 2025. https://investor.lilly.com/static-files/a5dbe9fa-f45f-41ef-bc16-bc12be6dd606
Date of Last Review: October 21, 2024