If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
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.
Why is Zepbound® (tirzepatide) 7.5 and 12.5 mg doses not included as maintenance or therapeutic doses?
In the Zepbound studies, tirzepatide doses were escalated to 5 mg, 10 mg, or 15 mg SC once weekly during a 20-week titration period followed by the maintenance period. Lilly did not study Zepbound 7.5 and 12.5 mg as maintenance dosages.
See important safety information, including boxed warning, in the attached prescribing information.
Maintenance at 7.5 or 12.5 mg Doses
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 are 5, 10, or 15 mg injected subcutaneously once weekly.1
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
Additional Data at 7.5 and 12.5 mg Doses
The SURMOUNT program utilized a stepwise approach for dose escalation. All patients assigned to tirzepatide initiated treatment at 2.5 mg once weekly. The dose was increased every 4 weeks by 2.5 mg until patients reached their assigned maintenance dose.2
Eli Lilly and Company has not sponsored any studies evaluating the efficacy and safety of tirzepatide at maintenance doses of 7.5 mg or 12.5 mg.
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
Date of Last Review: November 21, 2024