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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.
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. Eli Lilly and Company 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
Zepbound is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide‑1 (GLP‑1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of
- 30 kg/m2 or greater (obesity) or
- 27 kg/m2 or greater (overweight) with at least 1 weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes [T2D], obstructive sleep apnea, or cardiovascular disease).1
Approved Dosing
The recommended starting dose of tirzepatide is 2.5 mg injected subcutaneously once weekly. The 2.5 mg dosage is for treatment initiation and is not intended for chronic weight management.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 mg, 10 mg, 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
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; 2023.
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: March 01, 2024