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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.
Is the efficacy of the Zepbound® (tirzepatide) single-dose vial presentation the same as the single-dose pen?
Both the single-dose vial and the single-dose pen are FDA-approved. The efficacy of tirzepatide was established in trials using the single-dose pen. Tirzepatide provided in a single-dose vial and a single-dose pen has the same drug formulation.
See important safety information, including boxed warning, in the attached prescribing information.
Efficacy of Tirzepatide Vial Versus Single-Dose Pen
In the SURMOUNT-1 and -2 phase 3 studies in adults with obesity or overweight, tirzepatide was administered through subcutaneous injection using a single-dose pen.1,2
Both the single-dose vial and the single-dose pen are FDA-approved.3
The efficacy of tirzepatide was established in trials using the single-dose pen. The primary difference is the delivery mechanism. Both options are designed to meet different needs and preferences of patients while maintaining the high standards of safety and effectiveness that Eli Lilly and Company (Lilly) is committed to.4
Tirzepatide provided in a single-dose vial and single-dose pen have the same drug formulation.3
This includes the same excipients, excipient concentrations, and drug substance concentration.3
Dose strengths, injection volume, and route of administration are also the same.3
Both the tirzepatide single-dose vial and single-dose pen are for single use and do not contain preservatives.3
Tirzepatide provided in a single-dose vial and a single-dose pen also has the same analytical attributes, including specification tests and acceptance criteria.4
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Jastreboff 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
2Garvey 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
3Zepbound [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Zepbound [medication guide]. Indianapolis, IN: Eli Lilly and Company; 2024.
6Zepbound Single-Dose Vial [instructions for use]. Indianapolis, IN: Eli Lilly and Company; 2024.
Date of Last Review: June 07, 2024