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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 formulation of Zepbound® (tirzepatide) the same in pens and vials?
The tirzepatide pens and vials contain the identical active ingredient, tirzepatide. Single-dose presentations do not contain preservatives.
See important safety information, including boxed warning, in the attached prescribing information.
Formulation of Approved Zepbound Presentations
Zepbound (tirzepatide) is approved by the Food and Drug Administration (FDA) in a
- single-dose pen
- multiple-dose pen
- single-dose vial, and
- multiple-dose vial.1
The pens and the vials have the identical active ingredient, tirzepatide, and are designed to deliver the same doses.1
Regardless of presentation, tirzepatide is administered subcutaneously once weekly, and the dosing regimen and administration sites (abdomen, thigh or back of upper arm) remain the same.1
The FDA has approved the Zepbound KwikPen and multiple dose vial.1
Attributes of the Tirzepatide Single-Dose Versus Multiple-Dose Presentations
The tirzepatide multidose presentations and the tirzepatide single-dose presentations have the identical active ingredient, tirzepatide, and are designed to deliver the same doses as the single-dose pen that that was tested in the SURMOUNT clinical trial program in adults with obesity or overweight or moderate-to-severe obstructive sleep apnea and obesity.1-6
Based on the results of bioequivalence studies, the efficacy and safety of tirzepatide administered between the autoinjector and other presentations can be expected to be comparable.
This includes the same excipients, excipient concentrations, and drug substance concentration.7
The single-dose vial and single-dose pen
- contain 1 fixed dose
- have a dosing volume of 0.5 mL per dose
- are for single use only, and
- do not contain preservatives.1
Differences between the single-dose presentations and multi-dose presentations include
- the dosing volume and
- the addition of the preservatives, phenol and benzyl alcohol, and the tonicity agent, glycerin as summarized in Comparison of Tirzepatide Formulation Ingredients.7
|
Tirzepatide Single-dose Pen or Vial (Nonpreserved Formulation) |
Tirzepatide Multi-dose Pen or Vial |
Ingredienta |
Quantity (per 0.5 mL) |
Quantity (per 0.6 mL) |
Tirzepatide |
2.5 mg/5 mg/7.5 mg/10 mg/ |
2.5 mg/5 mg/7.5 mg/10 mg/ |
Dibasic sodium phosphate heptahydrate |
0.7 mg |
0.8 mg |
Sodium chloride |
4.1 mg |
1.05 mg |
Hydrochloric acid solution |
as needed |
as needed |
Sodium hydroxide solution |
as needed |
as needed |
Water for injection |
as needed to 0.5 mL |
as needed to 0.6 mL |
Phenol |
NA |
1.08 mg |
Benzyl alcohol |
NA |
5.4 mg |
Glycerin |
NA |
4.8 mg |
Abbreviation: NA = not applicable.
aOnly the KwikPen contains preservatives (benzyl alcohol, phenol) and glycerin for tonicity.
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; 2026.
2Jastreboff 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
3Garvey 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
4Wadden 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
5Aronne 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
6Malhotra 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
7Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: January 20, 2025