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.
Are there any differences in injection site reactions with Zepbound® (tirzepatide) administered from a vial versus the single-dose pen?
There are no data available on injection site reactions with tirzepatide administered from a single-dose vial. Tirzepatide from the single dose vial and single-dose pen have the same drug formulation and analytical attributes.
See important safety information, including boxed warning, in the attached prescribing information.
Injection Site Reactions With 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
In SURMOUNT-1 and -2, injection site reactions were reported in
- 6% of participants receiving tirzepatide 5 mg,
- 8% of participants receiving tirzepatide 10 mg,
- 8% of participants receiving tirzepatide 15 mg, and
- 2% of participants receiving placebo.3
Injection site reactions included multiple related adverse event terms, such as injection site bruising, injection site erythema, injection site pruritus, injection site pain, injection site rash, injection site reaction.3
There are no data available on injection site reactions with tirzepatide administered from a single-dose vial.
Tirzepatide provided in a single-dose vial and the 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.
Date of Last Review: June 07, 2024