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Trulicity ® (dulaglutide) injection
0.75 mg/0.5 mL, 1.5 mg/0.5 mL, 3mg/0.5mL, 4.5mg/0.5mL
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.
Can multiple Trulicity® (dulaglutide) injections be used to make a larger dose?
Lilly does not recommend using multiple dulaglutide injections to make a larger dose. Multiple injections of lower doses were studied in a phase 2 study as part of the development of higher doses but combining multiple dose injections is not recommended.
See important safety information, including boxed warning, in the attached prescribing information.
Multiple Dulaglutide Injections
Administering Multiple Injections
Administering multiple injections of dulaglutide has not been tested in a phase 3 clinical study, so there is limited evidence to support the efficacy and safety of administering multiple injections to create a higher dose. Using multiple dulaglutide injections is not captured in the United States Prescribing Information; therefore, Eli Lilly and Company does not recommend using multiple lower dose injections.1
Approved Dosage Strengths
Dulaglutide is a clear, colorless solution available as a
- 0.75 mg/0.5 mL solution in a single-dose pen
- 1.5 mg/0.5 mL solution in a single-dose pen
- 3 mg/0.5 mL solution in a single-dose pen, and
- 4.5 mg/0.5 mL solution in a single-dose pen.1
Approved Dosage Regimen
Adult Dosage
The recommended starting dosage of dulaglutide is 0.75 mg injected subcutaneously once weekly.2
Increase the dosage to 1.5 mg once weekly for additional glycemic control.1
If additional glycemic control is needed, increase the dosage in 1.5 mg increments after at least 4 weeks on the current dosage.1
The maximum recommended dosage is 4.5 mg injected subcutaneously once weekly.1
Pediatric Dosage (Patients 10 Years of Age and Older)
The safety and effectiveness of dulaglutide have not been established in pediatric patients less than 10 years of age.1
The recommended starting dosage of dulaglutide is 0.75 mg injected subcutaneously once weekly.1
If additional glycemic control is needed, increase the dosage to the maximum recommended dosage of 1.5 mg once weekly after at least 4 weeks on the 0.75 mg dosage.1
Combining Injections in a Phase 2 Study
The phase 2 study, GBGJ, compared dulaglutide 1.5 mg, 3.0 mg, and 4.5 mg with placebo. Patients randomized to dulaglutide 3.0 mg received two 1.5 mg doses, and patients randomized to dulaglutide 4.5 mg dose received three 1.5 mg doses.2,3
Efficacy and safety results of this phase 2 trial led to further development and completeness of the phase 3 study, AWARD-11, which was the basis for the approval of the higher doses.2
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Frias JP, Wynne AG, Matyjaszek-Matuszek B, et al. Efficacy and safety of an expanded dulaglutide dose range: a phase 2, placebo-controlled trial in patients with type 2 diabetes using metformin. Diabetes Obes Metab. 2019;21(9):2048-2057. https://doi.org/10.1111/dom.13764
Date of Last Review: January 14, 2022