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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.
Have hypersensitivity reactions been reported with Trulicity® (dulaglutide)?
Serious hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported with dulaglutide.
See important safety information, including boxed warning, in the attached prescribing information.
Dulaglutide and Hypersensitivity
Dulaglutide is contraindicated in patients with a serious hypersensitivity reaction to dulaglutide or to any of the product components.1
Serious hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported with dulaglutide.1
If a hypersensitivity reaction occurs, discontinue dulaglutide, treat promptly per standard of care, and monitor until signs and symptoms resolve.1
Do not use in patients with a previous hypersensitivity reaction to dulaglutide.1
Anaphylaxis and angioedema have been reported with other glucagon-like peptide-1 receptor agonists (GLP-1 RAs).1
Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 RA because it is unknown whether such patients will be predisposed to anaphylaxis with dulaglutide.1
Clinical Study Experience
Systemic hypersensitivity adverse reactions, some of which were severe, occurred in 0.5% of patients on dulaglutide in clinical studies and included
- severe urticaria
- systemic rash
- facial edema, and
- lip swelling.1
Postmarketing (Spontaneous) Adverse Event Reports
Postmarketing data do not necessarily represent the rate of occurrence of an adverse event in a treated population, but they represent a reporting rate of a particular adverse event to the company. Spontaneous reporting of adverse events can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an adverse event.2
Spontaneous reporting has limited use due to
- lack of control population
- under-reporting or reporting bias, and
- missing or incomplete information regarding patient's medical history or concomitant medications.2
The Eli Lilly and Company (Lilly) spontaneous adverse event database may also include reports of adverse events for products that may be available from Lilly and from other manufacturers. Although verification of product manufacturer is sought, this verification is not always obtainable. The default for these cases is to include them in the database.2
There have been reports of anaphylactic reactions and angioedema during postapproval use of dulaglutide.1
Anaphylactic Reaction
Through September 18, 2021, the Medical Dictionary for Regulatory Activities (MedDRA) preferred term of anaphylactic reaction has been Very Rarely Reported in the Lilly spontaneous adverse event database, based on the estimated exposure of 9,987,000 patients. Very Rarely Reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.2
Angioedema
Through September 18, 2021, the MedDRA preferred term of angioedema has been Very Rarely Reported in the Lilly spontaneous adverse event database, based on the estimated exposure of 9,987,000 patients. Very Rarely Reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.2
Enclosed Prescribing Information
References
1Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: June 14, 2022