Trulicity ® (dulaglutide) injection

0.75 mg/0.5 mL, 1.5 mg/0.5 mL

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.

TRULICITY® (dulaglutide): Hypersensitivity Including Anaphylactic Reactions and Angioedema

Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with Trulicity (dulaglutide).

Dulaglutide - Use with Metformin in Patients with Type 2 Diabetes

Trulicity® (dulaglutide) is contraindicated in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components (Trulicity Package Insert, 2017).

Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported in patients treated with dulaglutide and other glucagon-like peptide-1 receptor agonists. Use caution in a patient with a history of angioedema or anaphylaxis with another glucagon-like peptide-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with dulaglutide (Trulicity Package Insert, 2017).

If a hypersensitivity reaction occurs, discontinue dulaglutide, treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous hypersensitivity reaction to dulaglutide (Trulicity Package Insert, 2017).

Clinical Study Experience

Systemic hypersensitivity adverse reactions, that were sometimes severe and included severe urticaria, systemic rash, facial edema, and lip swelling, occurred in 0.5% of patients who received dulaglutide in 4 phase 2 and 5 phase 3 studies (Trulicity Package Insert, 2017).

Postmarketing Experience

There have been reports of anaphylactic reactions and angioedema during post-approval use of dulaglutide. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Trulicity Package Insert, 2017).

Enclosed Prescribing Information

TRULICITY® (dulaglutide) injection, for subcutaneous use, Lilly

Reference

Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.




Additional related information

Date of Last Review: August 03, 2017

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