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).

Detailed Information

Dulaglutide is contraindicated in patients who have had a prior serious hypersensitivity reaction to dulaglutide or to any of its product components.1

Serious hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with dulaglutide and other GLP-1 RAs.1

Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 RA other than dulaglutide because it is unknown whether these patients will be predisposed to anaphylaxis when receiving dulaglutide.1

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.1

Clinical Study Experience

Systemic hypersensitivity adverse reactions were experienced by 0.5% of patients who received dulaglutide in 4 phase 2 and 5 phase 3 studies that included

  • severe urticaria

  • systemic rash

  • facial edema, and 

  • lip swelling.1

Postmarketing Experience

There have been reports of anaphylactic reactions and angioedema during postapproval use of dulaglutide.1

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.1

Enclosed Prescribing Information

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

Reference

1. Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

Glossary

GLP-1 RA = glucagon-like peptide-1 receptor agonist

Date of Last Review: April 06, 2020

Contact Lilly

Call Us

If you need information about a Lilly product or want to report an Adverse Event or Product Complaint, you may call us.

Available Mon - Fri, 8am - 7pm ET

Or you can

Ask us a question Chat with us

Submit a Request

Visit Us @LillyMedical