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Trulicity ® (dulaglutide)
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Trulicity® (dulaglutide): Hypersensitivity Including Anaphylactic Reactions and Angioedema
Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with dulaglutide.
Dulaglutide is contraindicated in patients with a known hypersensitivity to dulaglutide or to any of the excipients.1
Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported in patients treated with dulaglutide and other glucagon-like peptide-1 receptor agonists. 2
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.2
Clinical Study Experience
In the phase II and phase III clinical studies, systemic hypersensitivity events (e.g., urticaria, oedema) were reported in 0.5 % of patients receiving dulaglutide.1
Postmarketing Experience
There have been reports of anaphylactic reactions and angioedema during postapproval use of dulaglutide.2
Reporting rates of anaphylactic reactions have been very rarely reported in patients receiving dulaglutide, <0.01%.2
1. Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
GLP-1 RA = glucagon-like peptide-1 receptor agonist
Date of Last Review: 06 April 2020
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