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Trulicity Summary of Product Characteristics (SmPC)
Trulicity® (dulaglutide): Hypersensitivity Including Anaphylactic Reactions and Angioedema
Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with dulaglutide.
Detailed
Information
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
References
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:April 06, 2020
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