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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.
is contraindicated in patients with a known hypersensitivity to
dulaglutide or to any of the excipients.1
hypersensitivity reactions including anaphylactic reactions and
angioedema have been reported in patients treated with dulaglutide
and other glucagon-like peptide-1 receptor agonists. 2
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
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
have been reports of anaphylactic reactions and angioedema during
postapproval use of dulaglutide.2
rates of anaphylactic reactions have been very rarely reported in
patients receiving dulaglutide, <0.01%.2
Trulicity [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
RA = glucagon-like peptide-1 receptor agonist
Date of Last Review:April 06, 2020
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