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

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