Trulicity ® (dulaglutide)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

Have hypersensitivity reactions been reported with Trulicity® (dulaglutide)?

Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with dulaglutide.

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Dulaglutide and Hypersensitivity

Dulaglutide is contraindicated in patients with known hypersensitivity to dulaglutide or to any of its components.1

Clinical Study Experience

In the phase 2 and phase 3 registration studies, systemic hypersensitivity events (e.g., urticaria, oedema) were reported in 0.5 % of patients receiving dulaglutide.  Cases of anaphylactic reaction have been rarely reported with marketed use of dulaglutide.1

Postmarketing (Spontaneous) Adverse Event Reports

Postmarketing data do not necessarily represent the rate of occurrence of an adverse event in a treated population, but they represent a reporting rate of a particular adverse event to the company. Spontaneous reporting of adverse events can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an adverse event.2

Spontaneous reporting has limited use due to

  • lack of control population
  • under-reporting or reporting bias, and
  • missing or incomplete information regarding patient's medical history or concomitant medications.2

The Eli Lilly and Company (Lilly) spontaneous adverse event database may also include reports of adverse events for products that may be available from Lilly and from other manufacturers. Although verification of product manufacturer is sought, this verification is not always obtainable. The default for these cases is to include them in the database.2

Cases of anaphylactic reaction have been reported with marketed use of dulaglutide.2 

Anaphylactic Reaction

Through September 18, 2021, the Medical Dictionary for Regulatory Activities (MedDRA) preferred term of anaphylactic reaction has been Very Rarely Reported in the Lilly spontaneous adverse event database, based on the estimated exposure of 9,987,000 patients. Very Rarely Reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.2

Angioedema

Through September 18, 2021, the MedDRA preferred term of angioedema has been Very Rarely Reported in the Lilly spontaneous adverse event database, based on the estimated exposure of 9,987,000 patients. Very Rarely Reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.2

Urticaria

Through September 18, 2021, the MedDRA preferred term of urticaria has been Very Rarely Reported in the Lilly spontaneous adverse event database, based on the estimated exposure of 9,987,000 patients. Very Rarely Reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.2

Oedema

Through September 18, 2021, the MedDRA preferred term of oedema has been Very Rarely Reported in the Lilly spontaneous adverse event database, based on the estimated exposure of 9,987,000 patients. Very Rarely Reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.2

References

1Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: 14 June 2022


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