Please use a minimum of three unique search words
Our search is configured to only display links relevant to answer your question. For the best results please use specific and relevant keywords that accurately reflect the information you are seeking.
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at UK: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
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).
How should Trulicity® (dulaglutide) be dosed?
The approved dosing of once weekly dulaglutide for use in the EU is 0.75 mg as monotherapy and 1.5 mg as add-on therapy with optional dose escalations to 3 mg and 4.5 mg.
Approved Dulaglutide Dosage in the EU label
Monotherapy
The recommended dose of dulaglutide is 0.75 mg once weekly as monotherapy.1
Add-on Therapy
The recommended dose of dulaglutide is 1.5 mg once weekly as add-on therapy.1
For potentially vulnerable populations 0.75 mg once weekly can be considered as a starting dose.1
Optional dose escalation as add-on therapy
For additional glycaemic control,
- the 1.5 mg dose may be increased after at least 4 weeks to 3 mg once weekly
- the 3 mg dose may be increased after at least 4 weeks to 4.5 mg once weekly.
The maximum dose is 4.5 mg once weekly1
Do I need to adjust the Dose when using Dulaglutide as add-on with other antihyperglycemic Medication?
When Dulaglutide is added to |
Dose adjustment needed/not needed |
existing metformin and/or pioglitazone therapy... |
...the current dose of metformin and/or pioglitazone can be continued. |
existing metformin and/or SGLT2ia therapy... |
...the current dose of metformin and/or SGLT2i can be continued. |
existing therapy of a sulphonylurea or insulin... |
...a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia. |
aSGLT2i = sodium-glucose co-transporter 2 inhibitor
The use of dulaglutide does not require blood glucose self‑monitoring. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when dulaglutide therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended.1
What are the Reasons behind the approved Dosages?
Based on the review by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the dulaglutide dosages listed above were approved in the Trulicity Summary of Product Characteristics for use in the EU in 2014 and in 2020 for the 2 additional doses.1-3
The CHMP noted, that when used as monotherapy or in combination with other antihyperglycemic medications, dulaglutide administered once weekly produced a significant and clinically relevant effect on
- the primary endpoint of change in glycated hemoglobin (HbA1c) from baseline, and
- secondary endpoints. 2
Why 0.75 mg as Mono- and 1.5 mg as Add-on-Therapy?
Treatment with dulaglutide 1.5 mg once weekly was shown to be slightly more efficacious than dulaglutide 0.75 mg once weekly. However, treatment with dulaglutide 0.75 mg also achieved clinically relevant reductions in HbA1c with consistent results on secondary glycemic endpoints. Conversely, treatment with dulaglutide 0.75 mg resulted in a slightly better tolerability and safety profile than dulaglutide 1.5 mg 2.
The tolerability and safety profile of dulaglutide as monotherapy was similar to metformin but overall more favorable with the dulaglutide 0.75 mg dose with generally less gastrointestinal effects and a lower risk of hypoglycemia 2. The risk-to-benefit ratio was greater at the lower dose of dulaglutide 0.75 mg when used alone in patients who could not take metformin or when used in elderly patients over 75 years of age.2
Based on their assessment, the CHMP concluded that
- dulaglutide 0.75 mg once weekly be approved for the monotherapy indication, and
- dulaglutide 1.5 mg once weekly be approved as add-on therapy with dulaglutide 0.75 mg once weekly suggested as a starting dose for add-on therapy for potentially vulnerable patients 2.
References
1Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Committee for Medicinal Products for Human Use (CHMP); European Medicines Agency. Assessment report: Trulicity. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002825/WC500179473.pdf. Published September 25, 2014. Accessed November 27, 2017.
3Committee for Medicinal Products for Human Use (CHMP); European Medicines Agency. Variation report: Trulicity.https://www.ema.europa.eu/en/documents/variation-report/trulicity-h-c-2825-x-0045-epar-assessment-report-variation_en.pdf Published September 17, 2020. Accessed July 9, 2021.
Date of Last Review: 08 July 2021
Contact Lilly
Call or Email us
If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com
Available Mon - Fri, 10am - 4pm, excluding Bank Holidays