Trulicity® (dulaglutide): SmPC Dosing

Dulaglutide Dosage Approved in the Summary of Product Characteristics

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

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

When dulaglutide is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued. ¹

When dulaglutide is added to existing metformin and/or SGLT2i therapy, the current dose of metformin and/or SGLT2i can be continued. ¹

When dulaglutide is added to 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.¹

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

Dulaglutide Dosage Rationale

Based on the review by the European Medicines Agency’s CHMP, the dulaglutide dosages listed above were approved in the Trulicity Summary of Product Characteristics for use in the EU in 2014.^1,2

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

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.^2,3

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

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

2. Committee 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.

3. European Medicines Agency. EPAR summary for the public: Trulicity. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002825/WC500179472.pdf. Updated November 2014. Accessed November 27, 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002825/WC500179472.pdf

Glossary

EU = European Union

CHMP = Committee for Medicinal Products for Human Use

SGLT2i =  sodium-glucose co-transporter 2 inhibitor