Trulicity ® (dulaglutid) injektion

För fullständig produktresumé för Trulicity® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Hur ska Trulicity® (dulaglutid) doseras?

Den godkända dosen av dulaglutid en gång i veckan för användning i EU är 0,75 mg som monoterapi och 1,5 mg som tilläggsbehandling med valfri dosökning till 3 mg och 4,5 mg.

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en-GB

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?

Dose adjustment when Dulaglutide is used as add-on1

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.

Datum fӧr senaste ӧversyn 2021 M07 08


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