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Trulicity ® (dulaglutide)
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How should other medications be administered with Trulicity® (dulaglutide)?
Consider a reduction of insulin and/or sulfonylurea dose to address the risk of hypoglycaemia. Dulaglutide delays gastric emptying and can alter the absorption of oral medications with rapid absorption or prolonged release.
Differences in the risk of hypoglycaemia from concomitant use of dulaglutide and other antidiabetics
Insulin or sulphonylurea
Patients receiving dulaglutide in combination with sulphonylurea or insulin may have an increased risk of hypoglycaemia.1
- The risk of hypoglycaemia may be lowered by a reduction in the dose of sulphonylurea or insulin.
- Blood glucose self-monitoring is usually not required with dulaglutide, but 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
SGLT2i or pioglitazone
When dulaglutide is added to an existing therapy with
- metformin and/or sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy or
- metformin and/or pioglitazone
the current dose of metformin and/or SGLT2i or pioglitazone, respectively, can be continued.1
Potential for dulaglutide to influence the pharmacokinetics of other drugs
Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products.1
In the clinical pharmacology studies including
- paracetamol
- atorvastatin
- digoxin
- the antihypertensives lisinopril and metoprolol
- warfarin
- the contraceptives norgestimate and ethinylestradiol
- metformin
dulaglutide doses up to 1.5 mg did not affect the absorption of the orally administered medicinal products tested to any clinically relevant degree.1
For the 4.5 mg dose, absence of major clinically relevant interactions was predicted by physiologically-based pharmacokinetic (PBPK) modelling simulations.1
No dose adjustment of the medicinal products as listed above is necessary when administered with dulaglutide.1
For patients receiving dulaglutide in combination with oral medicinal products with rapid gastrointestinal absorption or prolonged release, there is a potential for altered medicinal product exposure, particularly at the time of dulaglutide treatment initiation.1
There is limited experience with the use of concomitant medications in clinical trials with dulaglutide doses of 3 mg and 4.5 mg.2
Potential for co-administered drugs to influence the pharmacokinetics of dulaglutide
Compared with dulaglutide being taken alone, the coadministration of a single dose of dulaglutide 1.5 mg with steady-state sitagliptin 100 mg resulted in increases for dulaglutide
- area under the time-concentration curve (AUC) by approximately 38%
- maximum observed drug concentration (Cmax) by approximately 27%, and
- median time to maximum concentration (Tmax) of approximately 24 hours.3
These differences in the pharmacokinetic profile are not considered clinically relevant.3
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.
3Geiser J, de la Peña A, Cui X, et al. No dose adjustment is needed when coadministering dulaglutide with once-daily sitagliptin. Poster presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting: March 15-18, 2017; Washington, D.C.
Date of Last Review: 06 June 2023