Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutid): Magtömning

Dulaglutid försenar magtömning och försiktighet bör vidtas när dulaglutid ges samtidigt med orala läkemedel.

Detailed Information

Dulaglutide delays gastric emptying and has the potential to reduce the rate of absorption of concomitantly administered oral medications. The delay in gastric emptying is dose-dependent but is attenuated with the recommended dose escalation to higher doses of dulaglutide.1

In clinical pharmacology studies, dulaglutide 1.5 mg did not affect the absorption, to any clinically relevant degree, of the tested orally administered medications that included 

  • warfarin

  • metformin

  • lisinopril

  • metoprolol

  • digoxin

  • paracetamol

  • norelgestromin

  • ethinylestradiol

  • sitagliptin, and

  • atorvastatin.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. 2

Precautions

Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.2

Clinical Pharmacology Studies

In clinical pharmacology studies, dulaglutide 1.5 mg did not affect the absorption of the tested orally administered medications to a clinically relevant degree. There is limited experience with the use of concomitant medications in clinical trials with dulaglutide doses of 3 mg and 4.5 mg.1

The gastric emptying delay with dulaglutide administration has been demonstrated in 3 clinical pharmacology studies.1,3,4

In the first study, patients with T2DM were assigned to 1 of 6 dulaglutide doses that included 

  • 0.05 mg

  • 0.3 mg

  • 1 mg

  • 3 mg

  • 5 mg, and

  • 8 mg.

On 2 occasions, oral acetaminophen was administered and gastric emptying was assessed by following the absorption of acetaminophen.3

The maximum average delay in tmax of acetaminophen was approximately 1.5 hours, and there was a significant difference in the LSM ratio of predose to postdose tmax observed between dulaglutide 8 mg and placebo (tmax, 2.31; 90% CI: 1.28, 4.18). The results of the study suggested that gastric emptying was delayed by treatment with dulaglutide.3

In the second study, healthy subjects were assigned to dulaglutide 1 mg or dulaglutide 3 mg and received acetaminophen on 2 occasions to assess acetaminophen PKs. Steady-state levels of dulaglutide had no clinically significant effect on the rate or extent of gastric emptying according to the PKs of acetaminophen. However, the rate of gastric emptying 

  • was decreased after the first dulaglutide dose (reduced Cmax of acetaminophen: 1 mg, 36%; 3 mg, 50%), and

  • delayed the tmax of acetaminophen (1 mg, 3 hours; 3 mg, 4 hours).1

In the third study, scintigraphy was used in patients with T2DM to assess t50, defined as the time required for 50% of activity from a radiolabeled meal to empty from the stomach. Compared with baseline, delays in gastric emptying rate were observed following each of 4 dulaglutide 1.5 mg doses. The effect was most pronounced after the first dose of dulaglutide, with a mean increase in

  • t50 from 1.72 hours (on day 3, after placebo) to 3.77 hours (on day 10, after the first dose of dulaglutide), and

  • a corresponding 2.4-fold increase in AUC for residual activity.4

The results demonstrated that dulaglutide treatment delays gastric emptying by approximately 2 hours where the effect is largest after the first dose and diminishes with subsequent doses.4

References

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

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

3. Barrington P, Chien JY, Showalter HD, et al. A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes. Diabetes Obes Metab. 2011;13(5):426-433. https://doi.org/10.1111/j.1463-1326.2011.01364.x

4. Loghin C, de la Pena A, Cui X, Chien J. Gastric emptying effects of once weekly dulaglutide in patients with type 2 diabetes mellitus. Poster presented at: 23rd Annual American Association of Clinical Endocrinologists (AACE) Scientific and Clinical Congress: May 10-14, 2014; Las Vegas, NV.

Glossary

AUC = area under the curve

Cmax = maximum plasma concentration

GI = gastrointestinal

LSM = least squares mean

PK = pharmacokinetic

T2DM = type 2 diabetes mellitus

tmax = time to maximum concentration

Datum fӧr senaste ӧversyn 2018 M01 10


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