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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).
Should Trulicity® (dulaglutide) therapy be modified for surgical procedures or hospitalization?
The use of dulaglutide in patients undergoing surgical procedures or hospitalization has not been evaluated. For additional considerations please see below.
Overview
Drug Interactions
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 described in the Trulicity label information (section 4.5 Interaction with other medicinal products and other forms of interaction), 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
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
For full information on drug interactions please refer to the Trulicity summary of product characteristics (SmPC).
Precautions
Pancreatitis
Use of GLP‑1 receptor agonists has been associated with a risk of developing acute pancreatitis. In clinical trials, acute pancreatitis has been reported in association with dulaglutide.1
Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, dulaglutide should be discontinued. If pancreatitis is confirmed, dulaglutide should not be restarted. In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis.1
Use in combination with Insulin or Sulfonylurea
Patients receiving dulaglutide in combination with sulphonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of sulphonylurea or insulin.1
Renal or hepatic impairment
Renal impairment
No dose adjustment is required in patients with mild, moderate or severe renal impairment (eGFR < 90 to ≥ 15 mL/min/1.73 m2).1
There is very limited experience in patients with end stage renal disease (< 15 mL/min/1.73 m2), therefore dulaglutide can not be recommended in this population.1
Dehydration, sometimes leading to acute renal failure or worsening renal impairment, has been reported in patients treated with dulaglutide, especially at the initiation of treatment.1
Many of the reported adverse renal events occurred in patients who had experienced nausea, vomiting, diarrhoea, or dehydration.1
Patients treated with dulaglutide should be advised of the potential risk of dehydration, particularly in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.1
Hepatic impairment
No dose adjustment is required in patients with hepatic impairment.1
For full information on precautions and other prescribing information please refer to the Trulicity SmPC.
Pharmacokinetic background information
Following subcutaneous administration to patients with type 2 diabetes, dulaglutide reaches peak plasma concentrations in 48 hours.1
Steady‑state plasma concentrations were achieved between 2 to 4 weeks of once‑weekly administration of dulaglutide (1.5 mg).1
The elimination half-life was approximately 5 days.1
For full information on pharmacokinetics please refer to the Trulicity SmPC.
References
1Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
Date of Last Review: 04 November 2021