G-5.3 GLP-1 Analogues- formulation(Dulaglutide)

Name of Medicine

Dulaglutide

Presentation

Trulicity contains dulaglutide (rch) 1.5 mg per 0.5 mL solution.

Key Practice Points

Therapeutic Indications:

For the latest PBS indications for dulaglutide please see

https://www.pbs.gov.au/pbs/search?term=dulaglutide&search-type=medicines&analyse=false

Dose:

Trulicity should be administered once weekly on the same day. It can be given at any time of the day, without regard to meals. Trulicity should be injected subcutaneously in the abdomen, thigh, or upper arm.Do not inject Trulicity intravenously or intramuscularly.
Renal impairment: No dose adjustment is required in individuals with renal impairment. However, there is limited experience in end-stage renal disease (creatinine clearance < 15 mL/min requiring dialysis treatment). Therefore, Trulicity cannot be recommended in this population.
Use in Hepatic Impairment
No dose adjustment is required based on hepatic impairment.

Elderly:

No dose adjustment is required based on age.

Precautions:

Children:

Use in children and adolescents. The safety and effectiveness of Trulicity have not been established in children and adolescents under 18 years of age.

Gastrointestinal disease:

Dulaglutide has not been studied in individuals with any form of severe gastrointestinal disease, including gastroparesis.
Note: Diabetes MedsCheck side effect profile, prevention of complications, referral to appropriate allied health care team.

Acute pancreatitis:

Pancreatitis has been reported with use of all GLP-1 receptor agonists, including dulaglutide. individuals should be informed of the symptoms of acute pancreatitis. If acute pancreatitis is suspected Trulicity should be discontinued until evaluation is completed.

Adverse Effects:

Gastrointestinal disorders:

Nausea, vomiting and diarrhoea- typically mild or moderate in severity. These usually occurred in the first two weeks of starting the medication and settled in the 4-6 weeks of continuation.

Injection site reactions:

Rash, erythema-usually mild.

Cardiac arrhythmia:

Atrial fibrillation was experienced in trials compared to placebo.
Note: Diabetes MedsCheck for side effect profile with referral to GP if symptoms of this occur.

Hypoglycaemia:

Dulaglutide does not cause hypoglycaemia on its own. However, when used in conjunction with sulfonylureas or insulin hypoglycaemia can occur.

Weight loss:

Trulicity 1.5 mg was associated with sustained weight reduction over the duration of studies (0.35 kg to -2.88 kg). While the weight loss was seen to be grater in the group with nausea, there was still a significant loss in those who reported little to no feeling of nausea.

Contraindications:

Hypersensitivity to dulaglutide or any active ingredient

Pharmacokinetic Properties - Summary

Absorption:

Following subcutaneous injection, dulaglutide reaches peak plasma concentrations in 48 hours.
Steady state plasma concentrations were achieved after 2 to 4 weeks of once weekly administration of dulaglutide 1.5 mg.

Distribution:

The mean volume of distribution after subcutaneous administration of dulaglutide 1.5 mg to steady state in individuals approximately 17.4 L.

Metabolism:

Dulaglutide is presumed to be degraded into its component amino acids by general protein catabolism pathways.

Elimination:

The mean apparent clearance of dulaglutide in humans at steady state was 0.107 L/h with an elimination half-life of 4.7 days.

Hepatic impairment:

There does not seem to be any significantly relevant dose adjustment in this population.

For more detailed information on this product please consult the product information.

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-01412-1

More Information

For more detailed information on this product please consult the product information.

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=%20Dulaglutide&r=/