Trulicity - your answer to diabetes

Trulicity
trulicityinfo

TrulicityTM is a GLP-1 RA that offers adults with type 2 diabetes:

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* Trulicity 1.5 mg demonstrated statistically superior HbA1c reduction in 5 phase III registration trials vs metformin, sitagliptin, exenatide BID, and insulin glargine. Trulicity 1.5 mg demonstrated statistically noninferior HbA1c reduction vs liraglutide 1.8 mg in a phase III trial. 1

Therapeutic indications

Trulicity is indicated in adults with type 2 diabetes mellitus to improve glycaemic control as:

Monotherapy
When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.

Add-on therapy
In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Posology and method of administration

Posology

Monotherapy
The recommended dose is 0.75 mg once weekly.

Add-on therapy
The recommended dose is 1.5 mg once weekly.
For potentially vulnerable populations, such as patients ≥ 75 years, 0.75 mg once weekly can be considered as a starting dose.

When Trulicity is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued. When it is added to existing therapy of a sulphonylurea or prandial insulin, a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia.

The use of Trulicity does not require blood glucose self‑monitoring. Self‑monitoring may be necessary to adjust the dose of sulphonylurea or prandial insulin.

Elderly patients
No dose adjustment is required based on age. However, the therapeutic experience in patients ≥ 75 years is very limited, and in these patients 0.75 mg once weekly can be considered as a starting dose.

Patients with renal impairment
No dosage adjustment is required in patients with mild or moderate renal impairment. There is very limited experience in patients with severe renal impairment (eGFR [by CKD‑EPI] < 30 ml/min/1.73 m2) or end stage renal disease, therefore Trulicity is not recommended in this population.

Patients with hepatic impairment
No dosage adjustment is required in patients with hepatic impairment.

Paediatric population
The safety and efficacy of dulaglutide in children aged less than 18 years have not yet been established. No data are available.

Special warnings and Special precautions

Dulaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Use of GLP‑1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients with impaired renal function since these events, i.e. nausea, vomiting, and/or diarrhoea, may cause dehydration which could cause a deterioration of renal function. Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

Acute 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.

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.

Hypoglycaemia
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.

Populations not studied
There is limited experience in patients with congestive heart failure.

Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per 1.5 mg dose, i.e. essentially ‘sodium‑ free’.

Please click to access Prescribing Information.

Please see Instructions for Use included with the pen.

References

  1. Trulicity (Product Information), Eli Lilly India 2015
  2. Trulicity Instructions for Use
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