TRAJENTA

What it is

TRAJENTA is a film-coated tablet containing 5 mg linagliptin. Linagliptin is an inhibitor of the enzyme DPP-4 (Dipeptidyl peptidase 4), which is involved in the inactivation of the incretin hormones GLP-1 and GIP.

Approved indications

TRAJENTA is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in conjunction with diet and exercise, in the following settings: — As monotherapy when metformin and sulfonylureas are not tolerated or are contraindicated. — As add-on therapy to metformin. — As add-on therapy to sulfonylureas. — As add-on therapy to metformin plus sulfonylureas. — As add-on therapy to insulin, with or without metformin. — As add-on therapy to metformin plus SGLT2 inhibitors.

Dosing overview

The recommended dose is 5 mg once daily. TRAJENTA can be taken with or without a meal at any time of the day. No dose adjustment is necessary for elderly patients. No dosage adjustment is required for patients with renal impairment. No dosage adjustment is required for patients with hepatic impairment.

Key safety warnings

TRAJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Acute pancreatitis has been observed in patients taking linagliptin, and if pancreatitis is suspected, TRAJENTA should be discontinued. Sulfonylureas and insulin are known to cause hypoglycaemia; therefore, caution is advised when linagliptin is used in combination with a sulfonylurea or insulin, and a dose reduction of the sulfonylurea or insulin may be considered. Bullous pemphigoid has been observed in patients taking linagliptin, and if bullous pemphigoid is suspected, TRAJENTA should be discontinued. There have been postmarketing reports of joint pain, which may be severe, in patients taking DPP-4 inhibitors, with onset of symptoms that may be rapid or occur after longer periods; discontinuation of therapy should be considered in patients who present with or experience an exacerbation of joint symptoms during treatment with linagliptin.

Contraindications

TRAJENTA is contraindicated in patients with hypersensitivity to the active ingredient or to any of the excipients.

PBS listing

TRAJENTA 5 mg tablets are listed on the PBS with 2 items, under a streamlined restriction, with an ex-manufacturer price of A$38.36.

Regulatory history

TRAJENTA linagliptin 5 mg film-coated tablets were first registered on the ARTG on 1 November 2011. The TGA approved the extension of indications for TRAJENTA in 2013, allowing its use as monotherapy when metformin and sulfonylureas are not tolerated or contraindicated, and as an add-on to insulin (with or without metformin) for adult patients with type 2 diabetes mellitus. In March 2016, the PBAC recommended PBS listing of linagliptin in triple oral combination with metformin and a sulfonylurea on a cost-minimisation basis with sitagliptin. Also in March 2016, the PBAC recommended an Authority Required (Streamlined) listing of linagliptin for treatment of type 2 diabetes mellitus in combination with insulin, on a cost-minimisation basis with dapagliflozin in combination with insulin.