ONGLYZA

What it is

ONGLYZA is a film-coated tablet containing saxagliptin as the active ingredient, available in strengths of 2.5 mg and 5 mg.

Approved indications

— Add-on combination therapy in patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin, a sulfonylurea, or a thiazolidinedione, as an adjunct to diet and exercise, when the single agent alone does not provide adequate glycaemic control. — Initial combination therapy with metformin in patients with type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise, when dual saxagliptin and metformin therapy is appropriate (that is, high initial HbA1c levels and poor prospects for response to monotherapy).

Key safety warnings

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during postmarketing experience with saxagliptin. If a serious hypersensitivity reaction to saxagliptin is suspected, ONGLYZA should be discontinued, and alternative treatment for diabetes should be instituted. There have been spontaneously reported cases of acute pancreatitis during postmarketing experience, and patients should be informed of the characteristic symptom of persistent, severe abdominal pain. If pancreatitis is suspected, ONGLYZA should be discontinued. A small increase in the rate of hospitalisation for heart failure was observed in saxagliptin-treated patients compared to placebo in the SAVOR trial, although a causal relationship has not been established. Caution is warranted if ONGLYZA is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment. Joint pain, which may be severe, has been reported in postmarketing reports for DPP4 inhibitors. Patients experienced relief of symptoms after discontinuation of the medication and some experienced recurrence of symptoms with reintroduction of the same or another DPP4 inhibitor. Onset of symptoms following initiation of drug therapy may be rapid or may occur after longer periods of treatment.

Contraindications

ONGLYZA is contraindicated in patients with hypersensitivity to saxagliptin or to any of the excipients, or a history of any serious hypersensitivity reaction, including anaphylactic reaction and angioedema, to any dipeptidyl peptidase 4 (DPP4) inhibitor.

PBS listing

ONGLYZA 5 mg tablets and 2.5 mg tablets are listed on the PBS with streamlined restriction. The ex-manufacturer price is A$35.80.

Regulatory history

The 5 mg tablet of ONGLYZA was approved for registration on 7 March 2011 for the treatment of type 2 diabetes mellitus as add-on or initial combination therapy, while the 2.5 mg tablet was withdrawn from the submission. The 2.5 mg formulation was subsequently registered on the ARTG on 21 March 2014.