JANTRA

What it is

Jantra is a film-coated tablet containing sitagliptin hydrochloride. Each tablet contains 25 mg, 50 mg or 100 mg of sitagliptin.

Approved indications

Jantra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: — Monotherapy when metformin is considered inappropriate due to intolerance. — In combination with other anti-hyperglycaemic agents, including insulin.

Dosing overview

The recommended dose of Jantra is 100 mg once daily as monotherapy, or as combination therapy with metformin, or a sulfonylurea, insulin (with or without metformin), a thiazolidinedione, or combination therapy with metformin and a sulfonylurea. Jantra can be taken with or without food. Dose adjustment is required in renal impairment. For patients with eGFR ≥ 45 mL/min/1.73 m² to < 90 mL/min/1.73 m², no dosage adjustment is required. For patients with eGFR ≥ 30 mL/min/1.73 m² to < 45 mL/min/1.73 m², the dose is 50 mg once daily. For patients with eGFR ≥ 15 mL/min/1.73 m² to < 30 mL/min/1.73 m² or with end-stage renal disease (eGFR < 15 mL/min/1.73 m²), including those requiring dialysis, the dose is 25 mg once daily.

Key safety warnings

There have been reports of acute pancreatitis, including fatal and non-fatal haemorrhagic or necrotising pancreatitis, in patients taking sitagliptin. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of sitagliptin. There have been postmarketing reports of serious hypersensitivity reactions in patients treated with sitagliptin, including anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first three months after initiation of treatment, with some reports occurring after the first dose. There have been post-marketing reports of joint pain, which may be severe, in patients taking DPP-4 inhibitors. Onset of symptoms following initiation of treatment may be rapid or may occur after longer periods. Postmarketing cases of bullous pemphigoid requiring hospitalisation have been reported with DPP-4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulfonylurea. When Jantra is used in combination with a sulfonylurea or with insulin, reduction in the dose of sulfonylurea or insulin may be considered to reduce the risk of sulfonylurea- or insulin-induced hypoglycaemia.

Contraindications

Sitagliptin is contraindicated in patients who are hypersensitive to any components of this product.

PBS listing

No information regarding PBS listing is available in the provided documents.

Regulatory history

Jantra was first registered on the Australian Register of Therapeutic Goods on 11 July 2022, with registrations for 25 mg, 50 mg and 100 mg film-coated tablets in both blister pack and bottle presentations.