JANORIX

What it is

Janorix contains sitagliptin hydrochloride. Each film-coated tablet of Janorix contains 25 mg, 50 mg and 100 mg of sitagliptin (as hydrochloride). Sitagliptin is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors, which improve glycaemic control in patients with type 2 diabetes by enhancing the levels of active incretin hormones.

Approved indications

— Improvement of glycaemic control in adults with type 2 diabetes mellitus as monotherapy when metformin is considered inappropriate due to intolerance. — Improvement of glycaemic control in adults with type 2 diabetes mellitus in combination with other anti-hyperglycaemic agents, including insulin.

Dosing overview

The recommended dose of Janorix is 100 mg once daily as monotherapy, or as combination therapy with metformin, or a sulfonylurea (clinical experience is with glimepiride as dual therapy), insulin (with or without metformin), a thiazolidinedione (clinical experience is with pioglitazone as dual therapy), or combination therapy with metformin and a sulfonylurea (clinical experience is with addition of sitagliptin to glimepiride or gliclazide and metformin as triple therapy). For patients with renal impairment, dosage adjustments are required. For patients with eGFR ≥ 45 mL/min/1.73 m² to < 90 mL/min/1.73 m², no dosage adjustment for Janorix is required. For patients with eGFR ≥ 30 mL/min/1.73 m² to < 45 mL/min/1.73 m², the dose of Janorix is 50 mg once daily. For patients with eGFR ≥ 15 mL/min/1.73 m² to < 30 mL/min/1.73 m² or with ESRD (eGFR < 15 mL/min/1.73 m²), including those requiring haemodialysis or peritoneal dialysis, the dose of Janorix is 25 mg once daily.

Key safety warnings

**Pancreatitis.** 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. If pancreatitis is suspected, sitagliptin and other potentially suspect medicinal products should be discontinued. **Hypersensitivity reactions.** There have been postmarketing reports of serious hypersensitivity reactions in patients treated with sitagliptin. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose. **Hypoglycaemia with sulfonylureas or insulin.** As typical with other antihyperglycaemic agents used in combination with sulfonylurea or with insulin, hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulfonylurea. Reduction in the dose of sulfonylurea or insulin may be considered to reduce the risk of sulfonylurea- or insulin-induced hypoglycaemia. **Arthralgia.** 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. **Bullous pemphigoid.** 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.

Contraindications

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

PBS listing

Information on PBS listing status, item numbers, restriction type, and ex-manufacturer price for Janorix is not provided in the available source documents.

Regulatory history

JANORIX sitagliptin (as hydrochloride) was registered on the ARTG on 2022-07-11 in three strengths: 25 mg, 50 mg, and 100 mg film-coated tablets in both bottle and blister pack configurations.