JANUVIA

What it is

JANUVIA is available for oral use as film coated tablets containing sitagliptin phosphate monohydrate equivalent to 25, 50 or 100 mg of free base. 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

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

Dosing overview

The recommended dose of JANUVIA 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. Dosing adjustments are required for patients with renal impairment. For patients with eGFR ≥ 45 mL/min/1.73 m² to < 90 mL/min/1.73 m², no dosage adjustment for JANUVIA is required. For patients with eGFR ≥ 30 mL/min/1.73 m² to < 45 mL/min/1.73 m², the dose of JANUVIA 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 JANUVIA 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, JANUVIA and other potentially suspect medicinal products should be discontinued. **Hypersensitivity reactions.** There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA. 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 JANUVIA, 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 JANUVIA was used in combination with insulin or a sulfonylurea. To reduce the risk of sulfonylurea- or insulin-induced hypoglycaemia, reduction in the dose of sulfonylurea or insulin may be considered. **Joint pain.** There have been post-marketing reports of joint pain, which may be severe, in patients taking DPP-4 inhibitors. **Bullous pemphigoid.** Postmarketing cases of bullous pemphigoid requiring hospitalisation have been reported with DPP-4 inhibitor use. Tell patients to report development of blisters or erosions while receiving JANUVIA. If bullous pemphigoid is suspected, JANUVIA should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.

Contraindications

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

Regulatory history

JANUVIA sitagliptin phosphate monohydrate tablets in strengths of 25 mg, 50 mg and 100 mg were first listed on the ARTG on 2 August 2023.