SITUVIA

What it is

SITUVIA is available 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

— 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. — As an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus in combination with other anti-hyperglycaemic agents, including insulin.

Dosing overview

The recommended dose of SITUVIA 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. SITUVIA can be taken with or without food. For patients with renal impairment, dosing adjustment is required based on estimated glomerular filtration rate (eGFR). For patients with eGFR ≥ 45 mL/min/1.73 m² to < 90 mL/min/1.73 m², no dosage adjustment for SITUVIA is required. For patients with eGFR ≥ 30 mL/min/1.73 m² to < 45 mL/min/1.73 m², the dose of SITUVIA 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 SITUVIA 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, SITUVIA and other potentially suspect medicinal products should be discontinued. **Hypersensitivity reactions.** There have been postmarketing reports of serious hypersensitivity reactions in patients treated with SITUVIA, including 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 SITUVIA, with some reports occurring after the first dose. **Hypoglycaemia with sulfonylureas or insulin.** Hypoglycaemia has been observed when SITUVIA was used in combination with insulin or a sulfonylurea. When SITUVIA 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. **Arthralgia.** There have been post-marketing reports of joint pain, which may be severe, in patients taking DPP-4 inhibitors, with onset of symptoms following initiation of treatment that may be rapid or occur after longer periods. **Bullous pemphigoid.** Postmarketing cases of bullous pemphigoid requiring hospitalisation have been reported with DPP-4 inhibitor use. Patients should be told to report development of blisters or erosions while receiving SITUVIA, and if bullous pemphigoid is suspected, SITUVIA should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.

Contraindications

SITUVIA is contraindicated in patients who are hypersensitive to any components of this product. SITUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

PBS listing

SITUVIA sitagliptin (as phosphate) is registered on the ARTG in 25 mg, 50 mg and 100 mg strengths in film-coated tablet form, available in blister pack and bottle presentations, with first listing on 2024-08-08.

Regulatory history

SITUVIA sitagliptin was first listed on the ARTG on 2024-08-08 as a registered medicine sponsored by Accord Healthcare.