SITAGLO

What it is

SITAGLO is a dipeptidyl peptidase 4 (DPP-4) inhibitor, a class of oral anti-hyperglycaemic agents that improve glycaemic control in patients with type 2 diabetes by enhancing the levels of active incretin hormones. SITAGLO is available as film-coated tablets containing 25 mg, 50 mg and 100 mg of sitagliptin as hydrochloride.

Approved indications

— 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. — 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 SITAGLO 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. SITAGLO can be taken with or without food. **Dosing adjustment in renal impairment:** For patients with eGFR ≥ 45 mL/min/1.73 m² to < 90 mL/min/1.73 m², no dosage adjustment for SITAGLO is required. For patients with eGFR ≥ 30 mL/min/1.73 m² to < 45 mL/min/1.73 m², the dose of SITAGLO 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 haemodialysis or peritoneal dialysis, the dose of SITAGLO 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, 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 sitagliptin, with some reports occurring after the first dose. **Hypoglycaemia with sulfonylureas or insulin.** Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulfonylurea. When SITAGLO 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 advised to report development of blisters or erosions while receiving sitagliptin, and if bullous pemphigoid is suspected, sitagliptin should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.

Contraindications

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

PBS listing

SITAGLO is not listed on the Pharmaceutical Benefits Scheme. Information on ex-manufacturer pricing and PBS status is not available in the provided source documents.

Regulatory history

SITAGLO was registered on the Australian Register of Therapeutic Goods on 2022-07-11 in six variants (25 mg and 100 mg tablets in blister pack and bottle formats, and 50 mg tablets in blister pack and bottle formats), all in licence category RE (registered export).