SITAGLIPTIN SANDOZ

What it is

Sitagliptin Mylan is available for oral use as film coated tablets containing sitagliptin hydrochloride 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, 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, as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

Dosing overview

The recommended dose of Sitagliptin Mylan is 100 mg once daily as monotherapy, or as combination therapy with metformin, or a sulfonylurea, insulin, a thiazolidinedione, or combination therapy with metformin and a sulfonylurea. Dosage adjustment is 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 Sitagliptin Mylan is required. For patients with eGFR ≥ 30 mL/min/1.73 m² to < 45 mL/min/1.73 m², the dose of Sitagliptin Mylan 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 Sitagliptin Mylan 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. 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 has been observed when sitagliptin 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. 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. Discontinuation of therapy should be considered in patients who present with or experience an exacerbation of joint symptoms during treatment with DPP-4 inhibitors. 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 Mylan is contraindicated in patients who are hypersensitive to any components of this product. Sitagliptin Mylan should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Regulatory history

Sitagliptin Mylan 25 mg, 50 mg, and 100 mg tablets were first listed on the ARTG on 6 April 2023.