D-3.4 Formulations-Sitagliptin Phosphate Monohydrate

• Treatment of type 2 diabetes in adults where physical activity and dietary management has not resulted in adequate glycaemic targets.
• Monotherapy when metformin is considered inappropriate due to intolerance; or
• in combination with other anti-hyperglycaemic agents, including insulin.

For the most up to date PBS therapeutic indications for sitagliptin, please see
https://www.pbs.gov.au/medicine/item/9180E-9181F-9182G

• The recommended dose of Januvia is 100 mg once daily, with or without food.
• Renal impairment:
  eGFR≥ 30 mL/min/1.73 m to < 45 mL/min/1.73 m , the dose of Januvia is 50 mg once daily. eGFR≥ 15 mL/min/1.73 m to < 30 mL/min/1.73 m or with ESRD(eGFR< 15 mL/min/1.73 m ), including those requiring haemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg once daily. Januvia maybe administered without regard to the timing of dialysis.

• No dosage adjustment is required in this age population.

• Type 1 diabetes – Januvia should not be used to treat type 1 diabetes or diabetic ketoacidosis.
• Pancreatitis – There have been reports of acute pancreatitis with all DPP4 inhibitors. If pancreatitis is suspected, Januvia should be discontinued.
• Renal impairment – Januvia is renally excreted. To achieve plasma concentrations similar to those in those with normal renal function, lower dosages are recommended in patients with eGFR< 45 mL/min/1.73 m, as well those requiring haemodialysis or peritoneal dialysis.

• Gastrointestinal disorders: Constipation.
• Infections and infestations: Pharyngitis.
• Vascular disorders: Hypertension. Gastrointestinal disorders: Acute pancreatitis, including fatal and nonfatal haemorrhagic and necrotising pancreatitis, constipation; vomiting.
• Musculoskeletal and connective tissue disorders: Arthralgia; myalgia; pain in extremity; back pain

• Hypersensitivity to sitagliptin or any of the excipients