SIDAPVIA

What it is

SIDAPVIA contains dapagliflozin propanediol monohydrate 10 mg and sitagliptin phosphate monohydrate 100 mg in film-coated tablets. SIDAPVIA combines the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin and the dipeptidyl peptidase 4 (DPP4) inhibitor sitagliptin with distinct and complementary mechanisms of action to improve glycaemic control.

Approved indications

— SIDAPVIA is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and sitagliptin is appropriate.

Dosing overview

The recommended dose of SIDAPVIA is one dapagliflozin 10 mg/sitagliptin 100 mg tablet taken orally once daily at any time of the day, with or without food. SIDAPVIA should be used in combination with metformin unless contraindicated or not tolerated.

Key safety warnings

SIDAPVIA should not be used in patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m². SIDAPVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. There have been reports of ketoacidosis, including diabetic ketoacidosis, a serious life-threatening condition requiring urgent hospitalisation in patients taking dapagliflozin and other SGLT2 inhibitors, with fatal cases reported in patients taking dapagliflozin. Patients treated with SIDAPVIA who present with signs and symptoms consistent with ketoacidosis, including nausea, vomiting, abdominal pain, malaise and shortness of breath, should be assessed for ketoacidosis even if blood glucose levels are below 14 mmol/L. If ketoacidosis is suspected, SIDAPVIA should be suspended and prompt treatment initiated. The diuretic effect of dapagliflozin is a potential concern for volume-depleted patients. Due to its mechanism of action, dapagliflozin induces osmotic diuresis which may lead to a modest decrease in blood pressure. Initiation of therapy with dapagliflozin is not recommended in patients for whom the additional diuretic effect would be a potential concern due to acute illness or a history of hypotension or dehydration. There have been post-marketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalisation in patients receiving SGLT2 inhibitors, including dapagliflozin, with urinary tract infections reported more frequently for dapagliflozin 10 mg compared to control. Post-marketing cases of necrotising fasciitis of the perineum (also known as Fournier's gangrene), a rare but serious and potentially life-threatening necrotising infection, have been reported in patients with diabetes mellitus treated with SGLT2 inhibitors including dapagliflozin, with serious outcomes including hospitalisation, multiple surgeries, and death. Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported, 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 some reports occurring after the first dose. There have been reports of acute pancreatitis, including fatal and non-fatal haemorrhagic or necrotising pancreatitis. SIDAPVIA should not be used in patients with severe hepatic impairment.

Contraindications

SIDAPVIA is contraindicated in patients with a history of any hypersensitivity reaction to the active substances or to any of the excipients.

PBS listing

No information on PBS listing is available in the provided documents.

Regulatory history

Sidapvia, a fixed-dose combination of dapagliflozin and sitagliptin, was approved by the TGA on 24 May 2024 for the treatment of type 2 diabetes mellitus. In March 2024, the PBAC recommended SIDAPVIA for type 2 diabetes mellitus. SIDAPVIA 10/100 was first listed on the ARTG on 7 June 2024.