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Diabetes mellitus type 2 Clinical criteria: The treatment must be in combination with metformin; unless contraindicated/intolerant, AND Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Treatment criteria: Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.
Chronic heart failure Clinical criteria: Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug, AND Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%, AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated, AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated, AND Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.
“Dapagliflozin is a reversible competitive inhibitor of sodium glucose co-transporter 2 (SGLT2) with nanomolar potency that improves glycaemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption leading to urinary glucose excretion (glucuresis).”
“The mean plasma terminal half-life (t 1/2 ) for dapagliflozin was 12.9 hours following a single oral dose of Dapagliflozin 10 mg to healthy subjects.”
Working under the parallel aged-care framework? Aged-care equivalent →
Chronic kidney disease Clinical criteria: Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug, AND Patient must have an estimated glomerular filtration rate of between 20 to 90 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug, AND Patient must have an estimated glomerular filtration rate of between 45 to 90 mL/min/1.73 m2 inclusive, with a urinary albumin to creatinine ratio of at least 200 mg/g (22.6 mg/mmol) prior to initiating treatment with this drug; OR Patient must have an estimated glomerular filtration rate of between 20 to 45 mL/min/1.73 m2 inclusive, with any level of urinary albumin to creatinine ratio prior to initiating treatment with this drug, AND Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant, AND Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor, AND Patient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug. Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug.
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“The formation of dapagliflozin 3-O-glucuronide is mediated by UGT1A9, an enzyme present in the liver and kidney, and CYP mediated metabolism was a minor clearance pathway in humans.”