Exercise caution in patients for whom a dapagliflozin-induced drop in BP could pose a risk (eg, patients on anti-hypertensive therapy w/ history of hypotension or elderly). Monitor vol status in case of intercurrent conditions that may lead to vol depletion. Temporary interruption of treatment is recommended for patients who develop vol depletion until the depletion is corrected. Should not be used for treatment of patients w/ type 1 diabetes. Rare reports of diabetic ketoacidosis (DKA). Immediately stop treatment in patients where DKA is suspected or diagnosed. Interrupt treatment in patients who are hospitalised for major surgical procedures or acute serious medical illnesses; monitor ketones in these patients. Reports of necrotising fasciitis of the perineum (Fournier's gangrene). Discontinue dapagliflozin & institute prompt treatment (antibiotics & surgical debridement) if Fournier's gangrene is suspected. Urinary glucose excretion may be associated w/ increased risk of UTI; consider temporary interruption of dapagliflozin when treating pyelonephritis or urosepsis. Increased cases of lower limb amputation (primarily of the toe); counsel patients w/ diabetes on routine preventative foot care. Patients taking dapagliflozin will test +ve for glucose in the urine. Should not be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended to initiate treatment in patients w/ eGFR <15 mL/min/1.73 m
2. Reduced glucose lowering efficacy in patients w/ eGFR <45 mL/min/1.73 m
2 & likely absent in patients w/ severe renal impairment. Increased exposure in patients w/ severe hepatic impairment. Limited experience in NYHA class IV. No experience for treatment of CKD in patients w/o diabetes who do not have albuminuria. Has not been studied for treatment of CKD in patients w/ polycystic kidney disease, glomerulonephritis w/ flares (lupus nephritis or ANCA-associated vasculitis), ongoing or recent requirements of cytotoxic, immunosuppressive or other immunomodulating renal therapy, or in patients who received an organ transplant. Safety & efficacy for treatment of heart failure or CKD in childn <18 yr have not yet been established. Not recommended during 2nd & 3rd trimesters of pregnancy. Discontinue treatment when pregnancy is detected. Should not be used while breast-feeding. No data available for childn <10 yr. Elderly patients may be at greater risk for vol depletion & renal function changes.
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