Caution in patients for whom a dapagliflozin-induced drop in BP could pose a risk (eg, patients on antihypertensive therapy w/ history of hypotension or elderly patients); w/ low β-cell function reserve (eg, type 2 diabetes patients w/ low C-peptide or latent autoimmune diabetes in adults, or w/ history of pancreatitis), w/ conditions that lead to restricted food intake or severe dehydration, for whom insulin doses are reduced, & w/ increased insulin requirements due to acute medical illness, surgery or alcohol abuse. Carefully monitor vol status (eg, physical exam, BP measurements, lab tests including haematocrit & electrolytes) in case of intercurrent conditions that may lead to vol depletion (eg, GI illness). Temporarily interrupt treatment in patients who develop vol depletion until the depletion is corrected. Reports of diabetic ketoacidosis (DKA); post-marketing cases of Fournier's gangrene. Stop treatment immediately if diabetic ketoacidosis is suspected or diagnosed. Interrupt treatment in patients hospitalised for major surgical procedures or acute serious medical illnesses, & monitor ketones (blood ketone levels is preferred to urine) in these patients. Not to be used for treatment of type 1 diabetes. Discontinue treatment if Fournier's gangrene is suspected & institute prompt treatment. Urinary glucose excretion may be associated w/ increased risk of UTI; consider temporary interruption of treatment when treating pyelonephritis or urosepsis. Limited experience in NYHA class IV cardiac failure. No experience for treatment of CKD in patients w/o diabetes who do not have albuminuria. Not 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 those who received an organ transplant. Increase in cases of lower limb amputation (primarily of the toe) in long-term clinical studies in type 2 DM; counsel patients on routine preventative foot care. +ve result for glucose in urine. Limited experience in initiating treatment in patients w/ eGFR <25 mL/min/1.73 m
2. Not recommended to initiate treatment in patients w/ eGFR <15 mL/min/1.73 m
2. Glucose-lowering efficacy is reduced in patients w/ eGFR <45 mL/min/1.73 m
2 & is likely absent in patients w/ severe renal impairment. Higher proportion of patients had adverse reactions of increase in parathyroid hormone & hypotension compared w/ placebo in patients w/ moderate renal impairment (eGFR <60 mL/min/1.73 m
2). Limited experience in patients w/ hepatic impairment. Increased exposure in patients w/ severe hepatic impairment. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. No data for treatment of type 2 DM in childn <10 yr. Safety & efficacy of treatment of heart failure or CKD in childn <18 yr have not yet been established. Greater risk for vol depletion & more likely to have impaired renal function in elderly (≥65 yr).
Sign Out
Continue with Google
Sign Up With Email
Already a member?
Sign In
