Serious hypersensitivity reactions including anaphylaxis, angioedema & exfoliative skin conditions (eg, SJS); discontinue use if hypersensitivity reaction is suspected. Not for patients w/ type 1 DM. Not to be used for the treatment of diabetic ketoacidosis; discontinue or consider temporary interruption if ketoacidosis is suspected. Patients w/ predisposing factors to ketoacidosis including low β-cell function reserve resulting from pancreatic disorders (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), reduced insulin dose, caloric intake or increased insulin requirements due to infections, illness or surgery & alcohol abuse. Combination w/ medications known to cause hypoglycaemia eg, insulin & insulin secretagogues (eg, sulfonylureas). Discontinue use if pancreatitis is suspected. Patients w/ history of pancreatitis. Arthralgia; individually assess drug therapy continuation if patient presents w/ severe joint pain. Discontinue use if a patient develops blisters or erosions during therapy & bullous pemphigoid is suspected & consider referral to a dermatologist. Patients whom a dapagliflozin-induced BP drop could pose a risk (eg, patients w/ known CV disease, on an anti-hypertensive therapy w/ a history of hypotension or elderly patients). Monitor vol status (eg, physical exam, BP measurements, lab tests including haematocrit) & electrolytes in patients w/ intercurrent conditions may lead to vol depletion; consider temporary interruption for patients who develop vol depletion. Patients experiencing a symptom combination of pain, tenderness, erythema, or swelling in the genital or perineal area, w/ fever or malaise; discontinue use if Fournier's gangrene is suspected & institute prompt treatment. May affect the ability to drive or operate machines. Not to be used on patients w/ renal impairment (eGFR <45 mL/min/1.73 m
2); evaluate renal function prior to treatment initiation & periodically thereafter. Not to be used in patients w/ severe hepatic impairment. Not to be used during pregnancy & lactation. Paed & adolescents. Elderly.
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