Forxiga Special Precautions

Use in patients with renal impairment: There is limited experience with FORXIGA in patients with severe renal impairment (eGFR <25 mL/min/1.73 m²) or end-stage renal disease (ESRD).
Use in patients with diabetes mellitus: FORXIGA is not recommended for use in the treatment of diabetes to improve glycemic control when eGFR is persistently below 45 mL/min/1.73 m² as the glycemic efficacy of dapagliflozin is dependent on renal function. Renal function should be evaluated prior to initiation of FORXIGA and periodically thereafter.
Use in patients at risk for volume depletion: Due to its mechanism of action, dapagliflozin increases diuresis which may lead to the modest decrease in blood pressure observed in clinical studies (see Pharmacology: Pharmacodynamics under Actions). It may be more pronounced in patients with very high blood glucose concentrations.
Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients on anti-hypertensive therapy with a history of hypotension or elderly patients.
In case of intercurrent conditions that may lead to volume depletion (e.g. gastrointestinal illness), careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit and electrolytes) is recommended. Temporary interruption of treatment with dapagliflozin is recommended for patients who develop volume depletion until the depletion is corrected.
Ketoacidosis in patients with diabetes mellitus: Predisposing factors to ketoacidosis include a low beta-cell function reserve resulting from pancreatic disorders (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction, reduced caloric intake or increased insulin requirements due to infections, illness or surgery and alcohol abuse. FORXIGA should be used with caution in these patients.
Patients treated with FORXIGA 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 (250 mg/dL). If ketoacidosis is suspected, discontinuation or temporary interruption of FORXIGA should be considered and the patient should be promptly evaluated.
There have been reports of ketoacidosis, including diabetic ketoacidosis (DKA), in patients with type 2 diabetes mellitus taking FORXIGA and other SGLT2 inhibitors.
Use with medications known to cause hypoglycemia: Insulin and insulin secretagogues, such as sulfonylureas, cause hypoglycemia. Therefore, a lower dose of insulin or the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with FORXIGA (see Pharmacology: Pharmacodynamics under Actions).
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.