Forxiga Special Precautions

Use in patients with renal impairment: There is limited experience with initiating treatment with FORXIGA in patients with eGFR <25 mL/min/1.73 m².
The glucose lowering efficacy of dapagliflozin is dependent on renal function, and is reduced in patients where eGFR is <45 mL/min/1.73 m² (see Dosage & Administration).
Use in patients at risk for volume depletion: Due to its mechanism of action, FORXIGA induces osmotic diuresis which may lead to the modest decrease in blood pressure observed in clinical studies (see Pharmacology: Pharmacodynamics under Actions).
Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or elderly patients.
For patients receiving FORXIGA, in case of intercurrent conditions that may lead to volume depletion, careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended.
Temporary interruption of FORXIGA should be considered for patients who develop volume depletion.
Ketoacidosis in patients with diabetes mellitus: There have been reports of ketoacidosis, including diabetic ketoacidosis (DKA), in patients with type 1 and type 2 diabetes mellitus taking FORXIGA and other SGLT2 inhibitors. FORXIGA is not indicated for the treatment of patients with type 1 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.
Treatment should be interrupted in patients who are hospitalized for major surgical procedures or acute serious medical illnesses. Consider monitoring for ketoacidosis and temporarily discontinuing FORXIGA in other clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or post-surgery). Ensure risk factors for ketoacidosis are resolved prior to restarting FORXIGA.
Necrotising Fasciitis of the Perineum (Fournier's gangrene): Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking SGLT2 inhibitors (see Adverse Reactions). This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment.
Patients should be advised to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Be aware that either uro-genital infection or perineal abscess may precede necrotizing fasciitis. If Fournier's gangrene is suspected, FORXIGA should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
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 to use machines: No studies on the effects on the ability to drive and use machines have been performed.