Rhea Dapagliflozin Special Precautions

Use in Patients with Renal Impairment: There is limited experience with initiating treatment with Dapagliflozin 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).
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. Dapagliflozin should be used with caution in these patients.
Patients treated with Dapagliflozin 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 Dapagliflozin should be considered and the patient should be promptly evaluated.
There have been reports of ketoacidosis, including diabetic ketoacidosis (DKA), in patients with type 1 and type 2 diabetes mellitus taking Dapagliflozin and other SGLT2 inhibitors. Dapagliflozin is not indicated for the treatment of patients with type 1 diabetes mellitus.
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 Dapagliflozin (see Pharmacology: Pharmacodynamics under Actions).
Necrotizing fasciitis of the perineum (Fournier's gangrene): Post-marketing cases of necrotizing 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, Dapagliflozin should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.