Jardiance Special Precautions

Empagliflozin (Jardiance) should not be used in patients with type 1 diabetes.
Ketoacidosis: Cases of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, have been reported in patients with diabetes mellitus treated with empagliflozin, including fatal cases. In a number of reported cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL). Although ketoacidosis is less likely to occur in patients without diabetes mellitus, cases have also been reported in these patients.
The risk of ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level. If ketoacidosis is suspected, Empagliflozin (Jardiance) should be discontinued, patient should be evaluated, and prompt treatment should be instituted.
Patients who may be at higher risk of ketoacidosis while taking Empagliflozin (Jardiance) include patients on a very low carbohydrate diet (as the combination may further increase ketone body production), patients with an acute illness, pancreatic disorders suggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction (including insulin pump failure), alcohol abuse, severe dehydration, and patients with a history of ketoacidosis. Empagliflozin (Jardiance) should be used with caution in these patients. When reducing the insulin dose (see Dosage and Administration), caution should be taken. In patients treated with Empagliflozin (Jardiance) consider monitoring for ketoacidosis and temporarily discontinuing Empagliflozin (Jardiance) in clinical situations known to predispose to ketoacidosis (e.g. prolonged fasting due to acute illness or surgery). In these situations, consider monitoring of ketones, even if Empagliflozin (Jardiance) treatment has been interrupted.
Necrotizing fasciitis of the perineum (Fournier's gangrene): Cases of necrotizing fasciitis of the perineum (also known as Fournier's gangrene), a rare, but serious and life-threatening necrotizing infection, have been reported in female and male patients with diabetes mellitus treated with SGLT2 inhibitors, including empagliflozin. Serious outcomes have included hospitalisation, multiple surgeries, and death.
Patients treated with Empagliflozin (Jardiance) who present with pain or tenderness, erythema, swelling in the genital or perineal area, fever, malaise should be evaluated for necrotizing fasciitis. If suspected, Empagliflozin (Jardiance) should be discontinued and prompt treatment should be instituted (including broad-spectrum antibiotics and surgical debridement if necessary).
Use in patients with renal impairment: Due to limited experience, it is not recommended to initiate treatment with empagliflozin in patients on dialysis.
Glycaemic efficacy of empagliflozin is dependent on renal function and likely absent in patients with an eGFR <30 ml/min/1.73 m² (see Dosage & Administration).
Monitoring of renal function: Assessment of renal function is recommended prior to Empagliflozin (Jardiance) initiation and periodically during treatment, i.e., at least yearly.
Use in patients at risk for volume depletion: Based on the mode of action of SGLT2 inhibitors, osmotic diuresis accompanying glucosuria may lead to a modest decrease in blood pressure. Therefore, caution should be exercised in patients for whom an empagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on antihypertensive therapy with a history of hypotension or patients aged 75 years and older.
In case of conditions that may lead to fluid loss (e.g. gastrointestinal illness), careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving empagliflozin. Temporary interruption of treatment with Empagliflozin (Jardiance) should be considered until the fluid loss is corrected.
Complicated urinary tract infections: Cases of complicated urinary tract infections including pyelonephritis and urosepsis have been reported in patients treated with empagliflozin (see Adverse Reactions). Temporary interruption of Empagliflozin (Jardiance) should be considered in patients with complicated urinary tract infections.
Lactose: Empagliflozin (Jardiance) 10 mg and 25 mg tablets contain 162.5 mg and 113 mg of lactose per maximum recommended daily dose, respectively.
Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia should not take this medicine.
Sodium: Empagliflozin (Jardiance) contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.
Driving and Using Machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in the Elderly: Patients aged 75 years and older may be at increased risk of volume depletion, therefore, Empagliflozin (Jardiance) should be prescribed with caution in these patients (see Adverse Reactions).