Jardiance Special Precautions

General: Jardiance should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Ketoacidosis: Cases of ketoacidosis, a serious life-threatening condition requiring urgent hospitalisation, 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, Jardiance should be discontinued, patients should be evaluated and prompt treatment should be instituted.
Patients who may be at higher risk of ketoacidosis while taking Jardiance include patients with 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 patient with a history of ketoacidosis. Jardiance should be used with caution in these patients. When reducing the insulin dose (see Dosage & Administration), caution should be taken. In patients treated with Jardiance, consider monitoring for ketoacidosis and temporarily discontinuing Jardiance in clinical situations known to predispose to ketoacidosis (e.g. prolong fasting due to acute illness or surgery). In these situations, consider monitoring of ketones, even if 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 hospitalization, multiple surgeries, and death.
Patients treated with 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, Jardiance should be discontinued and prompt treatment should be instituted (including broad-spectrum antibiotics and surgical debridement if necessary).
Hepatic injury: Cases of hepatic injury have been reported with empagliflozin in clinical trials. A causal relationship between empagliflozin and hepatic injury has not been established.
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 (see Pharmacology: Pharmacodynamics under Actions). 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 anti-hypertensive 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 should be considered until the fluid loss is corrected.
Complicated urinary tract infections: Cases of complicated urinary tract infections including pyelonephritis or urosepsis have been reported in patients treated with empagliflozin. Temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections.
Lower limb amputations: An increase in cases of lower limb amputation (primarily of the toe) has been observed in long-term clinical studies with another SGLT2 inhibitor. It is unknown whether this constitutes a class effect. Like for all diabetic patients it is important to counsel patients on routine prevention foot care.
Urine laboratory assessments: Due to its mechanism of action, patients taking Jardiance will test positive for glucose in their urine.
Lactose: The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Effect on ability to drive and use machines: Jardiance has minor influence on the ability to drive and use machines. Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Jardiance is used in combination with a sulphonylurea and/or insulin.
Use in patients with renal impairment: Renal function should be assessed prior to initiation of empagliflozin and regularly thereafter.
Monitoring of renal function is recommended prior to and following initiation of any concomitant drug which might have an impact on renal function.
Type 2 diabetes mellitus: The glucose-lowering benefits of empagliflozin decreases with declining renal function and was not demonstrated to be statistically significant in subjects with eGFR <30 ml/min/1.73 m² (see Table 8 under Pharmacology: Pharmacodynamics under Actions).
Use of empagliflozin is contraindicated in patients with eGFR < 30 ml/min/1.73 m².
In patients with an eGFR < 60 ml/min/1.73 m², more intensive monitoring of glycaemic and renal biomarker and signs and symptoms of renal dysfunction is recommended, especially if the eGFR is < 45 ml/min/1.73 m².
Discontinuation of empagliflozin is recommended if the eGFR falls to < 30 ml/min/1.73 m2 during treatment.Heart failure: Empagliflozin is not recommended for use in patients with eGFR <20 ml/min/1.73 m².
Use in the Elderly: The effect of empagliflozin on urinary glucose excretion is associated with osmotic diuresis, which could affect the hydration status. Patients aged 75 years and older may be at an increased risk of volume depletion. A higher number of these patients treated with empagliflozin had adverse reactions related to volume depletion as compared to placebo (see Adverse Reactions). Therefore, special attention should be given to their volume intake in case of co-administered medicinal products which may lead to volume depletion (e.g. diuretics, ACE inhibitors).