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General: Forxiga should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Renal impairment: Treatment of diabetes mellitus: The glycaemic efficacy of dapagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and is likely absent in patients with severe renal impairment (see Dosage & Administration, Pharmacology: Pharmacodynamics and Pharmacology: Pharmacokinetics under Actions). In subjects with moderate renal impairment (GFR< 60 mL/min), a higher proportion of subjects treated with dapagliflozin had adverse reactions of increase in creatinine, phosphorus, parathyroid hormone (PTH) and hypotension, compared with placebo.
To improve glycaemic control in the treatment of diabetes mellitus. Forxiga should not be initiated in patients with a GFR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min. Forxiga has not been studied for glycaemic control in patients with severe renal impairment (GFR < 30 mL/min) or end stage renal disease (ESRD).
Monitoring of renal function is recommended as follows: Prior to initiation of dapagliflozin and at least yearly, thereafter (see Dosage & Administration, Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacology: Pharmacokinetics under Actions); Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter; For renal function with GFR < 60 mL/min, at least 2 to 4 times per year.
Chronic kidney disease: There is no experience with dapagliflozin for the treatment of chronic kidney disease in patients without diabetes who do not have albuminuria.
Type 1 diabetes mellitus: Dapagliflozin has not been studied for the treatment of heart failure in patients with type 1 diabetes mellitus. Treatment of these patients with dapagliflozin is not recommended.
Treatment of heart failure: There is limited experience with dapagliflozin for the treatment of heart failure in patients with severe renal impairment (GFR < 30 mL/min).
Ketoacidosis: There have been reports of ketoacidosis (DKA), including diabetic ketoacidosis, in patients with type 2 diabetes mellitus taking Forxiga and other SGLT2 inhibitors. Forxiga is not indicated for the treatment of patients with type 1 diabetes mellitus.
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.
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.
Urinary tract infections: Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therefore, temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis.
Use in patients with hepatic impairment: There is limited experience in clinical trials in patients with hepatic impairment. Dapagliflozin exposure is increased in patients with severe hepatic impairment (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Use in patients at risk for volume depletion and/or hypotension: 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), which 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.
For patients receiving dapagliflozin, 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 electrolytes) is recommended. Temporary interruption of treatment with dapagliflozin is recommended for patients who develop volume depletion until the depletion is corrected (see Adverse Reactions).
Cardiac failure: Experience with dapagliflozin in NYHA class IV is limited.
Chronic kidney disease: There is no experience with dapagliflozin for the treatment of chronic kidney disease in patients without diabetes who do not have albuminuria.
Elevated haematocrit: Haematocrit increase was observed with dapagliflozin treatment (see Adverse Reactions); therefore, caution in patients with already elevated haematocrit is warranted.
Combinations not studied: Dapagliflozin has not been studied in combination with glucagon-like peptide 1 (GLP-1) analogues.
Urine laboratory assessments: Due to its mechanism of action, patients taking Forxiga will test positive for glucose in their urine.
Lactose: The tablets contain lactose anhydrous. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Use in patients with diabetes and cardiovascular disease: In two 24-week, placebo-controlled studies with 80-week extension periods, a total of 1887 patients with type 2 diabetes and cardiovascular disease (CVD) were treated with dapagliflozin 10 mg or placebo. Patients with established CVD and inadequate glycemic control (HbA1c ≥7.0% and ≤10.0%), despite pre-existing, stable treatment with oral antidiabetic therapy (OADs) or insulin (alone or in combination) prior to entry, were eligible for these studies and were stratified according to age (<65 years or 65 years), insulin use (no or yes), and time from most recent qualifying cardiovascular event (>1 year or <1 year prior to enrollment). Across the 2 studies, 942 patients were treated with dapagliflozin 10 mg and 945 with placebo. Ninety-six percent (96%) of patients treated with dapagliflozin across the 2 studies had hypertension at entry, the majority for more than 10 years duration; the most common qualifying cardiovascular events were coronary heart disease (75%) or stroke (22%). Approximately 19% of patients received loop diuretics at entry and 15% had congestive heart failure (2% had NYHA Class III). Approximately 37% of patients treated with dapagliflozin 10 mg also received metformin plus one additional OAD at entry, (sulfonylurea, thiazolidinedione, DPP4-inhibitor, or other OAD with or without insulin at entry) 38% received insulin plus at least one OAD, and 18% received insulin alone.
Treatment with dapagliflozin 10 mg as add-on to pre-existing antidiabetic treatments over 24 weeks provided significant improvement in coprimary endpoints of HbA1c and composite clinical benefit compared with placebo in this population. Significant reductions in total body weight and seated systolic blood pressure were also seen. These benefits extended up to 104 weeks of treatment. The safety profile of dapagliflozin in these studies was consistent with that of dapagliflozin in the general clinical study population through 104 weeks of treatment.
Effects on ability to drive and use machines: Forxiga has no or negligible influence on the ability to drive and use machines. Patients should be alerted to the risk of hypoglycaemia when dapagliflozin is used in combination with a sulphonylurea.
Use in the Elderly: Elderly patients may be at a greater risk for volume depletion and are more likely to be treated with diuretics.
Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB). The same recommendations for renal function apply to elderly patients as to all patients (see Dosage & Administration, Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
