Dapagliflozin exposure is increased in patients with severe hepatic impairment (see sections 4.2 and 5.2). There is limited experience in clinical studies in patients with hepatic impairment. In patients with moderate renal impairment (eGFR < 60 mL/min/1.73m 2), a higher proportion of patients treated with dapagliflozin had adverse reactions of increase in parathyroid hormone (PTH) and hypotension, compared with placebo. The glucose lowering efficacy of dapagliflozin is dependent on renal function, and is reduced in patients with eGFR < 45 mL/min/1.73m 2 and is likely absent in patients with severe renal impairment (see sections 4.2, 5.1 and 5.2). Therefore, it is not recommended to initiate treatment with dapagliflozin in patients with eGFR < 15 mL/min/1.73m 2 (see section 4.2). There is limited experience with initiating treatment with dapagliflozin in patients with eGFR < 25 mL/min/1.73m 2, and no experience with initiating treatment in patients with eGFR < 15 mL/min/1.73m 2. No data are available.įorxiga can be taken orally once daily at any time of day with or without food. The safety and efficacy of dapagliflozin for the treatment of heart failure or for the treatment of chronic kidney disease in children < 18 years have not yet been established. No data are available for children below 10 years of age. No dose adjustment is required for the treatment of type 2 diabetes mellitus in children aged 10 years and above (see sections 5.1 and 5.2). No dose adjustment is recommended based on age. If well tolerated, the dose may be increased to 10 mg (see sections 4.4 and 5.2). In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. No dose adjustment is necessary for patients with mild or moderate hepatic impairment. Therefore, if eGFR falls below 45 mL/min/1.73m 2, additional glucose lowering treatment should be considered in patients with type 2 diabetes mellitus (see sections 4.4, 4.8, 5.1 and 5.2). In patients with type 2 diabetes mellitus, the glucose lowering efficacy of dapagliflozin is reduced when eGFR is < 45 mL/min/1.73m 2, and is likely absent in patients with severe renal impairment. It is not recommended to initiate treatment with dapagliflozin in patients with an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m 2. No dose adjustment is required based on renal function.
When dapagliflozin is used in combination with insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8). The recommended dose is 10 mg dapagliflozin once daily.
0 kommentar(er)
