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General: Luseogliflozin (Luseco) should be used only in patients diagnosed with type 2 diabetes mellitus and should not be administered to patients with type 1 diabetes mellitus.
Use of Luseogliflozin (Luseco) should be considered only when diet and exercise therapies, which are the basis of treatment of diabetes mellitus, were thoroughly used, but were not sufficiently effective.
Use in patients with renal impairment: An increase in serum creatinine or a decrease in eGFR may be observed in the administration of Luseogliflozin (Luseco). Renal function should be checked periodically and in the treatment of patients with renal impairment, the course should be sufficiently monitored (see Dosage & Administration, and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Use in patients with hepatic impairment: There is no experience in the use for patients with severe liver dysfunction and safety in these patients has not been established (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Use in patients at risk for volume depletion: Luseogliflozin (Luseco) should be administered with care in patients who are likely to develop dehydration (patients whose plasma glucose is controlled extremely poorly, elderly patients, patients concomitantly using diuretics, etc.). [Diuretic effect of Luseogliflozin (Luseco) may lead to dehydration.]
Polyuria or pollakiuria may occur due to the diuretic action of Luseogliflozin (Luseco). Reduction of body fluid volume may occur. Patients should be monitored sufficiently. When abnormalities including dehydration and decrease in blood pressure occur, appropriate measures including interruption of administration and fluid replacement should be taken. Especially in patients who are likely to have hypovolemia (including elderly patients and patients with combined use of diuretics), attention should be paid to the onset of events including dehydration, diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, and thromboembolism such as cerebral infarction (see Dosage & Administration, Interactions and Adverse Reactions).
Urinary tract infections and genital infections: Luseogliflozin (Luseco) should be administered with care in patients with urinary tract infection or genital infection. [It may exacerbate the symptoms.]
Urinary tract infection and genital infection may occur and result in serious infections, such as pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene) and sepsis. Genital infection, such as vaginal candidiasis, may occur. Onset of urinary tract infection and genital infection should be checked with sufficient observations and other methods. When they occur, appropriate treatment should be provided and interruption of administration or other measures should be considered depending on the conditions (see Adverse Reactions).
Ketoacidosis: Due to the mechanism of action of Luseogliflozin (Luseco), i.e., enhancement of urinary glucose excretion, fatty acid metabolism may be enhanced, which may lead to ketosis and ultimately ketoacidosis, even when plasma glucose is well controlled. Since marked increase in blood glucose levels may not be observed in this course, patients should be carefully monitored for the following conditions (see Adverse Reactions).
When nausea/vomiting, decreased appetite, abdominal pain, severe thirst, malaise, dyspnea or disturbance of consciousness is present, tests, including blood or urine ketone tests, should be performed. If any abnormality is noted, administration should be discontinued and appropriate treatment should be provided. It should be known to patients that ketoacidosis can develop even if blood sugar levels increased are not found.
In particular, when impaired insulin secretion, dose reduction or discontinuation of insulin therapy, excessive carbohydrate intake restriction, poor food intake, infection, or dehydration is present, patients should be closely monitored because ketoacidosis is likely to occur.
Urine laboratory assessments: Due to the mechanism of action of Luseogliflozin (Luseco), urinary glucose becomes positive during its administration.
Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Luseogliflozin (Luseco).
Effects on ability to drive and use machines: Because hypoglycemic symptoms may occur, caution should be exercised in the administration to patients who work in high places, drive or use machines.
