Luseco Adverse Reactions

Summary of the safety profile: In all the clinical trials of patients with Type 2 diabetes mellitus in Japan (TS071-02-1, TS071-02-3, TS071-03-1, TS071-03-2, TS071-03-3, TS071-03-4, TS071-03-5), adverse reactions including abnormal investigation findings were observed in 236 out of 1262 subjects (18.7%) administered at 2.5 mg dose (including at increased dose of 5 mg) of luseogliflozin. Major adverse reactions (adverse reactions observed in more than 2% of subjects) were pollakiuria (35 cases, 2.8%), hypoglycemia (30 cases, 2.4%), and β2 microglobulin urine increased (26 cases, 2.1%). Adverse reactions related to cardiovascular disorders were observed in 12 patients (1.0%) [At the time of approval in Japan].
Tabulated list of adverse reactions: The following adverse reactions have been reported in all the clinical trials and from post-marketing experience with Luseogliflozin (Luseco). Adverse reactions listed as follows are classified according to frequency and system organ class (SOC). Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). (See Table 11.)

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Clinically significant adverse reactions: Hypoglycemia: Hypoglycemia may occur in combined use with other antidiabetic drugs (in particular, sulfonylureas, insulin preparations or GLP-1 receptor agonists). In addition, hypoglycemia was reported without combined use of other antidiabetic drugs. When hypoglycemic symptoms are observed, appropriate measures such as eating food containing carbohydrates should be taken. However, when hypoglycemic symptoms are observed in combined use with α-glucosidase inhibitors, glucose should be administered (see Precautions, Interactions and Pharmacology: Pharmacodynamics under Actions).
Pyelonephritis, sepsis, necrotizing fasciitis of the perineum (Fournier's gangrene): Pyelonephritis may occur and may result to sepsis (including septic shock). Onset of Fournier's gangrene, rare but serious infection requiring urgent surgical intervention, has been reported in patients with diabetes mellitus receiving other sodium-glucose cotransporter 2 (SGLT2) inhibitors. Patients should be closely monitored. If any abnormality is noted, administration should be discontinued and appropriate treatment should be provided (see Precautions).
Dehydration: Dehydration may occur. Patients should be monitored sufficiently. When symptoms including thirst, polyuria, pollakiuria and blood pressure decreased appear and dehydration is suspected, appropriate measures including interruption of administration and fluid replacement should be taken. Since onset of thromboembolism such as cerebral infarction following dehydration has been reported, sufficient attention should be paid (see Precautions).
Ketoacidosis: Since ketoacidosis (including diabetic ketoacidosis) may occur, patients should be closely monitored. If any abnormality is noted, administration should be discontinued and appropriate treatment should be provided (see Precautions).