Lusefi Use In Pregnancy & Lactation

In pregnant women or women who may possibly be pregnant, Lusefi should not be administered and other drugs including insulin preparations should be used. [Safety for use during pregnancy has not been established. In animal studies (rats) of luseogliflozin, skeletal variations, delayed ossification, or membranous ventricular septum defect which were considered to be caused by a decrease in body weight of dams were observed in the oral administration at a dose of 150 mg/kg/day (equivalent to approximately 47 times the exposure (AUC) at the maximum recommended clinical dose (once daily administration of 5 mg)) or higher doses to pregnant animals. In animal studies (rats) of similar drugs, exposure of juvenile animals in the period corresponding to the mid to late pregnancy in humans was reported to cause dilatation of renal pelvis and renal tubule. In addition, transfer to fetuses was reported in animal studies (rats) of luseogliflozin).
Nursing women should be recommended to avoid breastfeeding during the administration of this drug. [In animal studies (rats), secretion into breast milk was observed].