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TS-ONE is contraindicated in patients who are or may be pregnant. It has been reported that pregnant women treated with tegafur/uracil have delivered neonates with malformation.
Teratogenicity is also reported in animal experiments. Consecutive oral administration of TS-ONE (corresponding to 7 mg/kg and 1.5 mg/kg as tegafur) to pregnant rats and rabbits has been observed to have fetal visceral anomalies, skeletal anomalies and retarded ossification.
When TS-ONE is administered to nursing mothers, breastfeeding should be discontinued. There is no clinical data. Excretion to milk has been reported in animal (rats) experiments.
