Pregnancy: Category D.
Cisplatin can cause fetal harm when administered to a pregnant woman. KEMOPLAT 1 mg/ml is mutagenic in bacteria and produces chromosome aberrations in animal cells in tissue culture. Safe use in pregnancy has not been established. In mice cisplatin is teratogenic and embryotoxic.
Lactation: After I.V. administration, KEMOPLAT 1 mg/ml is rapidly distributed into tissues including breast milk. To avoid possible harmful effects, it is recommended that KEMOPLAT therapy should not be initiated in lactating mothers.