Bdfoie 4/Bdfoie 10 Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment with Lenvatinib and for at least one month after finishing treatment. It is currently unknown whether Lenvatinib may reduce the effectiveness of hormonal contraceptives, and therefore women using oral hormonal contraceptives should add a barrier method.
Pregnancy: There are no data on the use of Lenvatinib in pregnant women. Lenvatinib was embryotoxic and teratogenic when administered to rats and rabbits.
Lenvatinib should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the fetus.
Breastfeeding: It is not known whether Lenvatinib is excreted in human milk. Lenvatinib and its metabolites are excreted in rat milk. A risk to newborns or infants cannot be excluded and, therefore, Lenvatinib is contraindicated during breastfeeding.
Fertility: Effects in humans are unknown. However, testicular and ovarian toxicity has been observed in rats, dogs, and monkeys.