Lenvima Use In Pregnancy & Lactation

Information on fertility, pregnancy and lactation below is relevant to use of lenvatinib monotherapy. When using lenvatinib in combination with everolimus or pembrolizumab, see as follows and also refer to the manufacturer's prescribing information for everolimus or pembrolizumab.
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 (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Lenvatinib should not be used during pregnancy unless clearly necessary, and only after a careful consideration of the needs of the mother and the risk to the foetus.
Breastfeeding: It is not known whether lenvatinib is excreted in human milk. Lenvatinib and its metabolites are excreted in rat milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to newborns or infants cannot be excluded and, therefore, lenvatinib is contraindicated during breastfeeding (see Contraindications).
Fertility: Effects in humans are unknown. However, testicular and ovarian toxicity has been observed in rats, dogs, and monkeys (see Pharmacology: Toxicology: Preclinical safety data under Actions).