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, please see below and also refer to the manufacturer’s prescribing information for everolimus or pembrolizumab.

Fertility

Effects in humans are unknown. No specific studies with lenvatinib have been conducted in animals to evaluate the effect on fertility; however, results from general toxicology studies in rats, monkeys, and dogs suggest there is a potential for lenvatinib to impair fertility.

Pregnancy

There is insufficient information on the use of lenvatinib in pregnant women. Oral administration of lenvatinib during organogenesis at doses below the recommended human dose resulted in embryotoxicity and teratogenicity in 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. Women should avoid becoming pregnant and use effective contraception while on treatment with lenvatinib.

Lactation

It is not known whether lenvatinib is excreted in human milk. Lenvatinib and its metabolites are excreted in rat milk. A risk to newborn or infants cannot be excluded, and therefore lenvatinib should not be used during breastfeeding.