Odalade Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies of eltrombopag in pregnant women to inform a drug associated risk. In animal developmental and reproductive toxicology studies, oral administration of eltrombopag to pregnant rats and rabbits throughout organogenesis resulted in developmental toxicity in rats. The effect of eltrombopag on human pregnancy is unknown. Pregnant women or women of childbearing potential should be advised of the potential risk of eltrombopag to a fetus. Eltrombopag should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
Contraception: Based on animal reproduction studies, eltrombopag can cause fetal harm when administered to a pregnant woman. Sexually-active females of reproductive potential should use effective contraception (methods that result in less than 1% pregnancy rates) when using eltrombopag during treatment and for at least 7 days after stopping treatment with eltrombopag.
Lactation: There is no information regarding the presence of eltrombopag or its metabolites in human milk, or their effects on the breastfed infant, or on milk production. However, eltrombopag was detected in the pups of lactating rats 10 days postpartum suggesting the potential for transfer during lactation. A decision must be made whether to discontinue breastfeeding or to continue/abstain from eltrombopag therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.