Pregnancy & Lactation

Pregnancy & Fertility

Pregnancy

There is no information on the use of eribulin mesilate in pregnant women. Eribulin is embryotoxic, fetotoxic, and teratogenic in rats. Eribulin mesilate (Halaven) 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 of childbearing age must be advised to avoid becoming pregnant whilst they or their male partner are receiving Eribulin mesilate (Halaven) and should use effective contraception during and up to 3 months after treatment.

Fertility

Testicular toxicity has been observed in rats and dogs. Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Eribulin mesylate (Halaven).


Lactation

There is no information on the excretion of eribulin or its metabolites in human or animal breast milk. A risk to newborns or infants cannot be excluded and therefore Eribulin mesilate (Halaven) must not be used during breastfeeding.