Pregnancy: There is no information on the use of HALAVEN in pregnant women. Eribulin is embryotoxic, foetotoxic, and teratogenic in rats. 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 foetus.
Women of childbearing potential must be advised to avoid becoming pregnant whilst they are receiving HALAVEN and must use highly effective contraception during treatment with HALAVEN and for 7 months after treatment.
Men with partners of child-bearing potential should be advised not to father a child while receiving HALAVEN and must use effective contraception during HALAVEN treatment and for 4 months after treatment.
Breastfeeding: There is insufficient information on the excretion of eribulin or its metabolites in human or animal breast milk. A risk to newborn or infants cannot be excluded and therefore HALAVEN should not be used during breast feeding (see Contraindications).
Fertility: Testicular toxicity has been revealed in rats and dogs (see Pharmacology: Toxicology: Preclinical safety data under Actions). Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with HALAVEN.