Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation
Contraception in males and females

Mitoxantrone is genotoxic and is considered a potential human teratogen. Therefore men under therapy must be advised not to father a child and to use contraceptive measures during and at least 6 months after therapy. Women of childbearing potential must be advised to avoid becoming pregnant; should have a negative pregnancy test prior to each dose and use effective contraception during therapy and for at least 4 months after cessation of therapy.
Pregnancy

There are very limited data on the use of mitoxantrone in pregnant women. Mitoxantrone was not teratogenic in animal studies at doses below human exposure, but caused reproductive toxicity (see section 5.3). Mitoxantrone is considered a potential human teratogen because of its mechanism of action and the developmental effects demonstrated by related agents. For this reason, the use of mitoxantrone to treat MS is contraindicated for pregnant women (see section 4.3). When used for treatment in other indications mitoxantrone should not be administered during pregnancy in particular during the first trimester of pregnancy. In each individual case the benefit of treatment must be weighed up against the possible risk to the foetus. If this medicinal product is used during pregnancy or if the patient becomes pregnant while taking mitoxantrone, the patient should be informed of the potential risk to the foetus and genetic counselling should be provided.
Breast-feeding

Mitoxantrone is excreted in breast-milk and has been detected in breast-milk for up to one month after the last administration. Because of the potential for serious adverse reactions in infants from mitoxantrone, breast-feeding is contraindicated (see section 4.3) and must be discontinued before starting treatment.
Fertility

Women treated with Mitoxantrone have an increased risk of transitory or persistent amenorrhoea and therefore preservation of gametes should be considered prior to therapy. In men, no data are available, but tubular atrophy of the testes and reduced sperm counts were observed in animals (see section 5.3).