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Mitoxantrone must not be used during pregnancy and lactation.
There are no adequate data from the use of mitoxantrone in pregnant women.
If mitoxantrone is used during pregnancy, or if the patient becomes pregnant during treatment with mitoxantrone, medical consultation about the risk of damaging effects to the embryo associated with the treatment should occur.
The effects of mitoxantrone can damage the genotype and influence the development of the embryo (see Precautions).
It is unknown if mitoxantrone can cross the placental barrier.
Breastfeeding should be discontinued before starting treatment with mitoxantrone. Mitoxantrone passes into breast milk and may be harmful to the child.
In animal studies, mitoxantrone showed no teratogenic or embryotoxic effects, however, it is considered to be potentially teratogenous in humans, due to its mechanism of action by DNA intercalation.
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