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Mitoxantrone Pregnancy and Breastfeeding Warnings

Mitoxantrone is also known as: Novantrone

Mitoxantrone Pregnancy Warnings

Mitoxantrone has been assigned to pregnancy category D by the FDA. Animal data have revealed evidence of fetotoxicity (low fetal birth weight and retarded development of the fetal kidney) and premature delivery. There are no data from controlled human pregnancy studies. Use of mitoxantrone during pregnancy is considered contraindicated. Even if they are using birth control, women with multiple sclerosis who are biologically capable of becoming pregnant should have a pregnancy test (and the results should be known) before receiving each dose of mitoxantrone. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

A brief case in which a woman successfully delivered a healthy baby girl weighing 2,960 grams by Cesarean section at 34 weeks' gestation after consolidation therapy with mitoxantrone and cytarabine for acute promyelocytic leukemia has been reported.

Mitoxantrone Breastfeeding Warnings

In one case, a lactating woman, who had received mitoxantrone 6 mg/m2 once a day, a breast milk mitoxantrone concentration of 120 ng/mL was measured just after the end of the last mitoxantrone infusion. A breast milk mitoxantrone concentration of 18 ng/mL was still detectable 28 days after drug administration. These data suggest that this drug is distributed into and is slowly cleared from the mammary gland. The woman began to breast-feed her baby from 3 weeks after completion of mitoxantrone therapy. There were no abnormalities in the nursing infant during the 16 months after birth.

Mitoxantrone is excreted into human milk. In the only case report available, no adverse effects were observed in a nursing infant whose mother had received consolidation therapy for acute promyelocytic leukemia. Because of the unknown risk and the potential for serious adverse reactions in infants from mitoxantrone, breast-feeding should be discontinued before starting treatment.

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