Mitoxantrone Pregnancy and Breastfeeding Warnings

Brand names: Novantrone

Medically reviewed by Drugs.com. Last updated on Apr 7, 2025.

Mitoxantrone Pregnancy Warnings

Use should be avoided.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Based on the mechanism of action, this drug may cause fetal harm when administered to a pregnant woman. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-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.
-Women with who are capable of becoming pregnant, even if they are using birth control, should have a pregnancy test, before receiving each dose of this drug.
-Women of childbearing potential should be advised to avoid becoming pregnant.
-During therapy and for at least 6 months after termination of therapy, effective contraception should be practiced by patients of reproductive age, of either sex.

This drug is considered a potential human teratogen because of its mechanism of action and the developmental effects demonstrated by related agents. Studies in animals during the organogenesis period of gestation were associated with fetal growth retardation and an increased incidence of premature delivery at doses 0.01 times the recommended human dose on a mg/m2 basis. No teratogenic effects were observed in these studies, but the maximum doses tested were well below the recommended human dose. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Mitoxantrone Breastfeeding Warnings

UK: Use is contraindicated.
AU and US: Use should be avoided.

Excreted into human milk: Yes

Comments:
-This drug is excreted in human milk and significant concentrations have been reported for up to 28 days after the last administration.
-Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence, but the duration of abstinence is not clear.
-The effects in the nursing infant are unknown.

See references

Further information

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