Skip to Content
How to talk to a doctor about advanced ovarian cancer >>

Mitoxantrone Pregnancy and Breastfeeding Warnings

Mitoxantrone is also known as: Novantrone

Mitoxantrone Pregnancy Warnings

UK: Use is contraindicated. AU and US: Use should be avoided. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -This drug can cause fetal harm when administered to a pregnant woman. -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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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

References for pregnancy information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):
  2. "Product Information. Novantrone (mitoxantrone)." Immunex Corporation, Seattle, WA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Novantrone (mitoxantrone)." Immunex Corporation, Seattle, WA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.