Skip to Content

Topotecan Pregnancy and Breastfeeding Warnings

Topotecan is also known as: Hycamtin

Topotecan Pregnancy Warnings

Use is contraindicated. (AU) The manufacturer makes no recommendation regarding use during pregnancy. (UK, US) AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -If the patient is pregnant or becomes pregnant during therapy, they should be advised of the potential hazards to the fetus. -Women of childbearing potential should use highly effective contraception during and for at least one month after treatment; males should use contraception during and for 3 months after treatment.

This drug caused embryolethality, fetotoxicity, and teratogenicity in animal models; embryo-fetal toxicity occurred at doses less than clinical doses in humans. Teratogenic effects included effects on the eye, brain, skull, and vertebrae. 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

Topotecan Breastfeeding Warnings

Contraindicated (AU, UK) A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. (US) Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: There is a potential for serious adverse reactions in nursing infants.

Animal models excreted this drug into milk at concentrations up to 48 fold higher than those in plasma.

See references

References for pregnancy information

  1. "Product Information. Hycamtin (topotecan)." SmithKline Beecham, Philadelphia, PA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Hycamtin (topotecan)." SmithKline Beecham, Philadelphia, PA.

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.