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Topotecan Pregnancy and Breastfeeding Warnings

Topotecan is also known as: Hycamtin

Medically reviewed by Last updated on Apr 15, 2020.

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

-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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.