This drug has been shown to be embryotoxic, teratogenic, mutagenic, and carcinogenic in animal studies. Animal studies showed an increased incidence of fetal abnormalities (e.g., parieto-occipital cranioschisis, umbilical hernias, rachischisis, abortions) at approximately 1/100 th of the highest recommended human dose and an increased incidence of esophageal, cardiovascular, and urogenital abnormalities as well as rib fusions at doses approximately 1/2 the recommended human dose. Decreases in fetal birth weight and post-delivery growth rate were also observed. There are no adequate and well-controlled studies in pregnant women.

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.

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-This drug has been shown to cross the placenta.
-This drug can harm a developing fetus.
-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 harm to the fetus.
-Women of childbearing potential should use effective contraception during therapy.
-Genetic counseling is recommended for women who want to become pregnant after completing therapy.
-This drug can induce chromosomal damage in human spermatozoa. Men should receive counseling on sperm conservation before start of therapy because of the possibility of irreversible infertility.
-Men taking this drug should use effective contraceptive methods during and up to 6 months after therapy.

See references

Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-It is unknown if this drug is excreted into human milk; however, other anthracyclines are excreted in breast milk.
-The effects in the nursing infant are unknown.

See references