Animal studies at doses of 80 to 160 mg/kg/day (80 mg/kg/day is over 4000 times a single dose on a mg/m2 basis) given during organogenesis caused significant fetal toxicity (increased fetal mortality, increased resorptions, late fetal death, fewer fetuses per litter, decreased fetal weight, and increased skeletal malformation), which was associated with significant maternal weight loss, anorexia, and increased relative liver weight. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

Safety has not been established during pregnancy.
This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: D

Comments:
-This drug may cause fetal harm if given to a pregnant woman.
-If used during pregnancy, or the patient becomes pregnant on this drug, advise the patient about the potential harm to the fetus.
-Both men and women are advised to take adequate contraceptive precautions until completion of therapy.
-Some products are US FDA pregnancy category C.

See references

Use is contraindicated. (UK)
Caution is recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (US)

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

See references