Use is not recommended unless clearly needed.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings in animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Administration to pregnant animals during organogenesis and through lactation caused fetal anomalies and abortions.

Comments:
-Adequate methods of contraception should be encouraged.
-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.

Animal studies revealed administration of this drug during organogenesis and through lactation led to offspring death within the first 4 days after birth. No treatment-related malformations were observed in animals, but alterations (left-sided umbilical artery, cervical rib) and early post-implantation losses occurred at maternally toxic doses. Precocious ossification was also observed in animals, independent of maternal toxicity or fetal body weight changes. There were no effects on mating or fertility in male and female animals at doses up to 8 times the expected human clinical exposure based on AUC; however, significant decreases in fetal body weights and in the number of live fetuses were observed at doses 3.3- and 6.4-times the expected human clinical exposure based on AUC. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

No information is available on the use of this drug during breastfeeding; however, the amount in breastmilk is likely to be low because it is more than 99% bound to plasma proteins. It might accumulate in the infant due to its half-life of 24 hours. It is also given in combination with capecitabine, which may increase the risk to the infant.

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for 1 week after.

See references