Use should be avoided.

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

Risk summary: Based on its mechanism of action, this drug can cause teratogenicity and/or embryofetal lethality when administered to a pregnant woman; no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-This drug contains a genotoxic component (SN-38) and is toxic to rapidly dividing cells.
-Pregnancy status of patients of childbearing potential should be verified prior to initiating therapy.
-This drug can cause fetal harm when administered to a pregnant woman; 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.
-Females of childbearing potential should be advised to use effective contraception during therapy and for 6 months after the last dose; because of the potential for genotoxicity, male patients with female partners of childbearing potential should be advised to use effective contraception during therapy and for 3 months after the last dose.
---Local protocol should be consulted regarding contraception timing.
-Based on findings in animals, this drug may impair fertility in females of childbearing potential.

Animal studies have not been reported; there were no reproductive and developmental toxicology studies conducted with this drug. 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 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

Breastfeeding is not recommended during use of this drug and for 1 month after the last dose.

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

Comments:
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions in a breastfed child.

See references