Animal studies have revealed single intraperitoneal doses causing embryofetal lethality, increased fetal skeletal and visceral malformations, and decreased fetal body weights. Impaired spermatogenesis, azoospermia, and total germinal aplasia have been reported in males treated with alkylating agents, especially in combination with other drugs. Spermatogenesis may return in patients in remission, but only several years after intensive chemotherapy has been discontinued. 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.

Use is not recommended unless clearly needed.

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

Risk summary: : Based on animal data, this drug may cause fetal harm; animal studies have revealed evidence of embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth at doses 0.6 to 1.8 times the maximum recommended human dose.

Comments:
-Female patients should be advised to avoid becoming pregnant by using effective contraception before therapy, during treatment, and for at least 6 months after the last dose; male patients should be advised to use reliable contraception during and for at least 3 months after treatment.
-Pregnancy testing is recommended for females of reproductive potential prior to treatment.
-The possibility of irreversible infertility is associated with this drug; male patients should be warned of the potential risk to their reproductive capacities and advised to consider sperm conservation prior to treatment.

See references

Use is not 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.
-According to some authorities: Use is contraindicated.

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

Comments:
-The effects in the nursing infant are unknown.
-Advise females not to breastfeed during treatment and for at least 1 week after the final dose.

See references