Animal reproductive or developmental toxicity studies were not conducted with this drug. The cytotoxic component disrupts microtubule function, is genotoxic, and can be toxic to rapidly dividing cells, suggesting it has the potential to cause embryotoxicity and teratogenicity. There are no controlled data in human pregnancy.

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 should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman, because it contains a genotoxic compound (the microtubule inhibitor, MMAF) and it targets actively dividing cells. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, this drug has the potential to be transmitted from the mother to the developing fetus.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.
-Advise women of reproductive potential to use effective contraception during treatment and for 4 months after.
-Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during therapy and for 6 months after.
-Based on findings in animal studies, this drug may impair fertility in females and males; the effects were not reversible in male rats but were reversible in female rats.

See references

Use should be avoided.

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

Comments:
-There are no data on the presence of this drug in human milk or the effects on the breastfed child or milk production.
-Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during therapy and for 3 months after.

See references