Use should be avoided.

US FDA pregnancy category: Not assigned

Comments:
-This drug may cause fetal harm if administered during pregnancy. Use an alternative treatment for smallpox in pregnant women.
-Pregnancy testing should be performed in women of childbearing potential before starting treatment with this drug.
-Women of childbearing potential should avoid becoming pregnant and should use effective contraception during treatment and for at least 2 months after the last dose.
-Males of reproductive potential with partners of childbearing potential should use condoms during treatment and for at least 4 months after the last dose.

In animal studies, the oral administration of this drug to pregnant rats and rabbits, resulted in embryotoxicity and structural malformations. The systemic exposure was less than the expected human exposure with the recommended dose of this drug. 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

See references

Use is not recommended.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-There is the potential for variola virus transmission through direct contact of the mother with the breastfed infant. Breastfeeding is not recommended in patients with smallpox.

See references