Animal studies have revealed evidence of abortifacient effect in rhesus monkeys given interferon alfa-n3 during the early phase of gestation at doses 360 times the maximum recommended dose. 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.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk Summary: Changes in menstrual cycle and abortions occurred in non-human primates given extremely high doses of this drug (360 times the maximum recommended dose).

Comments:
-Adequate methods of contraception should be encouraged.

See references

Because of the low levels in milk and poor oral absorption by the infant, it is unlikely that use by a nursing mother presents any serious risk to the breastfed infant.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.

See references