Actimmune Pregnancy Warnings
This drug has shown an increased incidence of abortions in primates when given from gestation day 20 to 80 in doses approximately 100 times the human dose. For lower doses, there is no evidence of maternal toxicity, embryotoxicity, fetotoxicity, or teratogenicity in animal studies. 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.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain 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.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.
Risk Summary: Animal studies at comparative human doses showed no evidence of maternal toxicity, embryotoxicity, fetotoxicity, or teratogenicity.
Comments:
-Based on the information available, it cannot be excluded that the presence of higher levels of interferon gamma may impair male and female fertility.
See references
Actimmune Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
Interferon gamma is a normal component of human milk. No data are available on the use of exogenous interferon gamma 1b during breastfeeding; however, the amounts of the similar drugs, interferon alfa and interferon beta-1a, excreted into milk are very low. Any interferon in breastmilk is probably destroyed in the infant GI tract and not absorbed, except perhaps in neonates.
See references
