Rabavert (purified chick embryo cell) Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned
Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-The ACIP has recommendations for use of rabies vaccine during pregnancy.
Animal studies have not been conducted. There are no controlled data in human pregnancy.
AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
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.
See references
Rabavert (purified chick embryo cell) Breastfeeding Warnings
Breastfeeding is not a contraindication for post-exposure prophylaxis
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-Nursing is not considered a contraindication for post-exposure prophylaxis because of the potential consequences of inadequately treated rabies.
-Pre-exposure prophylaxis may be indicated during nursing if the risk of rabies exposure is substantial.
See references