Bexsero (menb) Pregnancy Warnings
Use is not recommended unless clearly needed.
AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned
Comments:
-Vaccination should not be withheld when there is a clear risk of meningococcal exposure.
Animal studies did not show impaired fertility or harm to the fetus. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.
To monitor the outcomes of pregnant women exposed to Bexsero(R), a pregnancy registry has been established in the US. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-683-4732.
AU TGA pregnancy category B1: 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 not shown 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
Bexsero (menb) Breastfeeding Warnings
Animal studies did not show adverse reactions in mothers or offspring through day 29 of lactation; immunogenicity was seen in mothers vaccinated prior to lactation, and antibodies were detected in the offspring, but antibody levels in milk were not determined.
Benefit should outweigh risk.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
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.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
See references
