Respiratory Drug (Monoclonal Antibody)
PREGNANCY RECOMMENDATION: No Human Data—No Relevant Animal Data
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of palivizumab in human pregnancy have been located. However, such reports are unlikely because the drug is indicated only for pediatric patients.
FETAL RISK SUMMARY
Palivizumab is a recombinant humanized monoclonal antibody antiviral that acts against respiratory syncytial virus (RSV). After IM injection, it acts by binding the RSV envelope fusion protein on the surface of the virus and blocking a critical step in the membrane fusion process. It also prevents cell-to-cell fusion of RSV-infected cells. Palivizumab is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk for RSV disease. In children <24 months of age, the mean half-life was 20 days (1).
Animal reproduction studies and studies for carcinogenicity, mutagenicity, and fertility have not been conducted (1).
It is not known if palivizumab crosses the human placenta. The molecular weight (about 148,000) suggests that it will not cross, at least in the 1st and 2nd trimesters.
BREASTFEEDING SUMMARY
No reports describing the use of palivizumab during human lactation have been located. Such reports are unlikely because the drug is indicated only for pediatric patients. Moreover, after the colostral phase, even if a lactating woman inadvertently received the drug, the high molecular weight (about 148,000) should prevent excretion of the monoclonal antibody into breast milk.
Reference
1.Product information. Synagis. MedImmune, 2012.