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Biologics in Breastmilk: What Are the Risks?

ASCPT Members-Only Webinar Presented by the Regulatory Science (RS) and Special Populations (SPO) Communities

Speakers: Philip Anderson, PharmD; and Shinya Ito, MD
Moderators: Elimika Pfuma Fletcher, PharmD, PhD; and Pooja Manchandani, PhD

Biologics have accounted for 50% or more of recent new drug approvals and are expected to be of growing importance. Breastfeeding is encouraged in women due to both benefits in infant health and maternal-fetal bond development. In the 2019 lactation guidance, US Food & Drug Administration articulated situations in which lactation studies will be required/should be considered for drugs. Drug concentrations in breastmilk have been reported for some biologics both in literature and drug labels. However, the interpretation of this information can be challenging as most of the estimates of infant exposure and clinical relevance have been established based on small molecules. This is further complicated by the expectation that biologics may have limited stability in the gastrointestinal tract and limited absorption.
Reports of FcRn in neonates that could enhance absorption of IgG monoclonal antibodies in neonates, increased pH in the neonatal period, and reports of proteins including milk peptides in infant fecal matter have raised questions about situations when one may worry about systemic absorption of biologics in infants. As more lactation studies are performed for biologics, it is important to consider the utility of these lactation studies and how the data can be interpreted to inform risk management in breastfeeding beyond reporting drug concentrations in breastmilk. This session will include thought leaders to discuss considerations for the use of biologics in lactating individuals and assessing risks to the breastfeeding infants.
Learning Objectives: 1. Approaches used to translate lactation data into understanding risk/challenges for biologics. 2. Factors that impact drug absorption in pediatrics. 3. Modelling approaches

Dec 7, 2022 12:00 PM in Eastern Time (US and Canada)