Is Nipocalimab safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Nipocalimab. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
Five infants were exposed to nipocalimab during pregnancy and postpartum in breastmilk. Their serum IgG levels decreased to nadir concentrations between 4 and 24 weeks after birth similar to the normal process of maternal IgG clearance in infancy, which is typically completed by approximately 24 weeks after birth and followed by endogenous IgG production. Infant vaccine responses that achieved protective titers to tetanus and diphtheria were observed in response to routine infant immunizations, except for one subthreshold diphtheria titer at 96 weeks after birth ( 20 months after the last vaccination).[ 2 ]
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. Thirteen pregnant participants delivered 12 live-born infants and one stillborn, a fetal loss due to intrauterine transfusion. Treatment was administered weekly from 14 to 35 weeks gestation. The dosage was initiated at 30 mg/kg baseline weight but was subsequently increased to 45 mg/kg. It was then modified again to 45 mg/kg of maternal weight assessed every 2 weeks. All 12 maternal participants had colostrum sampled between 0 and 3 days after birth and/or for breastmilk between 6 and 8 days after birth. All samples with detectable nipocalimab were collected from mothers who discontinued treatment less than 3 weeks before delivery (n = 5), whereas no nipocalimab was observed in colostrum or breastmilk from women who discontinued treatment more than 7 weeks before delivery (n = 7). Nipocalimab was detected in four of seven (57%) colostrum samples and two of nine (22%) breastmilk samples. In the four colostrum samples with detectable nipocalimab, 3 had concentrations less than 4 mg/L, below the threshold of 10 mg/L considered to be pharmacologically active, and 1 had a concentration of 68.4 mg/L. All breastmilk samples with detectable nipocalimab (n = 2) had concentrations less than 4 mg/L, When comparing colostrum with breastmilk samples across four maternal participants with both available colostrum and breastmilk samples, two showed low, pharmacologically inactive drug concentrations (1.35 and 3.66 mg/L) in colostrum and undetectable concentrations ( 0.01 mg/L ) in breastmilk. One maternal participant had an undetectable drug concentration in colostrum, but a low drug concentration (1.27 mg/L) in breastmilk. Another mother had a drug concentration of 68.4 mg/L in colostrum 2 days after delivery and 0.58 mg/L in breastmilk 8 days after delivery. This mother delivered on the day of the last nipocalimab administration and had a serum nipocalimab concentration of 1100 mg/L at delivery.[ 2 ] Infant Levels. Twelve mothers received nipocalimab initiated
Source: NIH LactMed (National Library of Medicine).
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.