Is Sarilumab safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Sarilumab. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Because sarilumab is a large protein molecule with a molecular weight of about 150,000 Da, the amount in milk is likely to be very low.[1] It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[2] One infant was safely breastfed for 6 months after maternal sarilumab was resumed at 28 days postpartum. If sarilumab is required by the mother, it is not a reason to discontinue breastfeeding.[3] Until more data become available, sarilumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[4]
Effects on the breastfed infant
A woman with rheumatoid arthritis refractory to etanercept took sarilumab 200 mg every two weeks during pregnancy until 37 weeks of gestation. She was also taking prednisolone 10 mg and tacrolimus 3 mg daily. She delivered a healthy infant at 38 weeks of gestation and breastfed her infant. Prednisolone was continued postpartum; tacrolimus was restarted at 7 days postpartum and sarilumab was restarted at 28 days postpartum. The mother continued to breastfeed until 6 months postpartum. The infant was vaccinated with multiple live vaccines after reaching six months old, including the Bacille-Calmette-Guerin vaccine, with no adverse effects.[6]
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. A lactating woman was receiving subcutaneous sarilumab 150 mg every 2 weeks for rheumatoid arthritis. After 5 doses of the drug, she donated 6 milk samples over a 28-day period. The peak concentration of about 160 mcg/L occurred on day 3 after the dose. By day 7, the milk sarilumab concentration decreased to about 110 mcg/L; on day 14, the milk concentration was about 75 mcg/L. The drug was undetectable in mill at 28 days after the dose.[5]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Sarilumab” (LM1324). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.