Summary of Use during Lactation

Information from one patient indicates that satralizumab was undetectable in milk and did not adversely affect the breastfed infant. Until more data become available, satralizumab 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.[1]

Drug Levels

Maternal Levels. A woman with neuromyelitis optica spectrum disorder received satralizumab 120 mg subcutaneously pregnancy and continued every 4 weeks during lactation. Two milk samples obtained at 19 and 26 days after 2 different doses contained undetectable (<0.2 mg/L) levels of satralizumab.[2]

Infant Levels. A woman with neuromyelitis optica spectrum disorder received satralizumab 120 mg subcutaneously pregnancy and continued every 4 weeks during breastfeeding. Two infant serum samples obtained at 19 and 26 days after 2 different doses contained undetectable (<0.2 mg/L) levels of satralizumab.[2]

Effects in Breastfed Infants

A woman with neuromyelitis optica spectrum disorder received satralizumab 120 mg subcutaneously pregnancy and continued every 4 weeks while breastfeeding. She was also receiving azathioprine 75 mg daily and oral prednisolone beginning at 20 mg daily and tapering to 8 mg daily. She breastfed her infant for 10 months. The infant remained healthy, with no serious infection and normal growth and development.[2]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1.

Krysko KM, Dobson R, Alroughani R, et al. Family planning considerations in people with multiple sclerosis. Lancet Neurol 2023;22:350-66. [PubMed: 36931808]

2.

Yoshida T, Watanabe O, Nomura M, et al. Neuromyelitis optica spectrum disorder safely and successfully treated with satralizumab during pregnancy and breastfeeding: A case report. Front Neurol 2023;14:1322412. [PMC free article: PMC10754991] [PubMed: 38162440]

Substance Name

Satralizumab

CAS Registry Number

1535963-91-7

Drug Class

Breast Feeding

Lactation

Milk, Human

Antibodies, Monoclonal, Humanized