Summary of Use during Lactation

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 and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[1] 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.[2] Until more data become available, sarilumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Drug Levels

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

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

Effects in Breastfed Infants

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.[3]

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

(Rheumatoid Arthritis) Adalimumab, Certolizumab Pegol, Etanercept, Infliximab, Tocilizumab

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.

Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75:795–810. [PubMed: 26888948]

3.

Mizutani S, Okunishi Y, Tamada T, et al. A woman with rheumatoid arthritis who successfully delivered a healthy child with continuous administration of sarilumab throughout pregnancy. Intern Med. 2023;62:633–6. [PMC free article: PMC10017234] [PubMed: 35871593]

Substance Name

Sarilumab

CAS Registry Number

1189541-98-7

Drug Class

Breast Feeding

Lactation

Milk, Human

Antibodies, Monoclonal

Antirheumatic Agents