Sarilumab

The Basics

What is Sarilumab?

Indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Brand names for Sarilumab

Kevzara

How Sarilumab is classified

Antibodies – Monoclonal, Antirheumatic Agents

Sarilumab During Pregnancy

Sarilumab pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Sarilumab while pregnant

The limited human data with KEVZARA in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage. Monoclonal antibodies, such as sarilumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant [see Clinical Considerations]. From animal data, and consistent with the mechanism of action, levels of IgG, in response to antigen challenge, may be reduced in the fetus/infant of treated mothers [see Clinical Considerations and Data]. In an animal reproduction study, consisting of a combined embryo-fetal and pre-and postnatal development study with monkeys that received intravenous administration of sarilumab, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 84 times the maximum recommended human dose (MRHD) . The literature suggests that inhibition of IL-6 signaling may interfere with cervical ripening and dilatation and myometrial contractile activity leading to potential delays of parturition . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. KEVZARA should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Taking Sarilumab While Breastfeeding

What are recommendations for lactation if you're taking Sarilumab?

No information is available on the clinical use of sarilumab during breastfeeding. Because sarilumab is a large protein molecule with a molecular weight of about 150,000, 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. If sarilumab is required by the mother, it is not a reason to discontinue breastfeeding.[1] Until more data become available, sarilumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Sarilumab is a human immunoglobulin G1 (IgG1) antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G in mature milk by 60 to 79%.[2][3] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[4] None of the studies measured IgG activity.

Maternal / infant drug levels

No information is available on the clinical use of sarilumab during breastfeeding. Because sarilumab is a large protein molecule with a molecular weight of about 150,000, 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. If sarilumab is required by the mother, it is not a reason to discontinue breastfeeding.[1] Until more data become available, sarilumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Sarilumab is a human immunoglobulin G1 (IgG1) antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G in mature milk by 60 to 79%.[2][3] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[4] None of the studies measured IgG activity.

Possible effects of Sarilumab on milk supply

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

Possible alternatives to Sarilumab

Adalimumab, Certolizumab Pegol, Etanercept, Infliximab.