This sheet is about exposure to sarilumab in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare provider.
What is sarilumab?
Sarilumab is a medication that has been used for the treatment of rheumatoid arthritis (RA) that has not responded to other medications. Sarilumab is a monoclonal antibody (a protein made by the body’s immune system) that binds and blocks interleukin-6 (a protein that causes inflammation). It has recently been used as an investigational drug in the treatment of hospitalized patients with COVID-19 illness. Sarilumab has been sold under the brand name Kevzara®.
Sometimes when people find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take this medication. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.
I take sarilumab. Can it make it harder for me to get pregnant?
Studies have not been done in humans to see if taking sarilumab can make it harder to get pregnant. Animal studies do not suggest sarilumab could make it harder to get pregnant.
Does taking sarilumab increase the chance for miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Studies have not been done in humans to see if taking sarilumab during pregnancy could increase the chance for miscarriage. Animal studies do not suggest taking sarilumab could increase the chance for miscarriage.
Does taking sarilumab increase the chance of birth defects?
Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Studies have not been done in humans to see if sarilumab increases the chance for birth defects above the background risk. Animal studies do not suggest an increased chance of birth defects.
Does taking sarilumab in pregnancy increase the chance of other pregnancy-related problems?
It is not known if sarilumab increases the chance for pregnancy-related problems such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [about 2500 grams] at birth).
Does taking sarilumab in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if sarilumab can cause behavior or learning issues for the child.
Breastfeeding while taking sarilumab:
There are no studies looking at sarilumab during breastfeeding. Because sarilumab is a large protein, it is expected that the amounts that get into breast milk are small. Absorption by the baby is also less likely because the medication that reaches the baby through breastmilk is likely to be destroyed in the child’s gastrointestinal (GI) system. Be sure to talk to your healthcare provider about all of your breastfeeding questions.
If a male takes sarilumab, could it affect fertility (ability to get partner pregnant) or increase the chance of birth defects?
Studies have not been done to see if sarilumab could affect fertility or increase the chance of birth defects above the background risk. In general, exposures that fathers or sperm donors have are unlikely to increase the risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.
MotherToBaby is currently conducting a study looking at sarilumab and other medications used to treat autoimmune diseases in pregnancy. If you are interested in taking part in this study, please call 1-877-311-8972, or visit: https://mothertobaby.org/join-study/.
Please click here for references.
OTIS/MotherToBaby encourages inclusive and person-centered language. While our name still contains a reference to mothers, we are updating our resources with more inclusive terms. Use of the term mother or maternal refers to a person who is pregnant. Use of the term father or paternal refers to a person who contributes sperm.
