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) and polymyalgia rheumatica (PMR) when they have 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 also been used as an investigational drug in the treatment of people hospitalized with COVID-19 illness. A brand name for sarilumab is 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.
For more information about RA and pregnancy, please see our fact sheet at: https://mothertobaby.org/fact-sheets/rheumatoid-arthritis/.
I am taking sarilumab, but I would like to stop taking it before getting pregnant. How long does the drug stay in my body?
People eliminate medication at different rates. The time that it takes for this medication to leave the body depends upon the dose. In healthy adults, it can take 1 or 2 months, on average, for most of the sarilumab to be gone from the body.
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 makes 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 increases 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). Animal studies have suggested that sarilumab might delay the start of labor.
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.
Can my baby receive vaccines before one year of age if I take sarilumab later in pregnancy?
Since sarilumab may suppress the immune system of the person taking it, there is a theoretical concern that the same thing could happen to the baby if they are exposed during pregnancy. If someone has a weakened immune system they may be more likely to develop an infection from a live vaccine. Live vaccines contain a small amount of live virus. Inactivated vaccines do not contain live virus, so they cannot cause the disease they protect against. In the United States, rotavirus is the only live vaccine routinely given in the first year of life. Most people can get inactivated vaccines in the first year of life. Talk with your child’s healthcare provider about your exposure to sarilumab during pregnancy. They can talk with you about the vaccines your child should receive and the best time for your child to receive them.
Breastfeeding while taking sarilumab:
There is very little information on taking sarilumab during breastfeeding. One study looking at biologic medication in breastmilk included samples from 1 person on sarilumab; which found some sarilumab in breastmilk. Absorption into a nursing baby’s body is likely low for most babies because this medication is usually destroyed in the 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 or increase the chance of birth defects?
Studies have not been done to see if sarilumab could affect fertility (ability to get partner pregnant) 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/.
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.