This sheet is about exposure to siponimod in pregnancy and while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.
What is siponimod?
Siponimod (Mayzent®) is a medication approved to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. To learn more about multiple sclerosis, please see our fact sheet at: https://mothertobaby.org/fact-sheets/multiple-sclerosis/.
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 am taking siponimod, but I would like to stop taking it before getting pregnant. How long does the drug stay in my body?
The time it takes the body to metabolize (to process) medication is not the same for everyone. In healthy non-pregnant adults, it takes up to 8 to 10 days, on average, for most of siponimod to be gone from the body.
I take siponimod. Can it make it harder for me to get pregnant?
Studies have not been done to see if siponimod can make it harder to get pregnant.
Does taking siponimod increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. According to the product label, experimental animal studies reported an increase in pregnancy loss. Studies have not been done in humans to see if siponimod increases the chance for miscarriage.
Does taking siponimod 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. According to the product label, experimental animal studies reported an increased chance for birth defects. Studies have not been done in humans to see if siponimod increases the chance for birth defects above the background risk.
Does taking siponimod in pregnancy increase the chance of other pregnancy-related problems?
According to the product label, experimental animal studies reported a chance of low birth weight. Studies have not been done in human pregnancy to see if siponimod 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 [2500 grams] at birth).
Does taking siponimod in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if siponimod can cause behavior or learning issues for the child.
What screenings or tests are available to see if my pregnancy has birth defects or other issues?
Prenatal ultrasounds can be used to screen for some birth defects. Ultrasounds can also be used to monitor the growth of the pregnancy. Talk with your healthcare provider about any prenatal screenings or testing that are available to you. There are no tests available during pregnancy that can tell how much effect there could be on future behavior or learning.
Breastfeeding while taking siponimod:
Siponimod has not been studied for use while breastfeeding. It is possible that small amounts of this medication might get into the breastmilk. However, these amounts can be potentially toxic for a breastfed infant. If you are taking siponimod while breastfeeding and you suspect the baby has any symptoms, such as vomiting, contact the child’s healthcare provider. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a male takes siponimod, could it affect fertility or increase the chance of birth defects?
Studies have not been done to see if siponimod could affect male 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/.
MotherToBaby is currently conducting a study looking at multiple sclerosis and medications used to treat it in pregnancy. If you would like to learn more about this study, please call 1-877-311-8972 or visit https://mothertobaby.org/join-study/.
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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.
