This sheet is about exposure to mycophenolate 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 mycophenolate?
Mycophenolate is a medication that has been used to treat some autoimmune conditions like rheumatoid arthritis and lupus. Mycophenolate may also be taken to help prevent the body from rejecting an organ, such as a kidney, after a transplant. Mycophenolate works by lowering the immune system (the body’s defense system against substances and germs that could be harmful). Mycophenolate is sold under the brand name Cellcept®. A similar medication called mycophenolic acid is sold under the brand name Myfortic®.
For more information about rheumatoid arthritis and lupus, please see the MotherToBaby fact sheets at https://mothertobaby.org/fact-sheets/rheumatoid-arthritis/ and https://mothertobaby.org/fact-sheets/lupus-pregnancy/.
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 your 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 mycophenolate, 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. In healthy adults, it takes up to one week, on average, for most of the mycophenolate to be gone from the body.
I take mycophenolate. Can it make it harder for me to get pregnant?
It is not known if mycophenolate can make it harder to get pregnant.
The U.S. Food and Drug Administration (FDA) requires that people who may become pregnant participate in a mycophenolate education program before they start taking the medication. Healthcare providers who prescribe mycophenolate must also participate in the program. The program requires having a negative pregnancy test before starting mycophenolate and another negative pregnancy test eight to ten days after treatment begins. The program also recommends using effective birth control to prevent pregnancy while taking mycophenolate. Birth control should continue for 6 weeks after stopping mycophenolate. It is important to know that mycophenolate might make hormonal birth control methods, like birth control pills, not work as well to prevent pregnancy.
Does taking mycophenolate increase the chance for miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Taking mycophenolate in pregnancy can increase the chance of miscarriage. One report suggests the chance for miscarriage with mycophenolate use during pregnancy may be close to 50% (1 in every 2 pregnancies). Since some of the conditions that mycophenolate is used to treat can also increase the chance of miscarriage, it is hard to know if the medication, the medical condition, or other factors are the cause of a miscarriage.
Does taking mycophenolate 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. Taking mycophenolate during pregnancy might increase the chance of birth defects. A pattern of birth defects has been reported that includes unusually small or absent ears, eyes, and/or jaw; heart defects, cleft lip and/or palate (openings in the lip or the roof of the mouth), and others. Affected children might have only one birth defect or a combination of these birth defects. Not all children exposed to mycophenolate during pregnancy will have a birth defect.
Does taking mycophenolate in pregnancy increase the chance of other pregnancy-related problems?
It is not known if mycophenolate can cause other 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 mycophenolate in pregnancy affect future behavior or learning for the child?
It is not known if mycophenolate increases the chance for behavior or learning issues.
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, such as defects of the ears, eyes, jaw, heart, lip, and palate. Ultrasound 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 mycophenolate:
It is not clear how much mycophenolate gets into breast milk. Limited reports of infants that have been exposed to mycophenolate through breastmilk have not reported harmful effects. Be sure talk to your healthcare provider about all of your breastfeeding questions.
If a male takes mycophenolate, could it affect fertility or increase the chance of birth defects?
Studies have not been done to see if mycophenolate could affect male fertility (ability to get partner pregnant). Three studies looking at 356 infants born to males taking mycophenolate around the time of conception found no increase in birth defects. Another report including 255 children born to males taking mycophenolate also showed no increase in miscarriage or birth defects.
Due to theoretical concern (and not proven risks), some healthcare providers may recommend that males taking mycophenolate wait at least three months after stopping treatment before trying to conceive a pregnancy. 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 lupus and medications used to treat lupus in pregnancy. If you are interested in taking part in this study, please call 1-877-311-8972 or sign up at 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.
