This sheet is about exposure to copolymer 1 (glatiramer acetate; glatiramer) in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare providers.
What is copolymer 1?
Copolymer 1, also known as Cop-1, glatiramer acetate, or glatiramer, is a disease modifying therapy (DMT) used to treat relapsing-remitting multiple sclerosis (RRMS). For more information about multiple sclerosis (MS), please see the MotherToBaby fact sheet at https://mothertobaby.org/fact-sheets/multiple-sclerosis/. Copolymer 1 is given as an injection. It is sold under the brand name Copaxone®.
I take copolymer 1. Can it make it harder for me to get pregnant?
Copolymer 1 has not been studied to see if it could make it harder to get pregnant.
I just found out I am pregnant. Should I stop taking copolymer 1?
Talk with your healthcare provider before making any changes to how you take your medication. Your healthcare provider can talk with you about the risks and benefits of continuing or stopping copolymer 1 during pregnancy.
Does taking copolymer 1 increase the chance for miscarriage?
Miscarriage can occur in any pregnancy. Although there have been case reports of miscarriage among people who are pregnant and taking copolymer 1, there is no evidence of an increased chance for miscarriage compared to the general population or compared to people who are pregnant and have MS but are not taking copolymer 1.
Does taking copolymer 1 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. One study on over 5,000 pregnancies exposed to copolymer 1 did not show an increased chance of birth defects. Other studies have suggested possible increased chances of birth defects, with reports of heart defects, gastrointestinal tract defects, clubfoot, hip dysplasia, and limb abnormalities. However, since these studies did not identify a specific pattern of birth defects, these findings could have been due to chance or to other reasons.
Could taking copolymer 1 cause other pregnancy complications?
Pregnancy complications reported in people taking copolymer 1 include stillbirth, intrauterine death/fetal demise, ectopic pregnancy (a fertilized egg that implants outside of the uterus), and molar pregnancy (an abnormal growth inside the uterus that will not become a pregnancy). These outcomes were reported in less than 1 in 50 (less than 2%) of pregnancies exposed to copolymer 1.
Does taking copolymer 1 in pregnancy cause long-term problems in behavior or learning for the baby?
Information is limited about long-term effects on a baby from using copolymer 1 during pregnancy. One study used medical charts to examine the long-term development of children ages 1 to 39 years (average age 6 years) delivered by people with MS. Researchers did not find any differences in learning or motor development between those children exposed to certain DMT medications during pregnancy (39 with copolymer 1 exposure) and those who were not exposed to these medications.
Can I breastfeed while taking copolymer 1?
Copolymer 1 is not expected to pass into breast milk or enter the baby’s system if swallowed (although very young infants might absorb small amounts). Studies and reports of children whose parent used copolymer 1 while breastfeeding have not reported side effects or differences in the children’s development or their rates of illness compared to other children. If you are concerned about any symptoms that a baby has, contact the child’s healthcare provider.
I take copolymer 1. Can it make it harder for me to get my partner pregnant or increase the chance of birth defects?
Only a few studies have looked at pregnancy outcomes when a father is taking copolymer 1. The studies found no significant or clear evidence of an increased chance of low birthweight, miscarriage, birth defects, or other pregnancy concerns. 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/.
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OTIS/MotherToBaby recognizes that not all people identify as “men” or “women.” When using the term “mother,” we mean the source of the egg and/or uterus and by “father,” we mean the source of the sperm, regardless of the person’s gender identity.