This sheet is about exposure to evolocumab in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare provider.
What is evolocumab?
Evolocumab is a prescription medication that has been used to lower the levels of low-density lipoprotein (LDL) cholesterol. It has been used to treat a type of inherited high cholesterol called familial hypercholesterolemia (FH) and a type of heart disease called atherosclerotic cardiovascular disease (ASCVD). Evolocumab is made up of an antibody (blood protein), so it is called a biologic medication. It is sold under the brand name Repatha®.
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 high cholesterol in pregnancy, please see our fact sheet at https://mothertobaby.org/fact-sheets/high-cholesterol/.
I am taking evolocumab, 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 12 weeks (or 3 months), on average, for most of the evolocumab to be gone from the body.
I take evolocumab. Can it make it harder for me to get pregnant?
It is not known if evolocumab can make it harder to get pregnant.
Does taking evolocumab increase the chance for miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Studies have not been done to see if evolocumab increases the chance for miscarriage.
Does taking evolocumab 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 evolocumab increases the chance of birth defects. Based on what is known about other antibody medications, very little of the medication would be expected to reach the developing pregnancy in the first trimester.
Information from animal studies done by the manufacturer does not suggest that taking evolocumab in pregnancy increases the chance of birth defects.
Does taking evolocumab in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if evolocumab 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 evolocumab in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if evolocumab can cause behavior or learning issues for the child.
Breastfeeding while taking evolocumab:
Evolocumab has not been studied for use during breastfeeding. Because it is a very large protein, it is not likely that much of the medication would pass into breast milk. Evolocumab is not well absorbed by the stomach, so any medication that passes into breast milk would be unlikely to enter the baby’s blood system. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a male takes evolocumab, could it affect fertility (ability to get partner pregnant) or increase the chance of birth defects?
Studies have not been done in humans to see if evolocumab could affect male 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/.
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.
