This sheet is about exposure to alirocumab 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 alirocumab?
Alirocumab is a medication that has been used to lower levels of low-density lipoprotein (LDL) cholesterol. It has been used to treat a specific type of inherited high cholesterol called familial hypercholesterolemia (FH) and for people with atherosclerotic cardiovascular disease (ASCVD). A brand name for alirocumab is Praluent®.
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. For more information about high cholesterol in pregnancy, please see our fact sheet at https://mothertobaby.org/fact-sheets/high-cholesterol/.
I take alirocumab. Can it make it harder for me to get pregnant?
Studies have not been done to see if alirocumab can make it harder to get pregnant.
Does taking alirocumab increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Data from one study suggests alirocumab is not expected to increase the chance of miscarriage.
Does taking alirocumab increase the chance of birth defects?
Birth defects can happen in any pregnancy for different reasons. Out of all babies born each year, about 3 out of 100 (3%) will have a birth defect. Data from animal studies does not suggest that alirocumab can increase the chance of birth defects.
Studies have not been done in humans to see if alirocumab can increase the chance of birth defects. There is one report of a person who took alirocumab along with two other medications until the 6th week of pregnancy and gave birth to a baby with absence of the corpus callosum (where the nerves connecting the two sides of the brain are missing). The authors stated it is unlikely that the use of alirocumab caused this condition.
Very little alirocumab is expected to cross the placenta and reach the developing pregnancy during the first trimester (when many of the fetal organs and body structures are forming). More of the medication can cross the placenta starting in the second trimester.
Does taking alirocumab in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if alirocumab can increase the chance of 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 alirocumab in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if alirocumab can increase the chance of behavior or learning issues for the child.
Breastfeeding while taking alirocumab:
Alirocumab is a large protein and little of the medication is expected to pass into breast milk. Alirocumab is not well absorbed from the intestines (gut) when swallowed so any medication that would get into breast milk is unlikely to enter the baby’s bloodstream. If you suspect the baby has any symptoms (such as fever or frequent infections), contact the child’s healthcare provider. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a male takes alirocumab, could it affect fertility or increase the chance of birth defects?
Studies have not been done to see if alirocumab could affect male fertility (ability to get partner pregnant) or increase the chance of birth defects. Having high cholesterol might lower the ability to get a partner pregnant. In general, exposures that fathers or sperm donors have are unlikely to increase 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 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.
