This sheet is about exposure to alirocumab in pregnancy and while breastfeeding. This information is based on published research studies. It should not take the place of medical care and advice from your healthcare providers.
What is alirocumab?
Alirocumab is a medication given by injection that is used to lower LDL (“bad”) cholesterol. LDL is called “bad” cholesterol because too much of it can build up in your blood vessels and increase your chance of heart disease and stroke. Alirocumab has been used to treat an inherited condition called familial hypercholesterolemia, which causes very high cholesterol. It has also been used in some people with heart or blood vessel disease to help lower the chance of heart attack and stroke. Praluent® is a brand name for alirocumab.
Sometimes when women find out they are pregnant, they think about changing how they take their medication, or stopping it 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 looking at 14 reports with some pregnancy exposure to alirocumab did not suggest an increase in the rate 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. We look at research studies to try to understand if an exposure, like alirocumab, might increase the chance of birth defects in a pregnancy.
Studies in animals have not found an increased risk of birth defects. There have been reports of pregnancies with and without birth defects after using alirocumab, but these reports do not show whether the medication caused the birth defects. Studies in pregnant women have not yet been done.
Based on what is known about similar medications, very little alirocumab is expected to cross the placenta during the first trimester, when many of the fetal organs and body structures are developing.
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 of pregnancy) or low birth weight (weighing less than 5 pounds, 8 ounces [2,500 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:
Studies have not been done on the use of alirocumab while breastfeeding. Because alirocumab is a large protein, only a small amount is expected to pass into breast milk. Any medication that does get into breast milk is also unlikely to be absorbed by the baby’s body because it is broken down in the baby’s digestive system. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a man 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 make healthy sperm) or increase the chance of birth defects. In general, exposures that men have are less likely 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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