Short answer: The labels differ. Praluent and Repatha say there is not enough human data to judge the risk, and animal studies showed no harm to development. Leqvio's label says to stop it when pregnancy is recognized, or to weigh the person's ongoing needs, because lowering cholesterol may harm a fetus. All three ask that pregnancies be reported. Plans for pregnancy are made with the prescriber.
| Praluent | Repatha | Leqvio | |
|---|---|---|---|
| Human pregnancy data | Not enough to judge risk | Not enough to judge risk | None available |
| Animal studies | No effects on development in rats; reduced immune response in infant monkeys | No effects on pregnancy or infant development in monkeys | No harmful effects on development in rats and rabbits |
| Label advice | Report pregnancies to a pregnancy safety study | Report pregnancies to the maker | Stop when pregnancy is recognized, or weigh ongoing needs; report to a pregnancy safety study |
| Breastfeeding | No information on milk; weigh benefits and risks | No information on milk; antibodies in milk are thought not to reach the baby's blood in large amounts | No information in people; found in rat milk |
Each label also notes the general background risk in the US: about 2% to 4% of recognized pregnancies have a major birth defect and 15% to 20% end in miscarriage, whatever medicines are taken.
The Leqvio label explains its advice by how the medicine works: it lowers cholesterol in the blood, and with it possibly other substances the body makes from cholesterol, so it may cause fetal harm. It also advises people who can become pregnant about the possible risk to a fetus and asks them to tell their prescriber about a known or suspected pregnancy so they can discuss stopping.
Leqvio is given only twice a year once started, and its LDL effect lasts for months after a dose. The label does not say how long before a planned pregnancy it should be stopped.
The Praluent and Repatha labels do not tell people to stop when pregnant. They say the data are too limited to show whether there is a risk, and the Patient Information for both says it is not known whether the medicine will harm an unborn baby. Both ask people to tell their healthcare provider if they become pregnant, and both makers collect reports: Praluent through a pregnancy safety study run by Regeneron, and Repatha through Amgen.
The Praluent label notes one animal finding: infant monkeys whose mothers were dosed during pregnancy had a weaker response to a test of the immune system. The label does not say what this means for people.
The labels approve these medicines for familial hypercholesterolemia, including in children (from age 8 for Praluent, 10 for Repatha and 12 for Leqvio), so pregnancy planning can come up. Whether to stop, pause or continue a cholesterol shot before or during pregnancy depends on the person's heart risk and the medicine, and is worked out with the prescriber and the pregnancy care team. Dose Track keeps a dated history of every injection, which helps when that team needs to know exactly when the last dose was given.
Read more on Dose Track: Leqvio dosing schedule · Praluent side effects · Repatha side effects · Leqvio vs Praluent