Since the U.S. FDA’s approval of TrikaftaTM (elexacaftor/tezacaftor/ivacaftor) in 2019, we have seen a dramatic increase in lung function, general health and quality of life for people living with cystic fibrosis. As a result, more women with CF are becoming pregnant. This raises questions regarding the use and impact of Trikafta during pregnancy.

How does Trikafta impact fertility?

Currently, it is unclear how Trikafta acts on the reproductive system to improve fertility. It is believed that Trikafta changes the mucus in the cervix and uterus making its environment more suitable for pregnancy. Trikafta also improves other aspects of health, such as lung function and nutrition, making it easier to become pregnant. Since Trikafta may impact fertility in women, it is important to consider family planning and birth control if you are on this medication. If you do not wish to become pregnant, effective birth control (such as the birth control pill or a hormonal IUD) should be used. Talk to your CF team if you are considering pregnancy to get up-to-date information.

Can Trikafta be used during pregnancy and lactation?

Currently, as Trikafta has only been available for a few years, there are very few studies of Trikafta in pregnant women so the effect of this drug on a developing fetus is unclear. However, we do have more experience with other CFTR modulator drugs such as Kalydeco (ivacaftor), Orkambi (lumacaftor/ivacaftor) and Symdeko (tezacaftor/ivacaftor) and it appears that these medications are generally safe in pregnancy.   Trikafta is transferred across the placenta to the baby and Trikafta is also present in breast milk.  A recent study looked at outcomes in 47 women on Trikafta during pregnancy and breastfeeding and found no serious negative effect on the infants and the miscarriage rate was consistent with the general population. The authors concluded that the use of Trikafta during pregnancy and breastfeeding showed no alarming safety concerns.

Although there is limited information on the safety of Trikafta during pregnancy and lactation, many women choose to remain on Trikafta while pregnant to help maintain their health. In some cases, the discontinuation of Trikafta led to a decline in the health of the woman which can adversely impact the fetus. It is important to work with your CF care team to assess the risks and benefits of remaining on Trikafta or stopping the drug during pregnancy.

Next Steps

Our understanding of Trikafta’s impact on fertility, pregnancy and lactation will increase over time and the CF research community is focused on gathering more information. Currently, a research team in the US is conducting a large observational study involving 40 CF care centers across the US to evaluate the impact of Trikafta on mothers and infants. This site will be updated as more information becomes available. If you have any questions, please contact your CF care team.