This is a safety study for women who may have taken BREXAFEMME® at any time during pregnancy or whose conception is estimated to have occurred within four days after receiving the last dose of BREXAFEMME®. The study is strictly observational. No medication will be given as a part of the study protocol. The study is primarily focused on monitoring for potential pregnancy outcomes and complications. A special emphasis will be monitoring selected fetal/neonatal/infant outcomes at birth and through the first year of life if born to women taking BREXAFEMME® during the defined pregnancy exposure window.
This is an ongoing evaluation of women taking ibrexafungerp while pregnant. It is hoped that this safety study will help healthcare professionals better understand whether BREXAFEMME® has any effect on pregnancy, delivery, or the health of infants.
The BREXAFEMME® Pregnancy Safety Study is listed on the U.S. Food and Drug Administration (FDA) pregnancy exposure registries website.
Please call a safety study representative at 1‑888‑982‑7299
for more information.
Your patient may be an eligible candidate if:
If your patient consents and is eligible to take part, she will be asked to share information about herself, her health, and her pregnancy, and will be contacted:
At each time point, your patient will be asked to confirm her contact information.
Participation in the study is voluntary. No compensation will be provided.
For the latest important safety information, please refer to the full Prescribing Information and Patient Information.