BREXAFEMME® Pregnancy Safety Study: For Healthcare Provider

About BREXAFEMME® Pregnancy Safety Study

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.

  • Have questions?

    Please call a safety study representative at 1‑888‑982‑7299
    for more information.

Patient eligibility criteria

Your patient may be an eligible candidate if:

  1. she has taken BREXAFEMME® during pregnancy or,
  2. conception is estimated to have occurred within 4 days after the last dose of BREXAFEMME®.
Contact me (HCP)

What are my responsibilities as a healthcare provider (HCP)?

As the HCP of a study participant, you will be contacted:
  • at the time of enrollment
  • at the end of 2nd trimester
  • about 4 weeks after the birth of the baby
As the HCP of a participant’s infant (in case of live birth), you will be contacted when the infant is:
  • 1 month old
  • 6 months old
  • 12 months old

What will my patient have to do once she is enrolled?

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 enrollment
  • end of each trimester
  • when infant is 1, 6 and 12 months old

At each time point, your patient will be asked to confirm her contact information.

Will I be compensated for my time as a healthcare provider?

Participation in the study is voluntary. No compensation will be provided.

How will the pregnancy safety study data be collected and stored?

  • Participants who join the BREXAFEMME® Pregnancy Safety Study will provide a medical release information form that will allow the safety study center to contact their healthcare providers. These contacts are necessary to obtain information on the participant’s pregnancy and delivery, and/or the health of their infant.
  • All clinical information requested in the protocol will be recorded on the defined forms. Once these forms are signed by the study representative, the data on these forms will be transferred to a safety database. An electronic file for each subject will be maintained that will include the signed ICF and the copies of all source documents related to that subject.
  • The data collected from all parties will be kept in a secure database as per our Privacy Policy. The health information of the patient and her infant will be kept anonymous and any identifying information will not be used.
How can I enroll my patient in the safety study?
Call the toll-free number 1‑888‑982‑7299 and speak to a study representative for registration information.

Assist your patient in filling out the contact form with their consent by clicking below link
Contact me (HCP).

Inform your patient that she may enroll by calling 1‑888‑982‑7299.

For the latest important safety information, please refer to the full Prescribing Information and Patient Information.