BREXAFEMMEŽ (ibrexafungerp) Pregnancy Registry

This is a prospective, observational cohort study designed to monitor pregnancy outcomes in women who were exposed to BREXAFEMMEŽ (ibrexafungerp tablets) at any time during pregnancy or whose conception occurred within four days after receiving the last dose of the treatment.

BREXAFEMMEŽ is contraindicated during pregnancy because animal studies suggest it may cause harm to the foetus. The purpose of this registry is to collect information on pregnancy outcomes (such as live birth, abortion, or stillbirth) and pregnancy-related complications in women who have taken BREXAFEMMEŽ during pregnancy. The study also gathers selected information on infants at birth and through the first year of life.

Participants will be observed throughout pregnancy, and infants will be monitored from birth until 12 months of age.

Patient Participation involves:

• Voluntary registration after providing informed consent.
• Completing an initial screening questionnaire, follow-up questionnaires during each trimester, a pregnancy outcome questionnaire within one month of delivery, and a paediatric follow-up questionnaire to track infant development up to one year of age.

Participants may withdraw from the study at any time. This is a strictly observational study: no medication will be provided as part of participation.

Eligibility Criteria:

You may participate in this study:

1. If you have taken BREXAFEMMEŽ while pregnant, or
2. Conception is estimated to have occurred within 4 days after your last dose of BREXAFEMMEŽ.
3. You (and/or your parent/legal representative) provide consent to participate and agree to the study requirements, including the interview schedule and release of medical records.

Eligibility Criteria:

Phone: GSK GRC on 1-888-825-5249

Email: us.naps@gsk.com

Enrolment:

• Woman can self-enrol in the study by calling 1-888-825-5249, or their healthcare provider can enrol them on their behalf with consent.
• Estimated annual enrolment: 5 participants per year.
• Study Start Date: August 2022
• Estimated Study End Date: June 2029