Information for Health Care Providers

What is the EPIDIOLEX^® (cannabidiol) Pregnancy Surveillance Program and why is it important?

The EPIDIOLEX^® Pregnancy Surveillance Program was developed in collaboration with the FDA and Jazz Pharmaceuticals Research UK Limited, the manufacturer of EPIDIOLEX^® (cannabidiol). This observational study seeks to evaluate pregnancy-related health outcomes in women who have taken at least 1 dose of EPIDIOLEX in the 13 days before their last menstrual period prior to pregnancy or anytime during pregnancy and their babies up to 12 months of age who were exposed to at least 1 dose of EPIDIOLEX in utero.

Monitoring pregnancy exposure through surveillance programs and other studies is an important tool to gather data on the potential effects of medical products during pregnancy. Pregnant women are typically excluded from trials during clinical development, leading to a lack of information on the safety of medicines used during pregnancy in the post-marketing setting. The Food and Drug Administration (FDA) issued guidance in 2019 on pregnancy studies to the pharmaceutical industry, and this is now a common post-marketing requirement for many different medications, regardless of the indicated population.

Who is eligible to participate?

Women who have been exposed to at least 1 dose of EPIDIOLEX in the 13 days before their last menstrual period prior to pregnancy or any time during their pregnancy. This includes pregnancies identified both retrospectively (i.e., patient is no longer pregnant at the time of study enrollment) and prospectively (i.e., patient is still pregnant at the time of study enrollment).

When should pregnancies be reported?

As soon as it is determined that the patient was exposed to EPIDIOLEX within the defined pregnancy exposure window.

How do I enroll a patient in the study?

Report a Pregnancy

To enroll a patient or to request additional information:

• Call the Pregnancy Coordinating Center toll-free number at 855-272-7158, Monday through Friday 9:00 a.m. to 5:00 p.m. Eastern Time
• Fax the Pregnancy Coordinating Center at 866-750-0433
• Email the Pregnancy Coordinating Center at info@epidiolexpregnancystudy.com

If a woman is eligible to participate in the study, a study representative will request verbal consent to acknowledge her understanding of the study. After providing informed consent, eligible women will have the option to receive the Medical Information Release form by their preferred method of contact to sign, date, and return. If your patients are interested in learning more about the study, patient brochures are available upon request.

What will my patient's participation involve once she is enrolled?

After your patient is enrolled in the study, a study representative will be in contact at select time points to collect pregnancy-related health information. If currently pregnant, the patient will be contacted once during each trimester, and around the time of estimated delivery date or when your patient gives birth.

If your patient provides consent, a study representative will also contact their healthcare provider at two time points during the study: approximately at week 34 for prenatal follow-up and around the time of their estimated delivery date, or when they give birth.

In addition, a study representative will contact their infant's pediatrician at four points during the study: when their baby is 3, 6, 9 and 12 months of age.

After my patient is enrolled, what will my participation involve?

Your participation in the study as a healthcare provider will vary depending on if you are treating the patient or infant. If you are the woman's obstetrician, you will be contacted approximately at week 34 and, again, at their estimated delivery date, or when a live birth occurs.

If you are the infant's pediatrician, you will be contacted when the baby is 3, 6, 9, and 12 months of age. A study representative will contact you via email or phone to collect the necessary information and send questionnaires at the appropriate study timepoints for you to complete.

How will the data be collected?

The Pregnancy Coordinating Center is responsible for collecting and maintaining all the study data in accordance with all laws and applicable regulations. All data provided by you and/or your patient will be captured on a case report form. The case report form will be kept in a secure location by the study administrator in accordance with their written security policy. Information about your patient and their infant's health collected during the study will be kept anonymous and any identifying information will not be used.

The success of the study depends on the continued participation of healthcare providers like you. We greatly appreciate your help with identifying and enrolling patients in the study, and in assisting with the collection of follow-up information during your patient's participation in the study.