Information for Healthcare Providers
The VYEPTI Pregnancy Registry was developed in collaboration with the FDA and H. Lundbeck A/S (Lundbeck), the manufacturer of eptinezumab-jjmr (VYEPTI®). This non-interventional study seeks to evaluate pregnancy-related health outcomes of a cohort of women who were exposed to VYEPTI at any time point during their pregnancy or up to 20 weeks prior to becoming pregnant, compared to a cohort of pregnant women who were exposed to other (non-CGRP-targeting) preventive migraine medications during their pregnancy and/or up to 1 week (depending on medication) prior to becoming pregnant.
The Registry also seeks to evaluate infant health outcomes including major congenital anomalies, postnatal growth, and development through one year of age in each cohort.
The lack of data on human pregnancy exposures to VYEPTI makes this post marketing observational study an essential component of the ongoing studies on the safety of this product. The success of the study is dependent upon the participation of eligible patients and healthcare providers. Thank you for your time and consideration.
Enrollment in the VYEPTI Pregnancy Registry is entirely voluntary and may be initiated by healthcare providers or pregnant women themselves who have received at least one dose of VYEPTI at any time point during their pregnancy or up to 20 weeks prior to becoming pregnant. Likewise, women who are pregnant who have taken other (non-CGRP-targeting) preventive migraine medications during their pregnancy and/or up to 1 week (depending on medication) prior to becoming pregnant may also be eligible to participate in the Registry. Eligible women will be asked to provide verbal consent and a written release of medical records relevant to the Registry prior to enrollment.
To enroll a patient or to request additional information:
If a woman is eligible for participation, she will be asked to read an informed consent document containing details about the Registry and requesting to collect personal health information from healthcare providers involved in the care of her pregnancy and that of her infant(s). After providing verbal informed consent, eligible women will be sent 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 Registry, patient brochures are available upon request.
Patient Brochure
Your patient's participation in the observational pregnancy study will last throughout her pregnancy and up to one year after her delivery date. Your patient will be contacted once per trimester, on the estimated date of delivery, and when her infant(s) is(are) 6 and 12 months of age to provide basic information about her pregnancy, post pregnancy health, her infant(s)'s health and any changes in migraine medication treatment. At each timepoint your patient will be asked to confirm her contact information. The patient will be also asked to record any information related to medication she is taking during the Registry in a patient diary electronically via an app or in a paper-based form.
A Registry representative will also contact their healthcare provider at two time points during the Registry: approximately 34 weeks of the pregnancy and within 2 weeks of their estimated delivery date.
In addition, a Registry representative will contact their infant(s)'s pediatrician when the baby(ies) is(are) approximately 6 and 12 months old to determine if there are any changes in baby(ies)'s health status.
If enrolled, patients can choose to end their participation at any time for any reason.
Your participation in the Registry as a healthcare provider will vary depending on if you are treating the patient or infant(s). If you are the woman's obstetrician, you will be contacted around 34th week of the patient's pregnancy and, again, within 2 weeks of their estimated delivery date. If you are the infant(s)'s pediatrician you will be contacted when the baby(ies) is(are) approximately 6 and 12 months old. In order to collect the information, the Pregnancy Registry Coordinating Center will contact you via email or phone to collect the necessary information and send questionnaires at the appropriate Registry timepoints for you to complete.
The Pregnancy Registry Coordinating Center is responsible for collecting and maintaining all the Registry data in accordance will 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 Registry administrator in accordance with their written security policy. Information about your patient and their infant(s)'s health collected during the Registry will be kept anonymous and any identifying information will not be used.
The success of the VYEPTI Pregnancy Registry depends on the continued participation of healthcare providers like you. We greatly appreciate your help with identifying and supporting eligible patient enrollment in the Registry, and in assisting with the collection of follow-up information during your patient's participation in the Registry.
For more information about Vyepti, please see the Full Prescribing Information.