Information for Patients

Who can participate?

What is the VYEPTI Pregnancy Registry?

H. Lundbeck A/S (Lundbeck), the manufacturer of eptinezumab-jjmr (VYEPTI®), is conducting the VYEPTI Pregnancy Registry. This is an observational study in pregnant women diagnosed with migraine and treated with VYEPTI during pregnancy or up to 20 weeks prior to becoming pregnant. The purpose of this study is to collect and process data of pregnant women and their unborn and newborn baby(ies) to assess the use of VYEPTI or other preventive migraine medications in pregnancy. In addition, infant health outcomes will be collected up to the infant's first birthday.

During the development of pharmaceutical products, pregnant women are typically excluded from clinical trials and therefore, limited information is available on the use of VYEPTI during pregnancy. Information obtained from this study may assist health care providers and future pregnant women in weighing the risks and benefits of being treated with VYEPTI during pregnancy.

This is an observational study which means you and your infant(s) will continue to receive healthcare as decided by your healthcare provider(s). Participation in this study will not impact you or your infant(s)'s treatment or care. You and your infant(s) will continue to receive standard care as decided by your healthcare provider(s).

Who can participate in the VYEPTI Pregnancy Registry?

  • Women diagnosed with migraine who have received VYEPTI any time during their pregnancy or up to 20 weeks prior to becoming pregnant; and/or
  • Women diagnosed with migraine who have taken other preventive medication for migraine during their pregnancy and/or up to 1 week (depending on medication) prior to becoming pregnant. Preventive medications can include, but are not limited to, amitriptyline, venlafaxine, divalproex, topiramate, valproate, atenolol, metoprolol, propranolol, nadolol, timolol, and onabotulinumtoxin A.

Why should I participate in this Registry?

By participating in this Registry, you and your infant(s) will provide important information to help Lundbeck in collecting data on the use of VYEPTI and other preventive migraine medications in women during their pregnancy and follow their infant(s)'s growth and development up to their first birthday.

Your decision to participate in this Registry is entirely voluntary. Information about your health while you are enrolled in the Registry will be kept strictly confidential and anonymous, and any identifying information will not be used.

If enrolled, you can choose to end your participation at any time for any reason.

Who can participate?
Who can participate?

How can I enroll?

BY PHONE: Call the VYEPTI Pregnancy Registry Coordinating Center at 1-855-810-8549 between the hours of 8:00am-5:00pm, M-F Eastern Time

BY EMAIL: Email VYEPTI Pregnancy Registry Coordinating Center at vyeptipregnancyregistry@ubc.com

ONLINE: "Click" on the link to Report a Pregnancy*

* After you provide your contact information, a Registry representative from the Pregnancy Registry Coordinating Center will contact you to answer any of your questions and confirm your eligibility to participate in the Registry. If you prefer you may also ask your healthcare provider to support you with enrollment to the Registry.

If you are eligible and would like to participate, you will be asked to provide your informed consent to acknowledge your understanding of the Registry and to provide your permission for your personal and infant(s)'s healthcare information to be collected. If you are interested in participating, please contact the VYEPTI Pregnancy Registry Coordinating Center. After consent is received, a Registry representative will contact your healthcare provider to confirm your personal health information.

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Informed Consent Form

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Informed Assent Form

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Medical Information Release Form

Report a Pregnancy

What will my participation involve once I am enrolled?

There is no direct benefit for you or your newborn baby(ies) for participating in this study. However, your participation in this study will help Lundbeck collect data on effects of VYEPTI in pregnant women or babies whose mothers were exposed to VYEPTI during pregnancy.

Your participation in the Registry will last throughout your pregnancy and up to one year after your delivery date. You will be contacted by the Pregnancy Registry Coordinating Center during the last month of the second trimester of your pregnancy, on the estimated date of delivery, when your baby(ies) is(are) 6 and 12 months of age, and periodically throughout the study to collect medication usage from your participant diary. At each timepoint you will be asked to confirm your contact information.

You will be asked to record any information related to medication you are taking during your participation in a patient diary electronically via an app or in a paper-based form.

A Registry representative will also contact your healthcare provider at two time points during your participation: approximately 34 weeks of your pregnancy and within 2 weeks of your estimated delivery date.

In addition, a Registry representative will contact your infant(s)'s pediatrician when your baby(ies) is(are) approximately 6 and 12 months old to determine if there are any changes in your baby(ies)'s health status.

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For more information about Vyepti, please see Patient Information at the following link
Patient Information