The GENESIS Pregnancy Registry

What is the GENESIS Pregnancy Registry?

The GENESIS Pregnancy Registry is a United States registry for pregnant women diagnosed with migraine whom may or may not have taken Aimovig^® (erenumab-aooe) shortly before or during pregnancy.

By sharing your pregnancy information with this registry, you could help doctors better understand if Aimovig use before and during pregnancy affects pregnancy or newborns’ health. The possible effects will be compared with outcomes for women who have not taken Aimovig or any medication targeting the calcitonin gene-related peptide (CGRP) pathway, including Ajovy^® (fremanezumab-vfrm) and Emgality^® (galcanezumab-gnlm), shortly before or during their pregnancy, but who have been diagnosed with migraine. This study will follow participants throughout their pregnancy and collect health information about participants’ babies for 1 year.

You can support pregnant women in the future by joining the GENESIS Pregnancy Registry.

Can I take part in this registry?

You may be able to participate if you have been diagnosed with migraine, are currently pregnant, and:

• have taken Aimovig during the 16 weeks (about 4 months) before your last menstrual period and/or any time during pregnancy, or
• have not taken Aimovig or any medication targeting the calcitonin gene-related peptide (CGRP) pathway, including Ajovy^® (fremanezumab-vfrm) and Emgality^® (galcanezumab-gnlm), shortly before or during your pregnancy, and
• agree for you, your doctor and your baby’s doctor to provide information about your health, pregnancy, and delivery, and information on your baby’s health, to the registry team.

What will I have to do?

You will need to give written or electronic informed consent to participate in this pregnancy registry. A registry representative will speak with you over the phone to discuss the registry and what it involves. You can ask the representative any questions you may have before deciding if you want to join.

If you decide to take part and give your written or electronic informed consent, a registry representative will then:

• collect some information about you and your pregnancy via telephone
• call you once each trimester (about every 2–3 months) to ask if there have been any changes in your pregnancy, your general health, or the medicines you are taking
• call you about 4 weeks after you have given birth, and when your baby is approximately 3 months, 6 months, and 1 year old to ask questions about the baby’s health.

You can download a copy of the GENESIS Pregnancy Registry Patient Brochure if you would like to discuss the registry with others, like a family member or your doctor.

Why and when will my healthcare providers be contacted?

With your permission, a registry representative will contact the healthcare provider caring for you during your pregnancy or the healthcare provider who is treating your migraine, and your baby’s healthcare provider. They will collect information about your general health during pregnancy and your baby’s health. Following your enrollment, a registry representative will:

• contact your healthcare provider(s) 3 times in total; twice during your pregnancy, and once after your delivery, to ask about any changes in your pregnancy, general health, and treatment since the last call
• contact your baby’s healthcare provider about 4 weeks after you have given birth, and when your baby is approximately 3 months, 6 months, and 1 year old to ask questions about the baby’s health.

The contact you and your healthcare providers will receive is summarized in the diagram below.

If you participate in the registry, you will not need to:

• attend any extra healthcare provider visits for the study
• have any extra medical tests for the study
• receive any additional medications for the study.

What else will happen if I participate?

After you enroll in the registry, we will send you a welcome message by email. With your consent, we will also send you occasional emails and text messages to remind you about upcoming telephone interviews. You can choose to stop receiving these communications at any time. This will not affect your participation in the study.

Our Privacy Policy contains full details of our commitment to your privacy

Our FAQs contain answers to many frequently asked questions.

For the latest important safety information, please refer to the full Prescribing Information and Patient Information. This is not intended to replace discussions with your healthcare provider.