The Ultomiris Pregnancy Registry Study

What is the Ultomiris Pregnancy Registry Study?

The Ultomiris Pregnancy Registry Study will collect information about the possible effects of ULTOMIRIS on pregnancy, delivery, and the health of babies.

The pregnancy registry study is looking for volunteers who:

• are pregnant or were previously pregnant
• have paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG) or neuromyelitis optica spectrum disorder (NMOSD).

Volunteers must also have received treatment with ULTOMIRIS prior to pregnancy, during pregnancy, or while breastfeeding.

You could help doctors to better understand the possible effects of ULTOMIRIS on pregnancy, delivery, and the health of babies.

People who take part in the registry study will be asked to share and allow their doctors to share information about their pregnancy. Information on the health of participants’ babies also will be collected until the baby is 1 year old.

If you decide to join this pregnancy registry study and share your information, you may help other women in the future. The findings may help pregnant women exposed to ULTOMIRIS to have more information about how ULTOMIRIS may or may not affect their pregnancy and baby.

Can I take part in this pregnancy registry study?

You may be able to take part in this registry study if you are or were previously pregnant, and took ULTOMIRIS:

• at any time during your pregnancy, or
• up to about 9 months before you got pregnant, or
• at any time while breastfeeding.

You do not have to currently be pregnant to take part in this registry study.

What will I have to do?

To take part in this pregnancy registry study, you will first be asked to give verbal or written informed consent during a telephone interview with a study representative. You will receive information about the registry study and what it will involve, have a chance to ask any questions, and decide if you want to take part.

If you decide to take part and give consent to access your medical records and to allow us to contact you, your doctor, and/or your baby’s doctor, a study representative may call you on the phone:

• to ask questions and collect some information about you and your pregnancy,
• once each trimester (about every 1–3 months) and one month after estimated due date to ask if you have had any changes in your pregnancy, your general health, or the medicines you take,
• when your baby is about 3, 6, and 12 months old, to find out about your baby’s health and breastfeeding (if applicable).
• If you are no longer pregnant when you join the Ultomiris Pregnancy Registry Study, the study representative may call once when you join as well as the listed timepoints until your baby is 12 months old.

For more information about the registry study to discuss with a family member, your doctor, or healthcare provider, or to share with others, you can download the Ultomiris Pregnancy Registry Study Patient Brochure.

Why and when will my healthcare providers be contacted?

Following your enrollment, with your permission, a study representative may contact:

• the doctor or healthcare provider caring for you during your pregnancy,
• the healthcare provider who is treating your condition (if different than your regular obstetrician), and
• your baby’s healthcare provider.

The study representative will collect information about your general health, your pregnancy, and your baby’s health For any follow-up calls, they will ask about your pregnancy, general health, and treatment or your baby’s health since the last call.

If you join the pregnancy registry study, you will not:

• have any visits to a doctor or healthcare professional as part of the registry study
• have any medical tests for the registry study
• receive any medications for the registry study.

What else will happen if I participate?

After you enroll in the pregnancy registry study, we will send you a welcome message by email.

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 Medication Guide. This is not meant to replace discussions with your healthcare provider.