The BLOOM Pregnancy Registry

What is the BLOOM Pregnancy Registry?

The BLOOM Pregnancy Registry was created to collect information about the possible effects of medications containing elagolix, such as ORIAHNN^® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), on pregnancy, delivery, and the health of babies.

The registry is looking for volunteers who were prescribed ORIAHNN by their doctor, but became pregnant while taking it. This registry is also looking for volunteers who are pregnant and have uterine fibroids. If you have uterine fibroids, you do not need to have taken ORIAHNN to take part in this registry. By sharing your experience, you could help doctors to better understand the possible effects of elagolix-containing medications on pregnancy, delivery, and the health of babies.

The BLOOM Pregnancy Registry will evaluate the pregnancy outcomes of the following 2 groups:

• women who were exposed to an elagolix-containing medication, such as ORIAHNN, during early pregnancy
• women who were not taking ORIAHNN when they became pregnant, but who have uterine fibroids.

Participants will be followed throughout their pregnancy and information on the health of participants’ babies will also be collected until the baby is 12 months old.

By joining this registry and sharing your information, pregnant women who are exposed to ORIAHNN in the future may have more information about how their pregnancies and babies may or may not be affected.

Important Safety Information: ORIAHNN should not be taken by women who are pregnant or trying to become pregnant as they may increase the risk of early pregnancy loss. Women who become pregnant while taking ORIAHNN should stop taking it right away and call their healthcare provider.

Can I take part in this registry?

You may be able to take part in this registry if you are pregnant, and:

• have taken ORIAHNN at any time after your last menstrual period, or
• have not taken ORIAHNN but have uterine fibroids.

What will I have to do?

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

If you decide to participate and verbally give your informed consent, then a registry representative will:

• ask questions to 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 6 months and 12 months old to ask questions about the baby’s health.

If you would like to have further information to discuss with a family member or your doctor, or to share with others, you can download a copy of the BLOOM Pregnancy Registry Patient Brochure.

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, the healthcare provider who is treating your uterine fibroids (if different than your regular obstetrician), and your baby’s healthcare provider. They will collect information about your general health, your pregnancy, and your baby’s health. Following your enrollment, a registry representative will:

• contact your healthcare providers 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 when your baby is about 6 and 12 months old to ask about the health of your baby.

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

If you participate in the registry, you will not:

• have any registry visits
• have any medical tests for the registry
• receive any medications for the registry.

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