Important Safety Information: ORILISSA 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 a medication containing ORILISSA should stop taking it right away and call their healthcare provider.
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The BLOOM Pregnancy Registry was established to help determine the frequency of major congenital malformations at birth and through the first year of life in infants of women who were exposed to an elagolix-containing medication during pregnancy.
Pregnancy is something that many women with endometriosis may have thought about or experienced, because endometriosis often first affects women when they are of childbearing age1.
Many of the available treatments for endometriosis, ORILISSA® (elagolix tablets) included, are not approved for use during pregnancy.2 Often, the effect of these medications or treatments on pregnancy, or the health of an unborn infant, is not known because pregnant women are often excluded from research studies. It is hoped that this registry will help doctors to better understand if ORILISSA has any effect on pregnancy, delivery, or the health of infants, since women may have taken ORILISSA before realizing they were pregnant.
ORILISSA is contraindicated in women who are pregnant. Exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss.
Information about this registry is available at clincialtrials.gov (NCT04464187). You may also search for ORILISSA on the US Food and Drug Administration (FDA) pregnancy exposure registries website.
Please call a registry representative at 1-(833)-782-7241 for more information.
Your patient is potentially eligible to participate in this registry if she is pregnant, and:
As the HCP of a study participant, you will be contacted:
As the HCP of a participant’s infant, you will be contacted when the infant is about:
At each contact point, you or your staff will be requested to:
The worksheets should take no more than 10–15 minutes to complete. The information requested will be obtained from your patient’s medical record.
If your patient consents and is eligible to take part, she will be asked to share information on her health, lifestyle, and pregnancy, and will be contacted:
At each time point, your patient will be asked to confirm her contact information.
You will not be compensated for your time. However, the information that you provide will help us learn more about the possible effects of ORILISSA on pregnancy, delivery, and the health of infants whose mothers were exposed to ORILISSA during pregnancy. In the future, it is hoped that the results of the registry will help you and your colleagues, along with your patients, make more informed decisions about the use of ORILISSA.
Women who join the BLOOM Pregnancy Registry will provide a release of information form that will allow the Registry Coordinating Center to contact their healthcare providers. These contacts are necessary to obtain information on the participant’s pregnancy and delivery, and/or the health of her infant.
When asked by the Registry Coordinating Center (RCC), please download, complete, and submit the applicable worksheet for your patient by fax 1-(833)-318-1043 or email to BloomPregnancyRegistry@IQVIA.com .
For the latest important safety information, please refer to the full Prescribing Information.
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