About the Evrysdi Pregnancy Registry
The Evrysdi Pregnancy Registry is a global observational registry of women with SMA who are or have been pregnant and have received Evrysdi® (risdiplam). The goal is to collect and describe the frequency of maternal, fetal, and infant outcomes among women with SMA exposed to risdiplam at any point from 14 days prior to their LMP or at any time during pregnancy.
It is hoped that this registry will help healthcare professionals to better understand if risdiplam has any effect on pregnancy, delivery, or the health of infants.
The Evrysdi Pregnancy Registry is listed on the US Food and Drug Administration (FDA) pregnancy exposure registries website.
Have questions?
Have questions?
Please call the coordinating center at
(001) 833-760-1098 for more information.
Patient eligibility criteria
Your patient is potentially eligible to participate in this registry if they:
OR
Consent will be obtained prior to enrollment. Consent will be obtained in compliance with any country-specific regulations or requirements. In particular, for eligible patients less than 18 years of age, consent must be obtained from the patient’s legally authorized representative.
What are my responsibilities as a healthcare provider (HCP)?
As the HCP of a study participant, you will be contacted:
- when your patient enrolls in the registry
- during your patient’s second trimester (at about 21 weeks)
- about 4 weeks after your patient’s expected date of delivery
As the HCP of a participant’s infant, you will be contacted when the infant is about:
- 1 month old
- 3 months old
- 6 months old
- 12 months old
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 is enrolling retrospectively (e.g. after the pregnancy outcome), all information on the pregnancy and any infant outcomes will be collected at the study entry. If the infant of the retrospectively enrolled patient is less than 1 year old, they will be prospectively followed until 1 year of age.
What will my patient have to do once they are enrolled?
If your patient consents and is eligible to take part, they will be asked to share information about themself, their health and their pregnancy, and will be contacted:
- at enrollment
- during each trimester
- within 4 weeks of their estimated date of delivery, following their infant’s birth
- when their infant is 3, 6, and 12 months old
At each time point, your patient will be asked to confirm their contact information.
How will the registry data be collected and stored?
Participants who join the Evrysdi Pregnancy Registry will provide a Release of Medical 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 their infant.
The Registry Coordinating Center will collect the information provided by the patient and the healthcare provider. The data collected from all parties will be entered in secure electronic systems and the companies who work with the Sponsor may operate these systems. Personal Data will be stored for the period requested by local regulations after the end of the study. The health information of the patient and of their infant will be kept anonymous and any identifying information will not be used.
How can my patient enroll in the registry?
Inform your patient that they may enroll in the registry by calling (001) 833-760-1098 or by sending an email to hdvchpedsneuromuscul@spectrumhealth.org. Inform your patient that the study doctor or member of the study team designated by the study doctor will ask for your patient’s contact information so that they can provide more information about the registry and follow the next steps for enrollment.
How can I enroll my patient in the registry?
Call the coordinating center at (001) 833-760-1098
Call nowContact the coordinating center by email: hdvchpedsneuromuscul@spectrumhealth.org
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.