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About the BlossoMS Pregnancy Registry

The BlossoMS Pregnancy Registry was established to help determine how often major congenital malformations may occur at birth and through the first year of life in infants whose mothers were exposed to Vumerity® (diroximel fumarate) during pregnancy.

The effect of medications or treatments on pregnancy, or the health of babies, may not be known because pregnant women are often not allowed to participate in research studies. It is hoped that this registry will help doctors to better understand if diroximel fumarate has any effect on pregnancy, delivery, or the health of infants, as women may be exposed to diroximel fumarate during pregnancy. This information will be compared with data from women who have not had any MS therapy while pregnant. It is not known whether diroximel fumarate will harm unborn babies.

Information about this registry is available at clincialtrials.gov (NCT05658497). You may also search for Vumerity on the US Food and Drug Administration (FDA) pregnancy exposure registries website.

Have questions?

Have questions?

Please call a registry representative at 1 (833) 569-2635 for more information.

Eligibility Criteria?

Your patient is potentially eligible to participate in this registry if she is pregnant, and:

  • has been diagnosed with multiple sclerosis (MS), and

  • at any time from 2 weeks after the first day of her last menstrual period, either:

    • has taken Vumerity® (diroximel fumarate), or

    • has not taken any disease-modifying MS treatment.

Refer a patient

What are my responsibilities as a healthcare provider (HCP)?

As the HCP of a study participant, you will be contacted:

  • When your patient enrolls
  • During your patient’s second trimester (at approximately 24–28 weeks)
  • 4 weeks after your patient’s estimated 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
  • 12 months old

At each contact point, you or your staff will be requested to:

1 Download a PDF worksheet from the Resources section
2 Fill out the worksheet electronically
3 Return the worksheet by fax or email to the Registry Coordinating Center

The worksheets should take no more than 10–15 minutes to complete. The information requested will be obtained from your patient’s medical record.

What will my patient have to do once she is enrolled?

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 enrollment
  • once during each trimester
  • if her HCPs are unable to be reached during her second trimester or 1, 3, or 12 months after her delivery

At each time point, your patient will be asked to confirm her contact information.

Will I be compensated for my time as a healthcare provider?

You will not be compensated for your time. However, the information that you provide will help us learn more about the possible effects of Vumerity® (diroximel fumarate) on pregnancy, delivery, and the health of infants whose mothers were exposed to diroximel fumarate 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 diroximel fumarate.

How will the registry data be collected and stored?

Women who join the BlossoMS 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.

The Registry Coordinating Center will collect the information provided by the patient along with the forms submitted from the healthcare providers. The data collected from all parties will be kept in a secure database as per our privacy policy. The health information of the patient will be kept anonymous and any identifying information will not be used.

How can I enroll my patient in the registry?

Contact the Registry Coordinating Center (RCC) at 1-(833)-569-2635 for registration information

Assist your patient in filling out the contact form on the website or register your patient’s interest with their consent by clicking the link below

Inform your patient that she may enroll in the registry by calling 1 (833) 569-2635

Resources

When asked by the Registry Coordinating Center (RCC), please download, complete, and submit the applicable worksheet for your patient by fax 1 (833) 569-2635 or email to BlossoMSPregnancyRegistry@IQVIA.com .

Patient HCP Worksheets

Infant HCP Worksheets
Download all resources

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.