Approved Risk Evaluation and Mitigation Strategies (REMS)
Ultomiris (ravulizumab-cwvz)
BLA #761108
REMS last update: 04/30/2020
What is the purpose of the REMS?
The goals of the REMS are:- To mitigate the occurrence and morbidity associated with meningococcal infections
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
View application holder(s) REMS Website
Healthcare Providers who prescribe Ultomiris must:
To become certified to prescribe |
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Before treatment initiation and at least 2 weeks prior to first dose |
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During treatment |
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At all times |
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Patients who are prescribed Ultomiris:
Before treatment initiation, at least 2 weeks prior to the first dose |
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During treatment |
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At all times |
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What materials are included in the REMS?
The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Ultomiris REMS, see the DailyMed link(s).Material Name | Material Name Link |
---|---|
Patient Safety Brochure (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_Patient_Safety_Brochure.pdf |
Patient Safety Card (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_Patient_Safety_Card.pdf |
Prescriber Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_Prescriber_Enrollment_Form.pdf |
Prescriber Safety Brochure (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_Prescriber_Safety_Brochure.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020-04_30_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_REMS_Full.pdf |
REMS Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2020_04_30_REMS_Website_Screenshots.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
04/30/2020 | Modified to make changes to the Prescriber Enrollment Form to include the prescriber specialty and reformat this form from two pages to one page. |
10/18/2019 | Modified to reflect changes to the Prescriber Safety Brochure including adding the new indication. |
12/21/2018 | Approval of the REMS. |
Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.
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