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Approved Risk Evaluation and Mitigation Strategies (REMS)

Ultomiris (ravulizumab-cwvz)
BLA #761108
REMS last update: 08/03/2022

What is the purpose of the REMS?

The goals of the REMS are:
  1. To mitigate the occurrence and morbidity associated with meningococcal infections
  2. To educate healthcare providers and patients regarding:
    1. the increased risk of meningococcal infections with ULTOMIRIS
    2. the early signs of invasive meningococcal infections, and
    3. the need for immediate medical evaluation of signs and symptoms consistent with possible 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 See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe ULTOMIRIS must:

To become certified to prescribe
Before treatment initiation at least 2 weeks prior to first dose
  • Assess the patient’s meningococcal vaccine status and immunize patients.
  • Provide the patient with a prescription for a 2-week course of antibiotic prophylaxis if ULTOMIRIS must be started less than 2 weeks after the patient was immunized.
  • Counsel the patient using the Patient Safety Card and Patient Safety Brochure. Provide a copy of the materials to the patient.
    | Patient Safety Brochure | | Patient Safety Card |
During treatment
  • Assess the patient for early signs of meningococcal infection and evaluate immediately, if infection is suspected.
  • Consider discontinuation of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infection.
  • Revaccinate patients according to the Advisory Committee on Immunization Practices recommendations.
At all times
  • Report cases of meningococcal infection, including the patient’s clinical outcomes to Alexion Pharmaceuticals, Inc.

Patients who are prescribed ULTOMIRIS:

Before treatment initiation, at least 2 weeks prior to the first dose
  • Get meningococcal vaccines as directed by your doctor.
  • Take antibiotics as directed by your doctor for two weeks after you get your vaccine if you have to start ULTOMIRIS right away.
  • Receive counseling from the prescriber using the Patient Safety Card and Patient Safety Brochure.
    | Patient Safety Brochure | | Patient Safety Card |
During treatment
  • Get meningococcal vaccines as directed by your doctor.
At all times
  • Inform the prescriber or get emergency medical care right away if you experience headache with nausea or vomiting; headache and a fever; headache with a stiff neck or stiff back; fever; fever and a rash; confusion; muscle aches with flu-like symptoms; eyes sensitive to light.
At all times during treatment and for 8 months after the last dose
  • Have the Patient Safety Card with you

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_2022_08_03_Patient_Safety_Brochure.pdf
Patient Safety Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_Patient_Safety_Card.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_Prescriber_Enrollment_Form.pdf
Prescriber Safety Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_Prescriber_Safety_Brochure.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_REMS Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2022_08_03_REMS_Program_Website_Screenshots.pdf

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
08/03/2022 Revised to reflect editorial change.
07/22/2022 Modified to change the REMS document to align with labeling and updated REMS materials to incorporate the revised logo capturing both intravenous and subcutaneous routes of administration.
04/27/2022 Modified to revise Prescriber Safety Brochure to include the indication for generalized myasthenia gravis. In addition, changes to all educational REMS materials were made to align with labeling.
11/23/2021 Modified to:
  1. Update the Prescriber Enrollment Form to remove the “Other (please specify):” from the Credentials Box and a change in font color from orange to blue to highlight the website address and email address.
  2. Change the Prescriber Safety Brochure to update the indication sentence for PNH to include pediatric (one month and older) patients.
  3. Update the copyright date on all REMS materials.
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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