Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Ultomiris (ravulizumab-cwvz)

BLA #761108

REMS last update: 12/21/2018

Goals
Summary
REMS Materials
Update history

What is the purpose of the REMS?

The goals of the REMS are:

To mitigate the occurrence and morbidity associated with meningococcal infections
To educate healthcare providers and patients regarding:

the increased risk of meningococcal infections with Ultomiris
the early signs of invasive meningococcal infections, and
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

Healthcare Providers who prescribe Ultomiris must:

To become certified to prescribe	Review the drug's Prescribing Information. Review the following: Patient Safety Card, Prescriber Safety Brochure, and Patient Safety Brochure. Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
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.
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 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.
During treatment	Get meningococcal vaccines as directed by your doctor.
At all times	Have the Patient Safety Card with you. 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.

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_2018_12_21_Patient_Safety_Brochure.pdf
Patient Safety Card (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_Patient_Safety_Card.pdf
Prescriber Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_Prescriber_Enrollment_Form.pdf
Prescriber Safety Brochure (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_Prescriber_Safety_Brochure.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_REMS_Full.pdf
REMS Program Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ultomiris_2018_12_21_REMS_Program_Website_Screenshots.pdf

What updates have been made to the REMS?

Date	Summary of change
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.