Approved Risk Evaluation and Mitigation Strategies (REMS)

Zilbrysq (zilucoplan)

NDA #216834

REMS last update: 01/16/2024

• View the Zilbrysq Prescribing Information at DailyMed
• View Zilbrysq's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the ZILBRYSQ REMS is to mitigate the risk of serious meningococcal infections.

1. Patients are vaccinated against meningococcal infections caused by Neisseria meningitidis serogroups A, C, W, Y (MenACWY) and serogroup B (MenB) prior to starting therapy according to the current Advisory Committee on Immunization Practices (ACIP) recommendations and receive antibacterial drug prophylaxis if needed.
2. Patients are aware of early signs and symptoms of meningococcal infection and the need for immediate medical evaluation.
3. Prescribers are aware of early signs and symptoms of meningococcal infection and the need for immediate medical evaluation.

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

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
01/16/2024	Modified to make changes to the Zilbrysq REMS website to: 1) correct typographical errors and formatting, and 2) add a new tab to the banner of the Pharmacy-Prescriber Look-up page which reduces pharmacy burden by improving ease of navigating the website to verify prescriber certification.
10/17/2023	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.