What is the ZILBRYSQ REMS (Risk Evaluation and Mitigation Strategy)?

A REMS is a strategy to manage known or potential risks associated with a drug and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. ZILBRYSQ has a REMS because it increases your chance of getting a meningococcal infection. The infection can quickly become life threatening or fatal if not recognized and treated early. ZILBRYSQ is only available through a restricted distribution program called the ZILBRYSQ REMS.

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

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.
Patients are aware of early signs and symptoms of meningococcal infection and the need for immediate medical evaluation.
Prescribers are aware of early signs and symptoms of meningococcal infection and the need for immediate medical evaluation.

What are the program requirements?

ZILBRYSQ is available exclusively through a restricted program under a REMS.

Prescribers and pharmacies must each be specially certified in order to prescribe or dispense ZILBRYSQ. Certification includes a review of REMS educational materials and enrollment into the ZILBRYSQ REMS.

Prescribers

Healthcare Providers must be certified in the ZILBRYSQ REMS in order to prescribe ZILBRYSQ.

Start Prescriber Enrollment

Patients

Receive or update both meningococcal vaccines prior to starting ZILBRYSQ therapy as directed by your prescriber. Understand the need for immediate medical attention for any signs or symptoms of meningococcal infection. Carry the Patient Safety Card at all times during treatment and for 2 months after your last ZILBRYSQ dose.

View Patient Guide

Pharmacies

Pharmacies should designate an Authorized Representative. Authorized Representatives must be certified in the ZILBRYSQ REMS in order to prescribe ZILBRYSQ.

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Wholesalers and Distributors

Wholesalers, distributors, and other entities that distribute ZILBRYSQ must ensure that ZILBRYSQ is distributed only to ZILBRYSQ REMS certified pharmacies.

List of Certified Pharmacies

Reporting Adverse Events:

Report any adverse events, including (suspected) meningococcal infections, to UCB, Inc. at 1-844-599-2273 and/or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Advisory Committee on Immunization Practices (ACIP) Guidelines:

ACIP recommendations are periodically updated. Therefore, please check the latest recommendations to ensure the vaccination status of your patients is up to date, to minimize the increased risk of meningococcal infection associated with ZILBRYSQ therapy for your patients.

Indication:

ZILBRYSQ is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.