Gardener.

ZILBRYSQ REMS

ZILBRYSQ REMS (Risk Evaluation and Mitigation Strategy)1

Gardener.

ZILBRYSQ is available only through the ZILBRYSQ REMS, due to the risk of serious meningococcal infections1

What is REMS?

A REMS is a strategy to manage known or potential risks associated with a drug and is required by the FDA to ensure that the benefits of the drug outweigh the risks.2

ZILBRYSQ, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains.1

Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.

The initiation of ZILBRYSQ treatment is contraindicated in patients with unresolved serious Neisseria meningitidis infection.

All healthcare providers who prescribe ZILBRYSQ must be certified in the ZILBRYSQ REMS. Certification includes a review of REMS educational materials and enrollment into the ZILBRYSQ REMS, which can be found by visiting www.ZILBRYSQREMS.com.1

  • Prescribers must counsel patients about the risk of serious meningococcal infection
  • Prescribers must provide the patients with the REMS educational materials
  • Prescribers must assess patient vaccination status for meningococcal vaccines (against serogroups A, C, W, Y, and B) and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of ZILBRYSQ
  • Patients must be instructed to carry the Patient Safety Card with them at all times during and for 2 months following treatment discontinuation with ZILBRYSQ

ZILBRYSQ vaccination requirements1

  • Complete or update meningococcal vaccination (for serogroups A, C, W, Y, and B) at least 2 weeks prior to administration of the first dose of ZILBRYSQ, according to current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of ZILBRYSQ therapy

Note: ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information.

See vaccination schedule
  • If urgent ZILBRYSQ therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible.
  • The optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including ZILBRYSQ

CLOSELY MONITOR patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected

INSTRUCT patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early

INFORM patients of early signs and symptoms of meningococcal infection

CONSIDER INTERRUPTION of ZILBRYSQ in patients who are undergoing treatment for serious meningococcal infection, depending on the risks of interrupting treatment in the disease being treated

Vaccination does not eliminate the risk of meningococcal infections, despite development of antibodies following vaccination.

EXPLORE NEXT:
See vaccination schedule See ZILBRYSQ safety

References:

  1. ZILBRYSQ [Prescribing Information]. Smyrna, GA: UCB, Inc.
  2. Risk Evaluation and Mitigation Strategies (REMS). US Food & Drug Administration. Updated May 16, 2023. Accessed November 20, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems