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

Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors; ZILBRYSQ is a complement inhibitor.1

The use of ZILBRYSQ increases a patient's susceptibility to serious and life-threatening meningococcal infections (septicemia and/or meningitis) caused by any serogroup, including non-groupable strains.

ZILBRYSQ is contraindicated in patients with unresolved 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 meningococcal infection
  • Prescribers must provide the patients with the REMS educational materials
  • Prescribers must assess patient vaccination status for both meningococcal vaccines (MenACWY and MenB)
  • 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 both MenACWY and MenB) at least 2 weeks prior to administering the first dose of ZILBRYSQ, according to current ACIP recommendations for meningococcal vaccinations in 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 both MenACWY and MenB vaccines according to ACIP recommendations, administer meningococcal vaccine(s) as soon as possible and provide the patient with antibacterial drug prophylaxis
  • 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. 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

WITHHOLD administration of ZILBRYSQ in patients who are undergoing treatment for meningococcal infection until the infection is resolved

Because of inhibition of complement activity by ZILBRYSQ and risk of infection caused by non-groupable strains of N. meningitidis, 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