The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
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 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.
Enroll by completing and submitting the Prescriber Enrollment Form to
the REMS.
| Prescriber Enrollment Form |
Before treatment initiation
Assess the patient for unresolved meningococcal infection.
For patients with unresolved meningococcal infection: Not initiate
ZILBRSYQ.
Assess the patient's vaccination status for meningococcal serogroups A,
C, W, and Y (MenACWY) and serogroup B (MenB) and vaccinate as
needed according to the current Advisory Committee on Immunization
Practices (ACIP) recommendations for meningococcal vaccinations in
patients receiving a complement inhibitor.
For patients who are not up to date with MenACWY and MenB vaccines
at least two weeks prior to initiation of treatment and who must start
ZILBRYSQ urgently: Provide the patient with a prescription for
antibacterial drug prophylaxis.
Counsel the patient using the Patient Safety Card and Patient Guide.
Counsel the patient to carry the Patient Safety Card at all times during
and for 2 months following treatment with ZILBRYSQ. Provide a copy of
the materials to the patient.
| Patient Safety Card |
| Patient Guide |
During treatment
Assess the patient for early signs and symptoms of meningococcal
infection and evaluate immediately, if infection is suspected.
For patients who are being treated for meningococcal infection:
Withhold administration of ZILBRYSQ.
Revaccinate patients according to the current Advisory Committee on
Immunization Practices (ACIP) recommendations on meningococcal
vaccinations for patients receiving a complement inhibitor.
At all times
Report adverse events suggestive of meningococcal infection, including
the patient’s clinical outcomes, to UCB, Inc.
Patients who are prescribed ZILBRYSQ:
Before treatment initiation
Get both meningococcal vaccines (MenACWY and MenB) as directed
by your prescriber.
Take antibiotics as directed by your prescriber if you have to start
ZILBRYSQ right away.
Receive counseling from the prescriber using the Patient Safety Card
and Patient Guide.
| Patient Safety Card |
| Patient Guide |
Get additional meningococcal vaccines as directed by your prescriber.
At all times during treatment and for 2 months after the last dose
Inform the prescriber or get emergency medical care right away if
any of the following occur: headache with nausea or vomiting, stiff
neck, stiff back, or fever; fever with or without rash; sensitivity of
eyes to light; confusion; muscle aches with flu-like symptoms.
Designate an Authorized Representative to carry out the certification
process and oversee implementation and compliance with the REMS
on behalf of the pharmacy.
Have the Authorized Representative enroll in the REMS by completing
and submitting the Pharmacy Enrollment Form to the REMS.
| Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing ZILBRYSQ using the
Healthcare Provider Safety Brochure.
| Healthcare Provider Safety Brochure |
Establish processes and procedures to verify the prescriber is certified
and document the findings.
Establish processes and procedures to contact the prescriber to
assess the patient’s vaccination status for up to date meningococcal
vaccines (MenACWY and MenB) according to the current Advisory
Committee on Immunization Practices (ACIP) recommendations
including antibacterial drug prophylaxis if needed before treatment
initiation and document the findings.
For patients who are not up to date with meningococcal vaccines
when starting treatment: Establish processes and procedures to
assess the patient’s vaccination status for up to date meningococcal
vaccines including antibacterial drug prophylaxis if needed by
contacting the prescriber before dispensing prescriptions up to 6
months after the first dose and document the findings.
Before dispensing, first dose
Verify the prescriber is certified and document the findings through
the processes and procedures established as a requirement of the
REMS.
Assess the patient’s vaccination status for up to date meningococcal
vaccines (MenACWY and MenB) including antibacterial drug
prophylaxis if needed by contacting the prescriber and document the
findings through the processes and procedures established as a
requirement of the REMS.
Before dispensing, up to 6 months after the first dose
Verify the prescriber is certified and document the findings through
the processes and procedures established as a requirement of the
REMS.
For patients who are not initially up to date with meningococcal
vaccines when starting treatment: Assess the patient’s vaccination
status for up to date meningococcal vaccines (MenACWY and MenB)
including antibacterial drug prophylaxis if needed by contacting the
prescriber and document the findings through the processes and
procedures established as a requirement of the REMS.
Before dispensing, 6 months after the first dose and thereafter
Verify the prescriber is certified and document the findings through
the processes and procedures established as a requirement of the
REMS.
To maintain certification to dispense
If the Authorized Representative changes, have a new Authorized
Representative enroll in the REMS by completing and submitting the
Pharmacy Enrollment Form to the REMS.
| Pharmacy Enrollment Form |
At all times
Report adverse events suggestive of meningococcal infection to UCB,
Inc.
Not distribute, transfer, loan, or sell ZILBRYSQ, except to certified
pharmacies.
Maintain records of staff’s completion of REMS training
Maintain records that all processes and procedures are in place and
are being followed.
Comply with audits carried out by UCB, Inc. or a third party acting on
behalf of UCB, Inc. to ensure that all processes and procedures are in
place and are being followed.
Wholesalers, distributors, and other entities that distribute ZILBRYSQ must:
To be able to distribute
Establish processes and procedures to ensure that the drug is
distributed only to certified pharmacies.
Train all relevant staff involved in distributing ZILBRYSQ on the REMS
requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of all drug distributions.
Comply with audits carried out by UCB, Inc. or a third party acting on
behalf of UCB, Inc. to ensure all processes and procedures are in
place and are being followed.
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.
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.
