FDA.reportPublic FDA data

ZILBRYSQ - UCB, Inc.

Manufacturer
UCB, Inc.
Effective date
2024-01-01
Label type
RISK EVALUATION & MITIGATION STRATEGIES
Version
4
Source
full-release
Hydrated at
2026-06-04 22:50:39

Label at a glance#

ProductZILBRYSQ
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS Administrative Information

Risk: Serious meningococcal infections

Application Number: NDA 216834

Application Holder: UCB, Inc.

Initial REMS Approval: 10/2023

II. REMS Goal

REMS Goals

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.

III. REMS Requirements

REMS Requirements

REMS Participant Requirements

UCB, Inc. must ensure that healthcare providers, patients, pharmacies, and wholesalers, distributors, and other entities that distribute ZILBRYSQ comply with the following requirements:

1. Healthcare providers who prescribe ZILBRYSQ must:

SPL UNCLASSIFIED SECTION

To become certified to prescribe

  1. Review the drug’s Prescribing Information.
  2. Review the following: Healthcare Provider Safety Brochure, Patient Guide, and Patient Safety Card.
  3. Enroll by completing and submitting the Prescriber Enrollment Form to the REMS.

Before treatment initiation

  1. Assess the patient for unresolved meningococcal infection.
  2. For patients with unresolved meningococcal infection: Not initiate ZILBRYSQ.
  3. 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.
  4. 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.
  5. 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.

During treatment

  1. Assess the patient for early signs and symptoms of meningococcal infection and evaluate immediately, if infection is suspected.
  2. For patients who are being treated for meningococcal infection: Withhold administration of ZILBRYSQ.
  3. 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

  1. Report adverse events suggestive of meningococcal infection, including the patient’s clinical outcomes, to UCB, Inc.
2. Patients who are prescribed ZILBRYSQ:

SPL UNCLASSIFIED SECTION

Before treatment initiation

  1. Get both meningococcal vaccines (MenACWY and MenB) as directed by your prescriber.
  2. Take antibiotics as directed by your prescriber if you have to start ZILBRYSQ right away.
  3. Receive counseling from the prescriber using the Patient Safety Card and Patient Guide.
  4. Get the Patient Safety Card and Patient Guide from your prescriber.

During treatment

  1. Get additional meningococcal vaccines as directed by your prescriber.

At all times during treatment and for 2 months after the last dose

  1. 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.
  2. Have the Patient Safety Card with you.
3. Pharmacies that dispense ZILBRYSQ must:

SPL UNCLASSIFIED SECTION

To become certified to dispense

  1. Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
  2. Have the Authorized Representative review the Healthcare Provider Safety Brochure.
  3. Have the Authorized Representative enroll in the REMS by completing and submitting the Pharmacy Enrollment Form to the REMS.
  4. Train all relevant staff involved in dispensing ZILBRYSQ using the Healthcare Provider Safety Brochure.
  5. Establish processes and procedures to verify the prescriber is certified and document the findings.
  6. 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.
  7. 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

  1. Verify the prescriber is certified and document the findings through the processes and procedures established as a requirement of the REMS.
  2. 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

  1. Verify the prescriber is certified and document the findings through the processes and procedures established as a requirement of the REMS.
  2. 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

  1. 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

  1. 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.

At all times

  1. Report adverse events suggestive of meningococcal infection to UCB, Inc.
  2. Not distribute, transfer, loan, or sell ZILBRYSQ, except to certified pharmacies.
  3. Maintain records of staff’s completion of REMS training.
  4. Maintain records that all processes and procedures are in place and are being followed.
  5. 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.
4. Wholesalers, distributors, and other entities that distribute ZILBRYSQ must:

SPL UNCLASSIFIED SECTION

To be able to distribute

  1. Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
  2. Train all relevant staff involved in distributing ZILBRYSQ on the REMS requirements.

At all times

  1. Distribute only to certified pharmacies.
  2. Maintain records of all drug distributions.
  3. 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.

REMS Applicant Requirements

SPL UNCLASSIFIED SECTION

UCB, Inc. must provide training to healthcare providers who prescribe ZILBRYSQ.

The training includes the following educational materials: Healthcare Provider Safety Brochure, Patient Guide, and Patient Safety Card. The training must be available on a website and in hardcopy format via mail.

UCB, Inc. must provide training to pharmacies that dispense ZILBRYSQ.

The training includes the following educational material: Healthcare Provider Safety Brochure. The training must be available on a website and in hardcopy format via mail.

SPL UNCLASSIFIED SECTION

To inform healthcare providers about the REMS and the risks and safe use of ZILBRYSQ, UCB, Inc. must disseminate REMS communication materials according to the table below:

Target Audience

Communication Materials & Dissemination Plans

REMS certified prescribers of ZILBRYSQ

REMS Letter: Vaccination reminder to REMS certified prescribers

  1. Fax or email annually
SPL UNCLASSIFIED SECTION

To support REMS operations, UCB, Inc. must:

  1. Establish and maintain a REMS website, www.ZILBRYSQREMS.com. The REMS website must include the capability for prescribers and pharmacies to enroll in the REMS online, by fax, or by email, and the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS website. The REMS website must not link back to the promotional product website(s).
  2. Make the REMS website fully operational and all REMS materials available through the website or call center by the date ZILBRYSQ is first commercially distributed.
  3. Establish and maintain a REMS call center for REMS participants at 1-877-414-8353.
  4. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the ZILBRYSQ REMS.
  5. Ensure prescribers and pharmacies are able to enroll in the REMS by fax, email, and online.
  6. Ensure prescribers are able to report adverse events suggestive of meningococcal infection by phone.
  7. Ensure pharmacies are able to report adverse events suggestive of meningococcal infection by email.
  8. Ensure that once a report suggestive of meningococcal infection is received, UCB, Inc. will follow up with the healthcare providers to obtain all required data. This requirement does not affect UCB, Inc.’s other reporting and follow up requirements under FDA regulations.
  9. Provide the Healthcare Provider Safety Brochure, Prescriber Enrollment Form, Patient Guide, Patient Safety Card, and the Prescribing Information to prescribers who (1) attempt to prescribe ZILBRYSQ and are not yet certified or (2) inquire about how to become certified.
  10. Provide Healthcare Provider Safety Brochure and Pharmacy Enrollment Form to pharmacies that (1) attempt to order/dispense and are not yet certified or (2) inquire about how to become certified.
  11. Notify prescribers and pharmacies within 2 business days after they become certified in the REMS.
  12. Provide certified pharmacies access to a database of certified prescribers.
  13. Provide certified prescribers access to a database of certified pharmacies.
  14. Provide authorized wholesalers, distributors, and other entities that distribute ZILBRYSQ access to a database of certified pharmacies.
SPL UNCLASSIFIED SECTION

To ensure REMS participants’ compliance with the REMS, UCB, Inc. must:

  1. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: ZILBRYSQ distribution and dispensing; certification of prescribers and pharmacies; and audits of REMS participants. These records must be readily available for FDA inspections.
  2. Verify annually that the designated Authorized Representative’s name and contact information correspond to those of the current designated authorized representative for the pharmacy. If different, the pharmacy must be required to re-certify with a new Authorized Representative.
  3. Establish and maintain a plan for addressing noncompliance with REMS requirements.
  4. Monitor prescribers and pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if noncompliance is identified, including de-certification.
  5. Audit certified pharmacies no later than 180 calendar days from the date the first shipment was sent from the pharmacy, then annually thereafter, to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
  6. Audit wholesalers, distributors, and other entities that distribute ZILBRYSQ no later than 180 calendar days after their first commercial distribution of ZILBRYSQ and annually thereafter to ensure all REMS processes and procedures are in place, functioning, and comply with REMS requirements.
  7. Take reasonable steps to improve operations of and compliance with the requirements in the ZILBRYSQ REMS based on monitoring and evaluation of the ZILBRYSQ REMS.

IV. REMS Assessment Timetable

REMS Timetable for Submission Assessments

UCB, Inc. must submit REMS Assessments at 6 months, 12 months, and annually thereafter from the date of the initial approval of the REMS. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. UCB, Inc. must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS Material

The following materials are part of the ZILBRYSQ REMS.

Enrollment Forms

Prescriber:

  1. Prescriber Enrollment Form

Pharmacy:

  1. Pharmacy Enrollment Form

Training and Educational Materials

Prescriber:

  1. Healthcare Provider Safety Brochure

Patient:

  1. Patient Safety Card
  2. Patient Guide

Pharmacy:

  1. Healthcare Provider Safety Brochure

Communication Materials

  1. REMS Letter: Vaccination reminder to REMS certified prescribers

Other Materials

  1. REMS website

VI. Statutory Elements

REMS Elements

This REMS is required under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Elements to Assure Safe Use (ETASU):
    1. Health care providers who prescribe ZILBRYSQ are specially certified under 505-1(f)(3)(A)
    2. Pharmacies that dispense ZILBRYSQ are specially certified under 505-1(f)(3)(B)
    3. ZILBRYSQ is dispensed to patients with evidence or other documentation of safe-use conditions under 505-1(f)(3)(D)
  2. Implementation System
  3. Timetable for submission of Assessments

DailyMed Product Concepts#

Product concept, Relation, Version table
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d5017567-4b89-47d2-9d4f-3fe2e6641b4dProduct name120250630

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use ZILBRYSQ safely and effectively. See full prescribing information for ZILBRYSQ. ZILBRYSQ (zilucoplan) injection, for subcutaneous use Initial U.S. Approval: 2023SPL related document2026-02-03UCB, Inc.20250529_db2fcbe3-9144-485f-976c-1d555577a19b.zip!cc1a8cfa-f73f-4f3d-a4ae-906aac4a5bd1.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZILBRYSQZILUCOPLANUCB, Inc.9f1d53d6-e495-4a3a-8bb9-680a15d250342026-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZILBRYSQ

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