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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 in the REMS by completing the Prescriber Enrollment Form
and submitting it to the REMS.
Before treatment initiation (first
dose)
Counsel the patient on the risk of suicidal ideation and behavior
including that completed suicides have occurred with patients
treated with SILIQ, symptoms may occur at any time during
treatment, the need to seek medical attention for suicidal
thoughts and behavior, new onset or worsening symptoms of
depression, anxiety, or other mood changes, and the importance
of keeping the Patient Wallet Card with them at all times.
Provide the patient with the Patient Wallet Card.
Enroll the patient by completing and submitting the
Patient Enrollment Form to the REMS. Provide a completed copy
of the form to the patient.
At all times
Report treatment discontinuation or transfer of care to the
REMS.
Patients who are prescribed SILIQ:
Before treatment initiation
Receive counseling from the prescriber on the risk of suicidal
ideation and behavior including that completed suicides have
occurred with patients treated with SILIQ, symptoms may occur
at any time during treatment, the need to seek medical
attention for suicidal thoughts and behavior, new onset or
worsening symptoms of depression, anxiety, or other mood
changes, and the importance of keeping the Patient Wallet Card
with you at all times.
Enroll in the REMS by completing the Patient Enrollment Form
with the prescriber. Enrollment information will be provided to
the REMS.
Receive the Patient Wallet Card.
At all times
Have the Patient Wallet Card with you.
Inform the prescriber if you have suicidal thoughts or behavior,
or any new or worsening symptoms of depression, anxiety, or
other mood changes.
Pharmacies and prescribers that dispense SILIQ must:
To become certified to dispense
For pharmacies: Designate an authorized representative to
carry out the certification process and oversee implementation
and compliance with the REMS on behalf of the pharmacy.
For pharmacies: Have the authorized representative enroll in
the REMS by completing the Pharmacy Enrollment Form and
submitting it to the REMS.
For pharmacies: Train all relevant staff involved in dispensing
SILIQ on the REMS requirements as described on the Pharmacy
Enrollment Form.
For prescribers who dispense: Complete the certified dispenser
section of the Prescriber Enrollment Form.
Before dispensing
For pharmacies: Obtain authorization to dispense each
prescription by contacting the REMS to verify the prescriber is
certified and the patient is enrolled.
For prescribers who dispense: Report dispensing to the REMS
using the Patient Enrollment Form.
To maintain certification to
dispense
For pharmacies: Have a new authorized representative enroll in
the REMS by completing and submitting the Pharmacy
Enrollment Form to the REMS.
At all times
Maintain records that all processes and procedures are in place
and being followed.
Comply with audits carried out by Bausch Health US, LLC or
third party acting on behalf of Bausch Health US, LLC to ensure
that all processes and procedures are in place and are being
followed.
Wholesalers-distributors that distribute SILIQ must:
To be able to distribute
Establish processes and procedures to ensure that the drug is
distributed only to certified pharmacies and certified prescribers
who dispense.
Train all relevant staff involved in distribution on the REMS
requirements.
At all times
Distribute only to certified pharmacies and certified prescribers
who dispense.
Maintain and submit records of all drug distribution to the
REMS.
Maintain records that all processes and procedures are in place
and being followed.
Comply with audits carried out by Bausch Health US, LLC or a
third party acting on behalf of Bausch Health US, LLC to ensure
that 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. For a specific Medication Guide of a product in the Siliq REMS, see the DailyMed link(s).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters,
and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
05/07/2026
Modified to update the REMS Website to
indicate in the patient profile if a sample dose was dispensed.
02/27/2026
Modified to consist of changes to incorporate requirements for participants who dispense or distribute Siliq samples (i.e., healthcare providers who dispense and distributors).
01/16/2024
Revised to reflect editorial changes to the contact information on the REMS website
07/19/2023
Modified REMS materials to update the National Suicide Prevention Lifeline phone
number and make editorial changes to the website screenshots.
06/14/2022
Modified to update formatting and functionality of the REMS website becauase of a change in the REMS administrator.
01/22/2021
Modified to reflect the following:
Conversion of the REMS Document to the new, standardized format
Removal of the word “Program” from the titles of the REMS materials to reflect current practice on naming
Changes to the Stakeholder Enrollment Form instructions to improve clarity and removal of the DEA field as brodalumab is not a controlled substance
Changes to the Patient Enrollment Form
Changes to the REMS materials to align with changes to the REMS Document
12/13/2019
Revised to reflect editorial changes.
06/27/2019
Revised to reflect the new company name.
10/09/2018
Modified to remove the Website Consent section of the SILIQ REMS Program Prescriber Enrollment Form by which prescribers authorize the publishing of their information on the REMS website, and removal of the listing of
certified prescribers from the REMS website.
01/26/2018
The REMS document, Prescriber Enrollment Form, REMS website, and REMS supporting document modified to reflect the
following changes:
Enable pharmacy staff members to associate with a certified pharmacy
Allow for patient access to the list of certified prescribers via the REMS website
Clarify product quantity unit of measurement
Provide a link on the REMS website to Spanish-language versions of the Patient
Prescriber Agreement (PPA) Form and Patient Wallet Card.
06/08/2017
Modified to make editorial changes to the REMS document and Patient-Prescriber Agreement Form; and corrections and clarifications for the REMS website content.
02/15/2017
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.
