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The goal of the SILIQ REMS Program is to mitigate the observed risk of suicidal ideation and behavior, including completed suicides,
which occurred in subjects treated with SILIQ by:
Ensuring that prescribers are educated about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to counsel patients about this risk.
Ensuring that patients are informed about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to seek medical attention for manifestations
of suicidal thoughts and behavior,new onset or worsening depression, anxiety, or other mood changes.
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 in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS program.
Enrollment Form and submitting it to the REMS
Program.
| Prescriber Enrollment |
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.
Enroll the patient by completing and submitting the
Patient Enrollment Form to the REMS Program.
Provide a completed copy of the form to the patient.
| Patient Enrollment Form |
At all times
Report treatment discontinuation or transfer of care to
the REMS Program.
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 Program by completing the Patient
Enrollment Form with the prescriber. Enrollment
information will be provided to the REMS Program.
| Patient Enrollment Form |
Inform the prescriber if you have suicidal thoughts or
behavior, or any new or worsening symptoms of
depression, anxiety, or other mood changes.
Pharmacies that dispense SILIQ must:
To become certified to
dispense
Designate an authorized representative to carry out the
certification process and oversee implementation and
compliance with the REMS Program on behalf of the
pharmacy.
Have the authorized representative enroll in the REMS
by completing the Pharmacy Enrollment Form and
submitting it to the REMS Program.
| Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing SILIQ on
the REMS Program requirements as described on the
Pharmacy Enrollment Form.
| Pharmacy Enrollment Form |
Before dispensing
Obtain authorization to dispense each prescription by
contacting the REMS Program to verify the prescriber is
certified and the patient is enrolled.
To maintain certification to
dispense
Have a new authorized representative enroll in the
REMS program by completing and submitting the
Pharmacy Enrollment Form to the REMS.
| Pharmacy Enrollment Form |
At all times
Maintain records that all processes and procedures are
in place and being followed.
Comply with audits 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.
Train all relevant staff involved in distribution on the
REMS requirements.
At all times
Distribute only to certified pharmacies.
Maintain and submit records of all drug distribution to
the REMS Program.
Maintain records that all processes and procedures are
in place and being followed.
Comply with audits 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
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 to expand the gender categories to improve inclusivity
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.
