Approved Risk Evaluation and Mitigation Strategies (REMS)

Siliq (brodalumab)

BLA #761032

REMS last update: 07/19/2023

• View the Siliq Prescribing Information and Medication Guide at DailyMed.
• View Siliq's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

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:

1. 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.
2. 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.

View application holder(s) REMS Website

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

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.