Approved Risk Evaluation and Mitigation Strategies (REMS)
Siliq (brodalumab)
BLA #761032
REMS last update: 07/19/2023
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:
- 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.
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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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:
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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:
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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.