Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Siliq (brodalumab)
BLA #761032
REMS last update: 01/26/2018



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 See Disclaimer page regarding links to external sites

Health Care Providers who prescribe Siliq must

To become certified to prescribe
  • Review the drug’s Prescribing Information.
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
Before treatment initiation
  • Counsel the patient on suicidal ideation and behavior (SIB), including that completed suicides have occurred in patients taking Siliq; SIB events and symptoms may occur at any time during treatment with Siliq; and to be aware of symptoms of SIB events and steps to take if SIB symptoms occur.
  • Provide the patient with the Patient Wallet Card.
    | Patient Wallet Card |
  • Enroll the patient by completing and submitting the Patient-Prescriber Agreement Form to the REMS Program. Provide the bottom portion of the completed form to the patient. Retain the top portion of the completed form in the patient’s record.
At all times
  • Report if an enrolled patient has discontinued therapy or is no longer under your care to the REMS Program.

Patients who are prescribed Siliq

Before the first prescription
  • Enroll in the REMS Program by completing the Patient-Prescriber Agreement Form with the prescriber. Enrollment information will be provided to the REMS Program.
  • Receive counseling from the prescriber on the observed risk of suicidal ideation and behavior (SIB), the importance of keeping the Patient Wallet Card with them at all times, and the need to seek medical attention should they experience emergence or worsening of suicidal ideation and behavior.
    | Patient Wallet Card |
  • Receive the Patient Wallet Card and the bottom portion of the completed Patient-Prescriber Agreement Form.
    | Patient Wallet Card |

Pharmacies that dispense Siliq must

To become certified to dispense
  • Train all relevant staff involved in dispensing on the REMS Program requirements.
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form.
    | Pharmacy Enrollment Form |
Before dispensing
  • Obtain authorization to dispense each prescription by calling the REMS Program or by accessing the REMS Program Website to verify prescriber certification and patient enrollment.
To maintain certification to dispense, if the pharmacy designates a new authorized representative
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form.
At all times
  • Maintain records of documentation that all processes and procedures are in place and are being followed and provide upon request to Valeant, FDA, or a third party acting on behalf of Valeant or FDA.
  • Comply with audits carried out by Valeant, FDA, or a third party acting on behalf of Valeant or FDA to ensure that all processes and procedures are in place and are being followed.

Wholesalers that distribute Siliq must

To be able to distribute Siliq
  • Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
  • Train all relevant staff involved in distributing on REMS Program requirements.
At all times
  • Maintain records of distribution data of all shipments and documentation to support that all processes and procedures are in place and being followed, and make the documentation available for audits.
  • Comply with audits carried out by Valeant, FDA, or a third party acting on behalf of Valeant or FDA 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).
Material Name Material Name Link
Patient Wallet Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_Patient_Wallet_Card.pdf
Patient-Prescriber Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_Patient_Prescriber_Agreement_Form.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_Prescriber_Enrollment_Form.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_REMS_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2018_01_26_REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
01/26/2018

The REMS document, Prescriber Enrollment Form, REMS website, and REMS supporting document modified to reflect the following changes:

  1. Enable pharmacy staff members to associate with a certified pharmacy
  2. Allow for patient access to the list of certified prescribers via the REMS website
  3. Clarify product quantity unit of measurement
  4. 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.

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