What is the Siliq REMS Program?
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the FDA can require for medications with serious safety concerns, to ensure that the benefits of the medication outweigh its risks. The goal of the Siliq REMS Program is to manage the risk of suicidal ideation and behavior which occurred in some patients who were treated with Siliq during clinical trials.
What is Siliq?
Siliq (brodalumab) is a human interleukin-17 receptor A (IL-17RA) antagonist used for the treatment of adults with moderate to severe plaque psoriasis. It is used in patients who may benefit from systemic therapy (such as an injection) or phototherapy (ultraviolet light treatment), and who have not responded or lost response to other systemic therapy.
Siliq is administered as a subcutaneous injection at Weeks 0, 1, and 2, and then every 2 weeks.
What is the risk associated with Siliq?
Because of the risk of suicidal ideation and behavior, the Siliq product label includes a Boxed Warning, and the drug is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Siliq REMS Program.
- Doctors who prescribe Siliq should weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior.
- Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical help right away should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety or other mood changes.
- Pharmacies must be certified with the program and must only dispense Siliq to patients who are authorized to receive it.
It is not known if Siliq causes suicidal thoughts or behavior, but the risk is higher in patients who have a history of suicidal thoughts or depression. Patients with new or worsening suicidal thoughts and behavior should get medical help right away if they notice any of the following symptoms:
- new or worsening depression or anxiety
- thoughts of suicide, dying, or hurting yourself
- changes in behavior or mood
- acting on dangerous impulses
- attempt to commit suicide
Patients who are prescribed Siliq will need to carry a Siliq Patient Wallet Card which lists which symptoms that require immediate medical help. The card must be carried at all times and needs to be shown to all healthcare providers.
- U.S. Food and Drug Administration. Risk Evaluation and Mitigation Strategies | REMS. Available at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems [Accessed April 8, 2021]
- U.S. Food and Drug Administration. Siliq Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf [Accessed April 8, 2021]
- SILIQ REMS Available at https://siliqrems.com/SiliqUI/home.u [Accessed April 8, 2021]
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- Siliq Information for Consumers
- Siliq Information for Healthcare Professionals (includes dosage details)
- Side Effects of Siliq (detailed)
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