The SILIQ REMS Program is a safety program to manage the observed risk of suicidal ideation and behavior, including completed suicides, which occurred in patients treated with SILIQ in phase 3 clinical trials.
- A causal association between treatment with SILIQ and increased risk of suicidal ideation and behavior has not been established1
- However, there were 4 completed suicides among the >4400 patients in the phase 3 clinical trials who received SILIQ. These trials did not exclude patients with history of psychiatric disorders, including depression and anxiety; approximately 18% had such a history at baseline15
The SILIQ REMS Program is therefore required by the US Food and Drug Administration (FDA) to ensure that the benefits of SILIQ outweigh its risks. Healthcare professionals who wish to prescribe SILIQ must be certified in the SILIQ REMS Program, and their patients must enroll to obtain their SILIQ prescriptions.
In the videos below, leading healthcare professionals share their insights about the SILIQ REMS Program and how they discuss this important issue with their patients.
The SILIQ REMS Process: A Worthwhile and Uncomplicated Conversation
#1: Approaching the Conversation
Featuring Mark Lebwohl, MD
Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai in New York
#2: Navigating Patient Conversations
Featuring Tina Bhutani, MD
Co-Director of the UCSF Psoriasis and Skin Treatment Center, Director of the UCSF Dermatology Clinical Research Unit
#3: Important Discussions
Featuring Scott Drew, DO
Medical and Surgical Dermatologist at Dermatology Associates of Mid Ohio
#4: An Obligation to Our Patients
Featuring Melodie Young, MSN, A/GNP-C
Nurse Practitioner at Mindful Dermatology and Modern Research Associates
For more information about the SILIQ REMS Program, or to register, download forms, or enroll patients, visit the SILIQ REMS website.
Get SILIQ certified
It’s simple. Enrolling through the REMS portal takes just a few minutes.
INDICATION
SILIQ® injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
IMPORTANT SAFETY INFORMATION
WARNING: SUICIDAL IDEATION AND BEHAVIOR
Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes [see Warnings and Precautions (5.1) in the full Prescribing Information].
Because of the observed suicidal behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program [see Warnings and Precautions (5.2) in the full Prescribing Information].
Contraindications Do not use SILIQ in patients with Crohn's disease because SILIQ may cause worsening of disease; or in patients with clinically significant hypersensitivity to brodalumab or to any of the excipients in SILIQ or components of the container.
SILIQ Risk Evaluation and Mitigation Strategy (REMS) Program SILIQ is available only through a restricted program called the SILIQ REMS because of observed suicidal ideation and behavior in patients treated with SILIQ. Before prescribing SILIQ, prescribers must be certified with the program, have each patient sign a Patient-Prescriber Agreement Form, and provide the patient a Wallet Card describing symptoms requiring immediate medical evaluation. Pharmacies must be certified and only dispense to patients authorized to receive SILIQ. More information is available at SILIQREMS.com or by calling the SILIQ REMS Program Call Center at 855-511-6135855-511-6135.
Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis requiring hospitalization, have been reported. If a serious hypersensitivity reaction occurs, immediately discontinue SILIQ and initiate appropriate therapy.
Infections SILIQ may increase the risk of infections. Serious infections and fungal infections were observed at a higher rate in patients treated with SILIQ than placebo-treated patients in clinical trials, including one case of cryptococcal meningitis that led to discontinuation of therapy.
Consider risks and benefits prior to prescribing SILIQ in patients with a chronic infection or history of recurrent infection.
Instruct patients to seek treatment if signs or symptoms of a chronic or acute infection occur.
Risk for Latent Tuberculosis (TB) Reactivation Evaluate patients for TB prior to initiating treatment with SILIQ and do not treat patients with active TB. Initiate treatment for latent TB prior to starting SILIQ and consider anti-TB therapy prior to initiation in patients with history of latent TB if adequate treatment cannot be confirmed. Monitor closely for symptoms of active TB during and after treatment.
Eczematous Eruptions Postmarketing cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, have been reported. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of SILIQ. Some cases of severe eczematous eruptions resulted in hospitalization. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing SILIQ.
Crohn’s Disease In clinical trials, which excluded Crohn’s patients, one SILIQ patient was withdrawn after developing Crohn’s disease. Discontinue SILIQ if a patient develops Crohn’s disease.
Immunizations Avoid use of live vaccines in patients treated with SILIQ.
Adverse Reactions The most commonly reported adverse reactions in clinical trials were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health at 1-800-321-4576 or the FDA at 1-800-FDA-1088, or visit www.fda.gov/medwatch.
INDICATION
SILIQ® injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
Click here for full Prescribing Information, including Boxed Warning about suicidal ideation and behavior.
Indication and Important Safety Information
Indication and Important Safety Information
SILIQ® injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to ...
IMPORTANT SAFETY INFORMATION
WARNING: SUICIDAL IDEATION AND BEHAVIOR
Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or ...
WARNING: SUICIDAL IDEATION AND BEHAVIOR
Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or ...