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].
Crohn’s DiseaseSILIQ is contraindicated in patients with Crohn’s disease. In clinical trials, which excluded Crohn’s patients, one SILIQ patient was withdrawn after developing Crohn’s disease.
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.
InfectionsSILIQ 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) ReactivationEvaluate 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.
ImmunizationsAvoid use of live vaccines in patients treated with SILIQ.
Adverse ReactionsThe 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 Customer Service at 1-800-321-4576 or FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.
Click here for full Prescribing Information, including Boxed Warning about suicidal ideation and behavior.
*This offer is only valid for patients with commercial insurance. Patients whose commercial insurance does not cover SILIQ will pay more. These savings offers are not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B and D Plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. Click here for full eligibility terms and conditions.
References: 1. SILIQ [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC. 2. Blauvelt A, Papp KA, Lebwohl MG, et al. Rapid onset of action in patients with moderate-to-sever psoriasis treated with brodalumab: A pooled analysis of data from two phase 3 randomized clinical trials (AMAGINE-2 and AMAGINE-3). J AM Acad Dermatol. 2017;77(2):374. 3. Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318-1328. 4. Papp KA, Reich K, Paul C, et al. A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2016;175(2):273-286. 5. Data on file. Bausch Health US, LLC; Bridgewater, NJ.