For: Plaque Psoriasis
Siliq (brodalumab) is a human anti-interleukin-17-receptor monoclonal antibody for the treatment of plaque psoriasis. These highlights do not include all the information needed to use SILIQ safely and effectively. See full prescribing information for SILIQ.
SILIQ™ (brodalumab) injection, for subcutaneous use
Initial U.S. Approval: 2017
WARNING: SUICIDAL IDEATION AND BEHAVIOR
See full prescribing information for complete boxed warning.
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Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. (5.1, 6.1)
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Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. (5.1)
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Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional, as appropriate. (5.1)
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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. (5.1)
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SILIQ is available only through a restricted program called the SILIQ REMS Program. (5.2)
INDICATIONS AND USAGE
SILIQ is a human interleukin-17 receptor A (IL-17RA) antagonist 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. (1)
DOSAGE AND ADMINISTRATION
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Administer 210 mg of SILIQ by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks. (2.1)
DOSAGE FORMS AND STRENGTHS
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Injection: 210 mg/1.5 mL solution in a single-dose prefilled syringe. (3)
CONTRAINDICATIONS
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Crohn’s disease (4)
WARNINGS AND PRECAUTIONS
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Infections: Serious infections have occurred. Consider the risks and benefits prior to initiating SILIQ in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue SILIQ until the infection resolves. (5.3)
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Tuberculosis (TB): Evaluate patients for TB infection prior to initiating treatment with SILIQ. (5.4)
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Crohn’s Disease: Crohn’s disease occurred during clinical trials. Discontinue SILIQ if patient develops Crohn’s disease while taking SILIQ. (5.5)
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Immunizations: Avoid using live vaccines concurrently with SILIQ. (5.5)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥1%) were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 5/2018