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Indication and Important Safety Information for SILIQ (brodalumab) Injection

What is SILIQ?
SILIQ™ injection is a prescription medicine used to treat adults with moderate to severe plaque psoriasis:

who may benefit from injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light treatment)
and
who have tried another systemic therapy that didn’t work or stopped working

It is not known if SILIQ is safe and effective in children.

What is the most important information I should know about SILIQ?

Suicidal thoughts or behavior: Some patients taking SILIQ have had suicidal thoughts or ended their own lives. This risk is higher if you have a history of suicidal thoughts or depression. It is not known if SILIQ causes these thoughts or actions. Get medical help right away if you or a family member notices that you have any of the following symptoms:

new or worsening depression, anxiety, or mood problems
thoughts of suicide, dying, or hurting yourself
attempt to commit suicide, or acting on dangerous impulses
other unusual changes in your behavior or mood

Your healthcare provider will give you a SILIQ patient/wallet card about symptoms that need medical attention right away. Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers.

Serious Infections: SILIQ may lower the ability of your immune system to fight infections and may increase your risk of infections.

Your healthcare provider should check you for tuberculosis (TB) before starting treatment with SILIQ and may treat you for TB before starting SILIQ if you have TB or a history of it
You and your healthcare provider need to watch closely for signs and symptoms of infection during treatment with SILIQ, including fever, sweats, chills, shortness of breath, stomach issues, muscle aches, cough, sore throat or trouble swallowing, warm/red/painful skin sores, burning while urinating or more frequent urination

Who should not use SILIQ?
Do not use SILIQ if you have Crohn’s disease. Tell your healthcare provider if you develop diarrhea, bloody stools, stomach pain or cramping, sudden or uncontrollable bowel movements, loss of appetite, constipation, weight loss, fever or tiredness as these may be symptoms of Crohn’s disease.

Before starting SILIQ, tell your healthcare provider if you:

have a history of mental health problems, including suicidal thoughts, depression, anxiety, or mood problems
have an infection that does not go away or keeps coming back
have TB or have been in close contact with someone with TB
have recently received or are scheduled to receive an immunization (vaccine). You should avoid getting live vaccines while being treated with SILIQ
are or plan to become pregnant, or are breastfeeding or plan to do so. It is unknown if SILIQ can harm your unborn or newborn baby

How should I use SILIQ?
See the detailed “Instructions for Use” that come with your SILIQ for information on the right way to store, prepare, and give your SILIQ injections at home, and how to properly throw away (dispose of) used SILIQ prefilled syringes.

What are possible side effects of SILIQ?
SILIQ may cause serious side effects. See “What is the most important information I should know about SILIQ?” and “Who should not take SILIQ?”

The most common side effects of SILIQ include:

Joint pain
Headache
Tiredness
Diarrhea
Mouth or throat pain
Nausea

Muscle pain
Injection site reactions
Flu
Low white blood cell count (neutropenia)
Fungal infections of the skin

Call your doctor for medical advice on side effects. You are encouraged to report negative side effects of prescription drugs to FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088. Click here for full Prescribing Information, including Boxed Warning about suicidal ideation and behavior, and Medication Guide.

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Indication and Important Safety Information for SILIQ (brodalumab) Injection

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 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 in the full Prescribing Information].

Crohn’s Disease SILIQ is contraindicated in patients with Crohn’s disease. In clinical trials, which excluded Crohn’s patients, one SILIQ-treated 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.

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 for prior to initiation in patients with past history of latent TB if adequate treatment cannot be confirmed. Monitor closely for symptoms of active TB during and after treatment.

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 Valeant Pharmaceuticals 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.