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Indication and Important Safety Information

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 provider.

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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. Use SILIQ exactly as your doctor tells you to use it.

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.