Important Safety Information
What is the most important information I should know about SILIQ?
What is the most important information I should know about SILIQ?
Suicidal thoughts and 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 and actions. Get medical help right away or call the National Suicide and Crisis Lifeline at 988, 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
Because of your risk of suicidal thoughts and behavior during your treatment with SILIQ, SILIQ is available only through a restricted distribution program called the SILIQ Risk Evaluation and Mitigation Strategy (REMS). SILIQ can only be prescribed by a healthcare provider certified with the program. 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. SILIQ is only available through pharmacies that participate in the SILIQ REMS. Your healthcare provider can give you information about how to find a participating pharmacy. For more information, go to www.SILIQREMS.com or call 1-855-511-6135.
Serious Allergic Reactions Get medical help right away if you get any of the following signs or symptoms of a serious allergic reaction including swelling of the face, lips, or tongue, trouble breathing or swallowing, itching, dizziness or feel faint, rash, hives, or redness all over your body, chest pain or tightness.
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 than normal
Who should not use SILIQ?
Do not use SILIQ if you are allergic to brodalumab or any of the ingredients in SILIQ or 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 healthcare provider tells you to use it.
What are possible side effects of SILIQ?
SILIQ may cause serious side effects including severe skin reactions that look like eczema. These reactions can happen during treatment with SILIQ from days to months after your first dose and can sometimes lead to hospitalization. Your healthcare provider may temporarily stop treatment with SILIQ if you develop severe skin reactions. Tell your healthcare provider if you have any of the following signs or symptoms: redness or rash; itching; small bumps or patches; your skin is dry or feels like leather; blisters on the hands or feet that ooze or become crusty or skin peeling.
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 count (neutropenia), and 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 Bausch Health at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
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.
Click here for full Prescribing Information, including Boxed Warning about suicidal ideation and behavior, and Medication Guide.
