Plaque psoriasis is a chronic autoimmune condition that manifests as raised, red patches on the skin, often covered with silvery scales. If you are dealing with moderate to severe plaque psoriasis, it’s essential to find the right approach to manage your symptoms and improve your quality of life. This article provides important safety information about SILIQ, a prescription medicine used to treat adults with plaque psoriasis. Think of this information as guidance from a knowledgeable “Plaque Doctor,” helping you understand your treatment options and potential risks.
Important Safety Information about SILIQ
It is critical to be aware of the most significant warnings associated with SILIQ treatment.
Suicidal Thoughts and Behavior
One of the most serious concerns with SILIQ is the potential risk of suicidal thoughts and behavior. Patients taking SILIQ have, in some instances, experienced suicidal ideation and, tragically, some have died by suicide. This risk may be elevated if you have a pre-existing history of suicidal thoughts or depression. It’s crucial to understand that it is not definitively known if SILIQ directly causes these thoughts and actions, but the association is significant and warrants careful monitoring.
Immediate Action Required: If you or a family member notices any of the following symptoms, seek medical help right away or call the National Suicide and Crisis Lifeline at 988:
- New or worsening depression, anxiety, or mood disturbances.
- Thoughts of suicide, death, or self-harm.
- Attempts to commit suicide or acting on dangerous impulses.
- Any other unusual shifts in behavior or mood.
Alt text: SILIQ REMS patient wallet card highlighting symptoms requiring immediate medical attention for patients undergoing SILIQ treatment.
SILIQ REMS Program: Due to the risk of suicidal thoughts and behavior, SILIQ is exclusively available through a restricted distribution program called the SILIQ Risk Evaluation and Mitigation Strategy (REMS). This means SILIQ can only be prescribed by healthcare providers certified within this program. Your healthcare provider will provide you with a SILIQ patient/wallet card detailing symptoms that require immediate medical attention. It is vital to carry this card with you throughout your SILIQ treatment and present it to all healthcare providers you consult. SILIQ is dispensed only through pharmacies participating in the SILIQ REMS program. Your healthcare provider can offer guidance on locating a participating pharmacy. For further information, visit www.SILIQREMS.com or call 1-855-511-6135.
Serious Allergic Reactions
SILIQ can also trigger serious allergic reactions. Seek immediate medical attention if you experience any of the following signs or symptoms:
- Swelling of the face, lips, or tongue.
- Difficulty breathing or swallowing.
- Itching.
- Dizziness or feeling faint.
- Rash, hives, or redness spreading across the body.
- Chest pain or tightness.
Serious Infections
SILIQ may weaken your immune system’s ability to fight off infections, potentially increasing your risk of developing infections.
- Tuberculosis (TB) Screening: Your healthcare provider should conduct a TB test before you start SILIQ treatment. If you have TB or a history of TB, you may need to be treated for TB prior to starting SILIQ.
- Monitoring for Infection: Both you and your healthcare provider must be vigilant in watching for signs and symptoms of infection during SILIQ treatment. These can include:
- Fever, sweats, chills.
- Shortness of breath.
- Stomach problems.
- Muscle aches.
- Cough, sore throat, or difficulty swallowing.
- Warm, red, or painful skin sores.
- Burning sensation during urination or more frequent urination than usual.
Alt text: Subcutaneous injection of medication using a prefilled syringe, a common method for self-administering drugs like SILIQ for plaque psoriasis.
Who Should Not Use SILIQ?
Avoid using SILIQ if you have known allergies to brodalumab or any other components of SILIQ. SILIQ is also contraindicated if you have Crohn’s disease. Inform your healthcare provider if you develop symptoms suggestive of Crohn’s disease, such as diarrhea, bloody stools, stomach pain or cramping, sudden bowel movements, loss of appetite, constipation, weight loss, fever, or fatigue.
Before starting SILIQ, it’s crucial to inform your healthcare provider if you:
- Have a history of mental health issues, including suicidal thoughts, depression, anxiety, or mood disorders.
- Have an ongoing infection or experience recurrent infections.
- Have TB or have been in close contact with someone who has TB.
- Have recently received or are scheduled to receive any vaccinations. Live vaccines should be avoided while on SILIQ treatment.
- Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. The effects of SILIQ on unborn babies or newborns are currently unknown.
Disclose all medications you are currently taking to your healthcare provider, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
How to Use SILIQ
Refer to the detailed “Instructions for Use” provided with your SILIQ medication for comprehensive guidance on storage, preparation, and administration of SILIQ injections at home, as well as proper disposal of used prefilled syringes. Always use SILIQ exactly as instructed by your healthcare provider.
What are the Possible Side Effects of SILIQ?
SILIQ can cause serious side effects, including severe skin reactions resembling eczema. These reactions can occur during treatment, from days to months after your initial dose, and may sometimes necessitate hospitalization. Your healthcare provider might temporarily discontinue SILIQ treatment if you develop severe skin reactions. Report any of the following signs or symptoms to your healthcare provider: redness or rash, itching, small bumps or patches, dry or leathery skin, blisters on hands or feet that ooze or become crusty, or skin peeling.
Remember to review the sections “What is the most important information I should know about SILIQ?” and “Who should not take SILIQ?” for other critical safety information.
Common side effects of SILIQ include:
- Joint pain
- Headache
- Tiredness
- Diarrhea
- Mouth or throat pain
- Nausea
- Muscle pain
- Injection site reactions
- Flu-like symptoms
- Low white blood cell count (neutropenia)
- Fungal infections of the skin
Consult your doctor for medical advice regarding any side effects. You are encouraged to report any negative side effects of prescription drugs to Bausch Health at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
What is SILIQ?
SILIQ® injection is a prescription medication indicated for the treatment of adults with moderate to severe plaque psoriasis:
- Who may benefit from systemic therapy (injections or pills) or phototherapy (ultraviolet light treatment).
- Who have previously tried another systemic therapy that was ineffective or stopped working.
The safety and effectiveness of SILIQ in children have not been established.
Click here for complete Prescribing Information, including the Boxed Warning about suicidal ideation and behavior, and the Medication Guide.
Disclaimer: This information is for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare professional for diagnosis and treatment of plaque psoriasis and before starting or changing any treatment, including SILIQ.
