Generic Name: brodalumab
Dosage Form: Injection
Date of Approval: February 15, 2017
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Plaque Psoriasis
FDA Approves Siliq
The U.S. Food and Drug Administration (FDA) has approved Siliq (brodalumab) injection, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis.
Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
Siliq may cause serious side effects, including:
- Suicidal thoughts or behavior have happened in some people treated with Siliq. Some people have ended their own lives. Your risk of suicidal thoughts and behavior may be increased if you have a history of suicidal thoughts or depression. It is not known if Siliq causes suicidal thoughts or behavior. Get medical help right away if you or your caregiver notice any of the following symptoms:
- new or worsening depression or anxiety
- thoughts of suicide, dying, or hurting yourself
- changes in behavior or mood
- acting on dangerous impulses
- attempt to commit suicide
- Serious infections. Siliq may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider will check you for tuberculosis (TB) before starting treatment, and may treat you for TB before you begin treatment if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of infection and TB during and after treatment.
Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
- fever, sweats, or chills
- muscle aches
- shortness of breath
- sore throat or difficulty swallowing
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more often than normal
What is Siliq?
Siliq is a prescription medicine used to treat adults with moderate to severe plaque psoriasis:
- who may benefit from taking injections or pills (systemic therapy) or phototherapy (ultraviolet light treatment), and
- who have not responded or lost response to other systemic therapy
It is not known if this medicine is safe and effective in children.
Do not use this medicine if you have Crohn’s disease.
Before you use Siliq
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of mental problems, including suicidal thoughts, depression, anxiety, or mood problems.
- have an infection that does not go away or that 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 receiving live vaccines during your treatment.
- are pregnant or plan to become pregnant. It is not known if this medicine can harm your unborn baby. If you are pregnant or plan on becoming pregnant, consult with your healthcare provider.
- are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.
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 comes with your prescription for information on how to inject a dose and how to properly store and throw away (dispose of) the used prefilled syringes.
- Use this medicine exactly as your healthcare provider tells you to use it.
- Your healthcare provider may stop your treatment if your plaque psoriasis does not improve within 12 to 16 weeks.
Siliq side effects
Siliq may cause serious side effects. See Important information.
- Crohn’s disease. Tell your healthcare provider if you develop diarrhea, painful diarrhea, bloody stools, stomach pain or cramping, sudden or uncontrollable bowel movements, loss of appetite, constipation, weight loss, fever, or tiredness.
The most common side effects include: joint pain, headache, tiredness, diarrhea, mouth or throat pain, nausea, muscle pain, injection site reactions, flu (influenza), low white blood count (neutropenia), and fungal infections of the skin.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about safe and effective use of Siliq
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.