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.
Important information
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
Your healthcare provider will give you a Siliq Patient Wallet Card about symptoms you should get medical help for right away. Carry the card with you at all times during treatment 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 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
cough
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
See Siliq side effects for more information about side effects.
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.
Siliq side effects
Siliq may cause serious side effects. See Important information.
Crohns 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.
Source: drugs.com
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