ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body makes called TNF. Tumor necrosis factor is made by your body's immune system. People with immune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis have too much TNF in their bodies.
What is the most important information I should know about ENBREL?
ENBREL is a medicine that affects your immune system. ENBREL can lower the ability of your immune system to fight infections. Serious infections have happened in patients taking ENBREL. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections. Your doctor should test you for TB before you take ENBREL and monitor you closely for TB while on ENBREL.
Before starting ENBREL, tell your doctor if you:
Think you have, are being treated for, have signs of, or are prone to infection. You should not start taking ENBREL if you have any kind of infection.
Have any open cuts or sores
Have diabetes or an immune system problem
Have TB or have been in close contact with someone who has had TB
Were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure.
Live or have lived in certain parts of the country (such as, the Ohio and Mississippi River valleys, or the Southwest) where there is a greater risk for certain kinds of fungal infections, such as histoplasmosis. These infections may develop or become more severe if you take ENBREL. If you don't know if histoplasmosis or other fungal infections are common in the areas where you live or have lived, ask your doctor.
Have or have had hepatitis B
Have heart failure
Develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking ENBREL
Use the medicine Kineret® (anakinra)
Have or develop a serious nervous disorder, seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis
Are scheduled to have surgery
Are scheduled for any vaccines. All vaccines should be brought up-to-date before starting ENBREL. Patients taking ENBREL should not receive live vaccines.
Are allergic to rubber or latex
Are pregnant, planning to become pregnant, or breastfeeding
Directions:
See the Patient Instructions for Use that come with your ENBREL product for complete instructions.
Side Effects:Serious side effects include: serious infections including TB; nervous system problems, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes; rare reports of serious blood problems (some fatal); heart failure, including new heart failure or worsening of heart failure you already have; allergic reactions; immune reactions, including a lupus-like syndrome and lymphoma (a type of cancer). People with rheumatoid arthritis and psoriasis may have a higher chance for getting lymphoma.
Common side effects include: Injection site reaction, upper respiratory infections (including sinus infection), and headaches.
In a medical study of patients with JIA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults. The kinds of infections reported were generally mild and similar to those usually seen in children. Other serious adverse reactions were reported, including serious infection and depression/personality disorder.
