Medication Guide | Patient Instructions for Use
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ENBREL?
ENBREL is a medicine, called a tumor necrosis factor (TNF) blocker, that blocks the action of a substance your body's immune system makes, called TNF. People with immune diseases, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of active TNF in the body to normal levels, helping to treat your disease. But, in doing so, 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. Many of these serious infections occurred in people prone to infection, such as patients with advanced or poorly controlled diabetes. Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms, or have open cuts or sores, tell your doctor.
Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis. The role of TNF blockers in the development of cancer is unknown.
Tell your doctor if you:
- Think you have an infection. You should not start taking ENBREL if you have any kind of infection.
- Have any open cuts or sores
- 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 ever been diagnosed with or treated for heart failure
- Have ever had or if you develop a serious nervous system disorder
- Develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking ENBREL
Common side effects in adult clinical trials were injection site reaction, infection and headache.
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.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Prescribing Information and Medication Guide.
INDICATIONS
Moderate to Severe Rheumatoid Arthritis (RA)
ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.
- In medical studies, ENBREL was shown to be effective in about 2 out of 3 adults with RA who used it, and has been shown to begin working in as few as 2 weeks, with most patients receiving benefit within 3 months. In an RA medical study, 55% of patients had no progression of joint damage.
Moderate to Severe Polyarticular Juvenile Idiopathic Arthritis (JIA)
ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.
- In a medical study, ENBREL was shown to be effective in about 3 out of 4 children with JIA who used it. For these JIA patients, ENBREL has been shown to begin working in approximately 2 to 4 weeks.
Psoriatic Arthritis
ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
- In a medical study, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients who used it. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Ankylosing Spondylitis (AS)
ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
- In a medical study, ENBREL was shown to be effective in about 3 out of 5 adults with AS who used it. Clinical responses were seen at 2 weeks in 46% of patients, with 59% of patients receiving benefit within 8 weeks.
Moderate to Severe Plaque Psoriasis
ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- In medical studies, nearly half of patients saw a significant improvement in their plaque psoriasis within 3 months of using ENBREL. Overall, 3 out of 4 patients saw improvement. ENBREL can work fast; many patients saw improvement within 2 months. ENBREL has been shown to be effective through 12 months of therapy.
* Unless otherwise noted, the people shown on this site are models and are used for illustrative purposes only.
Important Safety Information |
Manufactured by Immunex Corporation, Thousand Oaks, CA 91320. Marketed by Amgen and Wyeth Pharmaceuticals.
© 2009 Amgen, Thousand Oaks, CA 91320 and Wyeth Pharmaceuticals Inc., Collegeville, PA 19426
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