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Safety Information and Side Effects of ENBREL

Common side effects of ENBREL

  • The most common side effects of ENBREL are infections and injection site reactions.
  • Infections caused by viruses, fungi, or bacteria have happened in patients taking ENBREL and include the common cold, sinusitis, and the flu.
  • Injection site reactions are mild to moderate (redness, itching, pain, swelling, bleeding, and bruising) and usually go away within 3 to 5 days. If you have pain, redness, or swelling around the injection site that doesn't go away or gets worse, call your doctor.

Serious side effects of ENBREL

  • Risk of infection. ENBREL can lower the ability of your immune system to fight infections. Some people have serious infections while taking ENBREL. These infections include tuberculosis (TB), and infections caused by viruses, fungi or bacteria that spread throughout their body. Some people have died from these infections.
  • Risk of cancer.
    • There have been cases of unusual cancers in children and teenage patients who started using TNF-blocking agents at less than 18 years of age.
    • For children, teenagers, and adults taking TNF-blocker medicines, including ENBREL, the chances of getting lymphoma or other cancers may increase.
    • People with rheumatoid arthritis or psoriasis, especially those with very active disease, may be more likely to get lymphoma.
  • Previous Hepatitis B infection. If you have been previously infected with the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ENBREL.
  • Nervous system problems. Rarely, people who use TNF blocker medicines have developed nervous system problems such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes.
  • Blood problems. Low blood counts have been seen with other TNF blocker medicines. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding very easily, or looking pale.
  • Heart failure including new heart failure or worsening of heart failure you already have. New or worse heart failure can happen in people who use TNF blocker medicines, like ENBREL.
  • Psoriasis. Some people using ENBREL developed new psoriasis or worsening of psoriasis they already had.
  • Allergic reactions. Allergic reactions can happen to people who use TNF blocker medicines.
  • Autoimmune reactions, including:
    • Lupus-like syndrome. Symptoms include a rash on your face and arms that gets worse in the sun.
    • Autoimmune hepatitis. Liver problems can happen in people who use TNF blocker medicines, including ENBREL. These problems can lead to liver failure and death.

Contact your doctor right away if you begin to experience any of the above symptoms or for medical advice about side effects.

These are not all the side effects associated with ENBREL. Please see Prescribing Information, Important Safety Information, and Medication Guide for complete details about ENBREL. 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.

Prescription ENBREL is taken by injection.

IMPORTANT SAFETY INFORMATION
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.

Moderately to Severely Active 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.

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.

Ankylosing Spondylitis (AS)
ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

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.

Supportive data
Moderate to Severe Rheumatoid Arthritis (RA)
  • In medical studies, ENBREL was shown to be clinically effective in about 2 out of 3 adults with moderate to severe RA at 3 months. ENBREL has been shown to begin working in as few as 2 weeks, and most patients who benefit will do so within 3 months. In another medical study, 55% of patients who were evaluated 5 years after beginning ENBREL therapy had no further progression of joint damage.
Moderately to Severely Active Polyarticular Juvenile Idiopathic Arthritis (JIA)
  • In a clinical study, ENBREL was shown to be effective in about 3 out of 4 children with JIA who used it at 3 months. ENBREL has been shown to begin working in as few as 2 to 4 weeks.
Psoriatic Arthritis
  • ENBREL was shown to be effective in about 50% of patients at 6 months. 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 was shown to be effective in about 3 out of 5 adults at 6 months. 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
  • In medical studies, nearly half of patients saw 75% skin clearance in 3 months. Overall, 3 out of 4 patients saw 50% skin clearance in 3 months.
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