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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 before, during, and after ENBREL treatment, even if you
have tested negative for TB.
There have been some cases of unusual cancers reported in children and teenage
patients who started using TNF blockers before 18 years of age. Also, for children,
teenagers, and adults taking TNF blockers, including ENBREL, the chances of getting
lymphoma or other cancers may increase. Patients with RA and psoriasis may be more
likely to get lymphoma.
Before starting ENBREL, tell your doctor if you:
- Have any existing medical conditions
- Are taking any medicines, including herbals
- 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, unless
your doctor says it is okay
- 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), Orencia® (abatacept), or Cytoxan®
(cyclophosphamide)
- 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
- Have recently received or 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
- Have been around someone with chicken pox
What are the possible side effects of ENBREL?
ENBREL can cause serious side effects including: Infections, including serious
infections like TB; hepatitis B can become active if you already have had it; nervous
system problems, such as multiple sclerosis, seizures, or inflammation of the nerves of
the eyes; blood problems (some fatal); new or worsening heart failure; new or
worsening psoriasis; allergic reactions; autoimmune reactions, including a lupus-like
syndrome and autoimmune hepatitis.
Common side effects include: Injection site reactions, upper respiratory infections
(sinus infections), 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.
These are not all the side effects with ENBREL. Tell your doctor about any side effect
that bothers you or does not go away.
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.
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