Enbrel (etanercept)

IMPORTANT SAFETY INFORMATION

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 healthcare provider 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 tumor necrosis factor (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 may be more likely to get lymphoma.

Before starting ENBREL, tell your healthcare provider if you:

What are the possible side effects of ENBREL?

ENBREL can cause serious side effects including: New infections or worsening of infections you already have; 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 and upper respiratory infections (sinus infections).

In general, side effects in children were similar in frequency and type as those seen in adult patients. The types of infections reported were generally mild and similar to those usually seen in children.

These are not all the side effects with ENBREL. Tell your healthcare provider 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 healthcare provider. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://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 moderately to severely active 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 with or without methotrexate.

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 chronic moderate to severe plaque psoriasis (PsO) in children 4 years and older and adults who may benefit from taking injections or pills (systemic therapy) or phototherapy (ultraviolet light).

IMPORTANT SAFETY INFORMATION: What is the most important information I should know about Enbrel (etanercept)?

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 healthcare provider 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 tumor necrosis factor (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 may be more likely to get lymphoma.

Before starting ENBREL, tell your healthcare provider if you:

What are the possible side effects of ENBREL?

ENBREL can cause serious side effects including: New infections or worsening of infections you already have; 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 general, side effects in children were similar in frequency and type as those seen in adult patients. The types of infections reported were generally mild and similar to those usually seen in children.

These are not all the side effects with ENBREL. Tell your healthcare provider 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 healthcare provider. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://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 moderately to severely active 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 with or without methotrexate.

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.

At Enbrel.com, you can learn about Enbrel (etanercept), a self-injected biologic medicine used to treat inflammatory diseases with long-term effects. You can find information about moderate to severe rheumatoid arthritis(RA), moderate to severe plaque psoriasis, psoriatic arthritis, moderately to severely active polyarticular juvenile idiopathic arthritis(JIA), and ankylosing spondylitis(AS). You can learn about symptoms, treatment, how Enbrel (etanercept) works for each condition, results for each condition, results for each condition, and safety information.

Enbrel.com supports you and your loved ones from diagnosis to treatment. You can find resources like injection demonstrations, patient testimonial videos, questions to ask your doctor, and even help with finding a rheumatologist or dermatologist near you.

Enbrel.com also provices ongoing assistance with ENBREL SupportTM, a patient support program to help with out-of-pocket costs and connect you with registered nurses and ENBREL Nurse Partners. The resources available will help you get started. Resources include the ENBREL Starter Kit, injection and medicine refill reminders, free needle disposal containers, travel packs, and ongoing education.

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Enbrel (etanercept)