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Brand Names: Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick

Generic Name: etanercept (Pronunciation: ee TAN er sept)

• What is etanercept (Enbrel)?
• What are the possible side effects of etanercept (Enbrel)?
• What is the most important information I should know about etanercept (Enbrel)?
• What should I discuss with my healthcare provider before using etanercept (Enbrel)?
• How should I use etanercept (Enbrel)?
• What happens if I miss a dose (Enbrel)?
• What happens if I overdose (Enbrel)?
• What should I avoid while using etanercept (Enbrel)?
• What other drugs will affect etanercept (Enbrel)?
• Where can I get more information?

What is etanercept (Enbrel)?

Etanercept works by decreasing a certain protein produced by the immune system. The immune system helps the body fight infections. In people with autoimmune disorders, the immune system mistakes the body's own cells for invaders and attacks them.

Etanercept is used to treat the symptoms of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, and to prevent joint damage caused by these conditions. It is also used to treat plaque psoriasis in adults and polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.

Etanercept is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Etanercept may also be used for other purposes not listed in this medication guide.

What are the possible side effects of etanercept (Enbrel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with etanercept. Stop using etanercept and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;
• feeling short of breath;
• cough, sore throat; or
• flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• shortness of breath with swelling, rapid weight gain;
• chest pain, ongoing cough, coughing up blood;
• easy bruising or bleeding, pale skin, unusual weakness;
• signs of skin infection such as itching, swelling, warmth, redness, or oozing;
• black, bloody, or tarry stools;
• changes in mood or personality (in children);
• numbness, burning, pain, or tingly feeling;
• joint pain or swelling with fever, swollen glands, muscle aches, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
• patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious side effects may include:

• nausea, vomiting, diarrhea, stomach pain;
• runny or stuffy nose, cold symptoms; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about etanercept (Enbrel)?

You should not use this medication if you are allergic to etanercept, or if you have a severe infection such as sepsis (infection of the blood).

Before using etanercept, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Children using this medication should be current on all childhood immunizations before starting treatment with etanercept.

You may have pain, redness, swelling, or warmth where the medicine was injected. Call your doctor if these symptoms continue for longer than 5 days.

Serious and sometimes fatal infections may occur during treatment with etanercept. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.