What is etanercept?

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.

Precautions

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.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using etanercept, tell your doctor if you have:

  • a weak immune system;
  • any type of infection including a skin infection or open sores;
  • diabetes;
  • congestive heart failure;
  • a nerve disorder such as multiple sclerosis, myelitis, or optic neuritis;
  • epilepsy or other seizure disorder;
  • asthma or other breathing disorder;
  • if you have ever had hepatitis B;
  • if you are allergic to latex rubber;
  • if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or
  • if you are scheduled to receive any vaccines.

FDA pregnancy category B. Etanercept is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether etanercept passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

Using etanercept may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in children and young adults. Talk to your doctor about your specific risk.

Do not receive a "live” vaccine while you are being treated with etanercept, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of etanercept is not expected to produce life-threatening symptoms.

Call your doctor for instructions if you miss your etanercept dose.

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Side Effects

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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Tell your doctor about all other medications you use, especially:

  • anakinra (Kineret);
  • cyclophosphamide (Cytoxan, Neosar);
  • sulfasalazine (Azulfidine); or
  • drugs that weaken your immune system (such as cancer medicine or steroids).

This list is not complete and there may be other drugs that can interact with etanercept. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Other Names

Enbrel, Enbrel SureClick, etanercept, and Enbrel Prefilled Syringe

Available Strengths & Dosages


Route Form Strength
subcutaneous solution 50 mg/mL

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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