Because etanercept works by blocking the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. You should tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. You should be tested for tuberculosis (TB skin test or chest X-ray) before and during treatment with etanercept. See Side Effects section for symptoms of infections to watch out for, and seek immediate medical attention if you develop any of these symptoms.

The immune system is also important in preventing and controlling cancer. Though it is very unlikely to happen, there is a risk (especially in children and teenagers) of developing cancer (such as lymphoma) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor immediately if you develop symptoms such as unusual lumps/growths, swollen glands, unexplained weight loss.

This medication is used alone or in combination with an immunosuppressant (e.g., methotrexate) to treat certain types of arthritis (e.g., rheumatoid, psoriatic, and ankylosing spondylitis), as well as a skin condition called psoriasis. These conditions are caused by an overactive immune system (autoimmune disease). The immune system attacks the body's own healthy cells, causing inflammation in the joints and skin.

Etanercept controls your body's defensive response by blocking the action of a certain natural substance (TNF) that is used by the immune system. Treatment decreases redness, itching and scaly patches in psoriasis as well as the pain, swelling and stiffness of joints in arthritis. This medication can stop the progression of disease and joint damage, resulting in improved daily functioning and quality of life.

This medication treats but does not cure autoimmune diseases. Symptoms usually return within 1 month of stopping the medication.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug has also been used to treat another autoimmune disorder called Wegener's granulomatosis. It should not be used with other immunosuppressants (e.g., cyclophosphamide) for this use.

Read the Medication Guide and the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. A Medication Guide is also available from your pharmacist in the US. If you have any questions, consult your doctor or pharmacist.

Etanercept is injected under the skin of the thigh, abdomen, or upper arm, usually once or twice weekly exactly as prescribed by your doctor.

Make sure you learn the proper way to inject this medication from your health care professional, as described in the Patient Information Leaflet from the manufacturer. If you will be giving yourself the injection, your doctor may want you to have the first injection in the medical office.

Allow the medication to warm to room temperature before injecting. Do not shake the product. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site each time you use this drug to prevent problems under the skin. New injections should be given at least 1 inch (2.5 centimeters) from an old injection site. Do not inject into areas of the skin that are sore, bruised, red, or hard.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Your dosage is based on your medical condition and response to treatment. Do not change your dose without first consulting your doctor. Use this medication regularly in order to get the most benefit from it. You should start to see an improvement in 1 to 2 weeks. It may take up to 3 months to receive the full benefit of this medication.

Tell your doctor if your condition persists or worsens.

Redness, itching, pain, or swelling at the injection site may occur. This usually starts 1-2 days after the injection and clears up in 3-5 days. Injection site reactions usually lessen after the first month. Headache, nausea, vomiting and abdominal pain may occur. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you develop signs of infection while using this drug, such as: fever, chills, persistent sore throat, persistent cough, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).

Tell your doctor immediately if any of these unlikely but serious side effects occur: a rash on nose and cheeks (butterfly rash), dizziness, extreme fatigue, hair loss, severe stomach/abdominal pain, swelling of the arms/legs.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: unusual bruising or bleeding, severe headache, mental/mood changes, unexplained muscle weakness, seizures, tingling of the hands/feet, unsteadiness, vision changes, dark urine, persistent nausea/vomiting, yellowing eyes/skin.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking etanercept, tell your doctor or pharmacist if you are allergic to it; or to latex; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: active or recurrent infection (e.g., hepatitis B, tuberculosis), blood disorders (e.g., leukemia, anemia), decreased bone marrow function, history of cancer (e.g., lymphoma), cut or open sore, diabetes, heart disease (e.g., heart failure), seizures, certain brain/spinal cord disorders (e.g., multiple sclerosis).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine. Consult your doctor about risks of exposure to chickenpox and other infections.

Caution is advised when using this drug in the elderly because they may be more prone to infections.

It is recommended that children be up to date on all their childhood vaccinations before starting etanercept.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: abatacept, anakinra, live vaccines (e.g., measles, mumps, polio, rubella, typhoid, varicella, yellow fever).

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting etanercept.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other medications for autoimmune disease (e.g., azathioprine, cyclophosphamide, prednisone).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Laboratory and/or medical tests (e.g., complete blood count, liver function, TB test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

This medication may interfere with certain lab tests. Be sure to tell the lab personnel that you are on this medication.

Do not share this medication with others.

If you miss a dose, contact your doctor or pharmacist to establish a new dosing schedule.

Store unopened vials and prefilled syringes in a refrigerator between 36-46 degrees F (2-8 degrees C) away from light and moisture. Do not freeze. Once mixed, this drug must be used within 14 days and should be stored in the original vial in the refrigerator at 36-46 degrees F (2-8 degrees C). Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2009 Copyright(c) 2009 First DataBank, Inc.