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Enbrel Multiple-Use Vials is used for:

Treating moderate to severe forms of rheumatoid arthritis and psoriatic arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, and psoriasis. Enbrel Multiple-Use Vials may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Enbrel Multiple-Use Vials is a type of protein called a tumor necrosis factor (TNF) inhibitor. It works by blocking the action of TNF, a substance in the body that causes swelling and painful, swollen joints and raised, thick, red, scaly patches on the skin.

Do NOT use Enbrel Multiple-Use Vials if:

• you are allergic to any ingredient in Enbrel Multiple-Use Vials
• you have an infection that has spread throughout your entire body (sepsis)
• you have Wegener's granulomatosis and are taking a medicine that may weaken the immune system (eg, methotrexate, corticosteroids)
• you are taking cyclophosphamide

Contact your doctor or health care provider right away if any of these apply to you.

Before using Enbrel Multiple-Use Vials :

Some medical conditions may interact with Enbrel Multiple-Use Vials . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have any kind of infection, including an infection that is in only one place in your body (such as an open sore), or an infection that is in your whole body (such as the flu)
• if you have a history of infections that keep coming back or other conditions (eg, diabetes) that may increase your risk of infections
• if you have tuberculosis (TB) or if you have been in close contact with someone who has had TB
• if you have any numbness or tingling or a disease that affects your nervous system (eg, multiple sclerosis [MS])
• if you have congestive heart failure, a blood disease, any lupus-like disease, rectal bleeding, shingles (herpes zoster), or Wegener's granulomatosis
• if you are scheduled to have major surgery or any kind of vaccination

Some MEDICINES MAY INTERACT with Enbrel Multiple-Use Vials . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Costimulation modulators (eg, abatacept) or interleukin-1 receptor antagonists (eg, anakinra) because the risk of getting a serious infection may be increased
• Cyclophosphamide because the risk of developing cancer may be increased
• Amphetamines (eg, dextroamphetamine), lithium, salicylates (eg, aspirin), sulfonylureas (eg, glipizide), or a decongestant (eg, pseudoephedrine) because additional monitoring of your dose or condition may be necessary

This may not be a complete list of all interactions that may occur. Ask your health care provider if Enbrel Multiple-Use Vials may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Enbrel Multiple-Use Vials :

Use Enbrel Multiple-Use Vials as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Enbrel Multiple-Use Vials . Talk to your pharmacist if you have questions about this information.
• If you will be using Enbrel Multiple-Use Vials at home, a health care provider will teach you how to use it. Be sure you understand how to use Enbrel Multiple-Use Vials . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Wash your hands with soap and warm water before using Enbrel Multiple-Use Vials .
• The dose tray containing the vials of powder must be refrigerated. Do not freeze.
• Use an alcohol swab to clean the gray stopper on the vial. Do not touch the stopper with your hands.
• Do not shake Enbrel Multiple-Use Vials .
• Do not use Enbrel Multiple-Use Vials if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• If all the powder in the vial is not dissolved or there are particles present after 10 minutes, do not inject and contact your health care provider.
• The syringe, needles, and vial adapter should never be reused. Never recap a needle.
• Rotate the site for each injection. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, try not to inject directly into any raised, red, thick, or scaly skin patches.
• You may see improvement of your symptoms as soon as 1 to 2 weeks after starting Enbrel Multiple-Use Vials . Up to 3 months of treatment may be needed for some patients.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• Do not miss any doses of Enbrel Multiple-Use Vials . If you miss a dose of Enbrel Multiple-Use Vials , contact your doctor to find out when to take your next dose.

Ask your health care provider any questions you may have about how to use Enbrel Multiple-Use Vials .

Important safety information:

• Enbrel Multiple-Use Vials may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Enbrel Multiple-Use Vials with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Enbrel Multiple-Use Vials may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Enbrel Multiple-Use Vials may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Contact your doctor if you come into contact with these infections.
• Before you use Enbrel Multiple-Use Vials , discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Enbrel Multiple-Use Vials . Talk with your doctor before you receive any vaccine.
• It may take several weeks for Enbrel Multiple-Use Vials to work. Do not stop using Enbrel Multiple-Use Vials without checking with your doctor.
• Tell your doctor or dentist that you take Enbrel Multiple-Use Vials before you receive any medical or dental care, emergency care, or surgery.
• If you develop any of the symptoms of TB (a dry cough that does not go away, weight loss, fever, night sweats), call your doctor. You will need to be examined for TB and have a skin test.
• Tell your doctor if you are allergic to rubber or latex.
• Use Enbrel Multiple-Use Vials with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of developing infections.
• Enbrel Multiple-Use Vials should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Enbrel Multiple-Use Vials while you are pregnant. It is not known if Enbrel Multiple-Use Vials is found in breast milk. Do not breast-feed while using Enbrel Multiple-Use Vials .

Possible side effects of Enbrel Multiple-Use Vials :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; pain, redness, itching, bruising or swelling around the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); butterfly rash (rash on nose and cheeks); dizziness; fever; mental or mood changes; numbness or tingling throughout your body; rash on your face and arms that gets worse in the sun; seizures; serious infection (bleeding, bruising, pale skin, persistent fever); swelling of arms or legs; unusual lumps; unusual tiredness; upper respiratory tract infection; vision problems; weakness in arms or legs.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store the unmixed medicine in its dose tray in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze.

The mixed medicine may be stored in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C) for up to 14 days. Do not freeze. Discard mixed solution after 14 days. Keep Enbrel Multiple-Use Vials out of the reach of children and away from pets.

General information:

• If you have any questions about Enbrel Multiple-Use Vials , please talk with your doctor, pharmacist, or other health care provider.
• Enbrel Multiple-Use Vials is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Enbrel Multiple-Use Vials . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.