Enbrel

This medication is used alone or in combination with an immunosuppressant (such as methotrexate) to treat certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, and ankylosing spondylitis). Some brands of this medication are also used to treat 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.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once or twice a week.

The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight. Do not change your dose without consulting your doctor.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day(s) each week.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Your doctor may give your first injection in the medical office.

If your medication has been refrigerated, leave it at room temperature for at least 15 to 30 minutes before injecting. Do not warm up this medication any other way. For example, do not heat it in the microwave or place it in hot water. Do not shake this medication. Before using, check this product visually for particles, cloudiness, or discoloration. The prefilled syringe, cartridge, or pen injector may have small white particles in the liquid. This is normal. If you see other particles, cloudiness, or discoloration, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into areas that are sore, bruised, red, or hard.

Learn how to store and discard medical supplies safely.

You may notice improvement in your condition after 1 to 2 weeks, but it may take a few months to get the full benefit of this medication. Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

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 may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist 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 right away 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 right away if you have any serious side effects, including: a rash on nose and cheeks (butterfly rash), dizziness, extreme fatigue, looking pale, hair loss, swelling of the arms/legs, unusual bruising/bleeding, severe headache, mental/mood changes, seizures, unexplained muscle weakness, numbness/tingling of the hands/feet, unsteadiness, vision changes, severe stomach/abdominal pain, persistent nausea/vomiting, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.

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 using etanercept, tell your doctor or pharmacist if you are allergic to it; or to latex or natural dry rubber (found in some forms of etanercept); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: active or recurrent infection (such as hepatitis B, HIV, tuberculosis), blood disorders (such as leukemia, anemia), weakened bone marrow, history of cancer (such as lymphoma), diabetes, heart failure, seizures, nervous system problems (such as multiple sclerosis), a certain liver problem (alcoholic hepatitis), blood vessel disorders (such as vasculitis).

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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Store unopened medication in the refrigerator away from light. Do not freeze. Some dosage forms may also be stored at room temperature for a certain time (such as up to 14 days). Consult your pharmacist or the manufacturer's package for details. If stored at room temperature, do not place this medication back in the refrigerator. Keep all medications 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.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: abatacept, interleukin-1 blockers (such as anakinra, canakinumab, rilonacept), live vaccines (such as measles, mumps, polio, rubella, typhoid, varicella, yellow fever), other medications for autoimmune disease (such as azathioprine, cyclophosphamide).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Do not share this medication with others.

Laboratory and/or medical tests (such as 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.