Etanercept (Enbrel) is a TNF blocker used to treat plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or polyarticular juvenile idiopathic arthritis in specific patients. Etanercept works by decreasing tumor necrosis factor (TNF), a protein produced by the immune system to help the body fight infections. In people with autoimmune disorders, the immune system produces too much TNF and mistakenly attacks healthy cells.

Etanercept is FDA-approved to treat specific types of:

• plaque psoriasis in patients 4 years and older
• rheumatoid arthritis
• psoriatic arthritis
• ankylosing spondylitis
• polyarticular juvenile idiopathic arthritis in patients 2 years or older.

Etanercept became an FDA-approved medicine on November 2, 1998.

Using etanercept may increase your risk of developing certain types of cancer, including a rare type of lymphoma. Ask your doctor about your specific risk. This has occurred mainly in teenagers and young adults using etanercept or similar medicines to treat Crohn's disease or ulcerative colitis. Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Etanercept can weaken your immune system. Serious and sometimes fatal infections may occur. Call your doctor right away if you have signs of infection such as fever, chills, cough, sweating, body aches, skin sores or redness, diarrhea, burning when you urinate, or feeling very tired or short of breath.

Before you start treatment with etanercept, your doctor may perform tests to make sure you do not have an infection.

Etanercept is injected under the skin (subcutaneous injection). A healthcare provider may teach you how to use the medication by yourself properly. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Do not shake this medicine. Prepare an injection only when you are ready to give it. Do not use it if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

You may need to mix etanercept with a liquid (diluent). When using injections by yourself, be sure you understand how to mix and store the medicine properly.

Etanercept doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

If you need surgery, tell the surgeon ahead of time that you are using this medicine

Etanercept affects your immune system, and so you may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

If you've ever had hepatitis B, using etanercept can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

Each cartridge, injection pen, or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual adult etanercept dose for rheumatoid arthritis (RA)  Ankylosing Spondylitis (AS), or psoriatic arthritis (PsA)

Dose: 50 mg once weekly with or without methotrexate.

Comments:

• Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during therapy with this drug.
• Doses higher than 50 mg per week are not recommended.

Uses:

• Rheumatoid arthritis: To reduce symptoms, induce major clinical response, inhibit the progression of structural damage, and improve physical function in patients with moderately to severely active RA; this drug can be used alone or in combination with methotrexate.
• Ankylosing spondylitis: To reduce symptoms in patients with active AS.
• Psoriatic arthritis: To reduce symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with PsA; this drug can be used alone or in combination with methotrexate.

Usual Pediatric etanercept Dose for Juvenile Idiopathic Arthritis:

Dose: 2 years and older:

• Less than 63 kg: 0.8 mg/kg subcutaneously once a week.
• Greater than or equal to 63 kg: 50 mg subcutaneously once a week.
• Maximum dose: 50 mg subcutaneously once a week.

Comments:

• Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.

Use: For reducing symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years and older.

Usual Pediatric etanercept Dose for Plaque Psoriasis:

Dose: 4 years and older:

• Less than 63 kg: 0.8 mg/kg subcutaneously once a week.
• Greater than or equal to 63 kg: 50 mg subcutaneously once a week.
• Maximum: 50 mg subcutaneously once a week.

Comments:

• Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.

Use: For the treatment of patients 4 years and older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

You should not use etanercept if you are allergic to it or if you have a severe infection such as sepsis (infection throughout your body).

To make sure etanercept is safe for you, tell your doctor if you have:

• a weak immune system, HIV or AIDS, tuberculosis, or any type of recurring infection;
• symptoms of an active infection such as fever, flu symptoms, diarrhea, or painful urination;
• an open cut or skin sores;
• diabetes;
• congestive heart failure;
• a history of nerve disorders such as multiple sclerosis, Guillain-Barré syndrome, 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; or
• if you are scheduled to receive any vaccines, or if you have recently been vaccinated with BCG (Bacille Calmette-Guerin).

Tell your doctor if you have ever had tuberculosis, were exposed to tuberculosis indicated by a positive PPD test, if anyone in your household has tuberculosis, or if you have recently traveled to an area where certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).

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

Using etanercept may increase your risk of developing certain types of cancer, including a fast-growing lymphoma that can be fatal. This rare lymphoma has occurred in male teenagers and young men using a combination of immunosuppressant medicines to treat Crohn's disease or ulcerative colitis. However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

Pregnancy

 Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of etanercept on the baby.

Breastfeeding

Etanercept can pass into breast milk and may harm a nursing baby. You should not breastfeed while using this medicine.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Do not receive a "live" vaccine while using etanercept. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, one form of typhoid, yellow fever, varicella (chickenpox), the older form of the shingles vaccine, and nasal flu (influenza) vaccine.

Common Etanercept side effects

• pain, swelling, itching, or redness where the medicine was injected;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

Serious Etanercept side effects

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

Serious and sometimes fatal infections may occur. Call your doctor right away if you have signs of infection such as fever, chills, cough, sweating, body aches, skin sores or redness, diarrhea, weight loss, burning when you urinate, coughing up blood, or feeling very tired or short of breath.

Also call your doctor at once if you have:

• fever, chills, flu symptoms;
• pale skin, easy bruising or bleeding;
• pain, redness, or swelling where etanercept was injected (for longer than 5 days after injection);
• signs of lymphoma - fever, night sweats, weight loss, stomach pain or swelling, swollen glands (in your neck, armpits, or groin);
• signs of tuberculosis - cough, night sweats, loss of appetite, weight loss, feeling very tired;
• new or worsening psoriasis - skin redness or scaly patches, raised bumps filled with pus;
• nerve problems - dizziness, numbness or tingling, problems with vision, or weak feeling in your arms or legs;
• signs of heart failure - shortness of breath, swelling in your lower legs;
• lupus-like syndrome - joint pain or swelling, chest discomfort, feeling short of breath, skin rash on your cheeks or arms (worsens in sunlight); or
• liver problems - right-sided upper stomach pain, vomiting, tiredness, loss of appetite, yellowing of your skin or eyes.

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 the FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• abatacept (Orencia);
• anakinra (Kineret);
• cyclophosphamide (Cytoxan); or
• insulin or oral diabetes medicine.

This list is not complete. Other drugs may interact with etanercept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.