etanercept

What is the most important information I should know about etanercept?

What is etanercept?

Etanercept is a tumor necrosis factor (TNF) blocker that is used in adults to prevent joint damage caused by rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

Etanercept is also used to treat plaque psoriasis in adults and children at least 4 years old.

Etanercept is used to treat polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.

Etanercept is sometimes used with another medicine called methotrexate.

Etanercept may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using etanercept?

Tell your doctor if you have any signs of infection, such as:

• fever, chills, sweats, flu-like symptoms, feeling very tired;
• cough, shortness of breath, coughing up blood;
• diarrhea, weight loss;
• skin warmth or redness, open sores; or
• increased urination, burning when you urinate.

Tell your doctor if you have ever had:

• a weak immune system, HIV, tuberculosis;
• hepatitis B;
• diabetes;
• congestive heart failure;
• a nerve disorder such as multiple sclerosis or Guillain-Barré syndrome;
• seizures;
• a latex allergy; or
• if you are scheduled to receive any vaccines.

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

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you are pregnant or plan to become pregnant. You will need to tell your baby's doctor if you used etanercept during pregnancy, especially before the baby receives any childhood vaccines.

How should I use etanercept?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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. A healthcare provider may teach you how to properly use the medication by yourself. 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 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 properly mix and store the medicine.

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 etanercept.

Etanercept affects your immune system. 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.

Carefully follow all storage instructions provided with your medicine. Cartridges, injection pens, prefilled syringes, vials, and diluent are stable at specific temperatures for only a certain number of days or weeks. Throw away any medicine not used within that time.

Protect the medicine from light and extreme hot or cold temperatures. Once the medicine has reached room temperature, do not put it back into the refrigerator.

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.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using etanercept?

Avoid injecting etanercept into skin that is bruised, tender, red, or hard.

Do not receive a "live" vaccine while using etanercept. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using etanercept.

What are the possible side effects of etanercept?

• 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); o
• liver problems --right-sided upper stomach pain, vomiting, tiredness, loss of appetite, yellowing of your skin or eyes.

Common side effects may include:

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

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 FDA at 1-800-FDA-1088.

What other drugs will affect etanercept?

Tell your doctor about all your other medicines, especially:

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

This list is not complete. Other drugs may affect etanercept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about etanercept.