Etanercept Injection (patient information)

Why this medication is prescribed

Etanercept is used alone or in combination with other medications to reduce the pain and swelling associated with rheumatoid arthritis, juvenile rheumatoid arthritis, and psoriatic arthritis. Etanercept is in a class of medications called tumor-necrosis factor (TNF) inhibitors. It works by blocking the activity of TNF, a substance in the body that causes swelling and joint damage in arthritis.

How this medication should be used

Etanercept comes as a solution to inject subcutaneously (under the skin). It is usually injected twice a week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use etanercept exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You can inject etanercept in the thigh, stomach, or upper arm. To reduce the chances of soreness or redness, use a different site for each injection.The new injection should be given at least 1 inch away from the previous injection. Do not inject into an area where the skin is tender, bruised, red, or hard.

Dispose of used needles and syringes in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Before you use etanercept for the first time, read the manufacturer's information for the patient that comes with it. Ask your doctor or pharmacist to show you how to inject etanercept.

Before preparing an etanercept dose, wash your hands with soap and water. To prepare the area of the skin where you will inject etanercept, wipe it with an alcohol swab.

To prepare and inject etanercept, follow these steps:

1. Remove the pink plastic cap from the etanercept vial. Do not remove the gray stopper or silver metal ring.
2. Clean the gray stopper on the vial with an alcohol swab. Place the vial on a flat surface. Do not touch the stopper.
3. Slide the plunger into the syringe and turn it clockwise until it becomes more difficult to turn.
4. Pull the needle cover straight off the syringe. Do not touch the needle or allow it to touch anything, and do not push the plunger.
5. Insert the needle straight down through the center ring of the gray stopper of the etanercept vial. You will hear a pop as the needle goes through the stopper. You should see the needle tip in the stopper window.
6. Push the plunger down very slowly until all the liquid from the syringe is in the vial. Leave the syringe in place, and gently swirl the vial between your fingers in a circular motion to dissolve the powder. Do not shake.
7. The powder should dissolve in less than 10 minutes. The solution should be clear and colorless. There may be some bubbles in the solution. Do not inject the solution if it contains lumps, flakes, or particles.
8. To withdraw the solution from the vial, turn the vial upside down and hold it at eye level. Slowly pull the plunger down to the marking on the side of the syringe that corresponds to the correct dose. Make sure to keep the tip of the needle in the solution.
9. With the needle still inserted in the vial, check for air bubbles in the syringe. Gently tap the syringe to make any air bubbles rise to the top of the syringe. Then slowly push the plunger up to remove the air bubbles. If any solution is pushed back into the vial, slowly pull back on the plunger to draw the solution back into the syringe.
10. Remove the syringe and needle from the vial. Be careful not to touch the needle or touch it to any surface.
11. Gently pinch the cleaned area of skin with one hand and hold it firmly. With the other hand, hold the syringe like a pencil at a 45 degree angle to the skin.
12. Push the needle into the skin, and let go of the skin with the other hand.
13. Use the other hand to slowly push the plunger down to inject etanercept.
14. When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as when it was inserted.

If it is hard for you to prepare a dose because of arthritis of the hand, you may use another method to prepare etanercept. Speak to your health care provider and refer to the manufacturer's information.

Some children may use one vial of etanercept solution for more than one dose. Do not mix the contents of one etanercept vial with the contents of another vial. Ask your health care provider for directions on how to prepare a dose from a vial that was already used.

Other uses for this medicine

Etanercept is also used sometimes to treat psoriasis and ankylosing spondylitis. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before taking etanercept:

• tell your doctor and pharmacist if you are allergic to etanercept, latex, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have an infection anywhere in the body and if you have or have ever had seizures, multiple sclerosis, inflammation of the optic nerve (optic neuritis), blood abnormalities, human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), diabetes, or heart failure.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking etanercept, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking etanercept.
• do not have any vaccinations (e.g., measles or flu shots) without talking to your doctor.
• if you are exposed to chickenpox while taking etanercept, call your doctor immediately.

Special dietary instructions

Unless your doctor tells you otherwise, continue your normal diet.

What to do if you forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects

Minor Side Effects

Etanercept may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, itching, pain, or swelling at the site of injection
• bleeding or bruising at the site of injection
• runny nose
• sneezing
• headache
• dizziness
• upset stomach
• vomiting
• stomach pain
• weakness
• cough

Severe Side Effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• fever, sore throat, chills, and other signs of infection
• coughing, wheezing, or chest pain
• hot, red, swollen area on the skin
• seizures
• bruising
• bleeding
• pale skin
• hives
• itching
• difficulty breathing or swallowing
• severe rash

Etanercept may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tray containing etanercept powder in the refrigerator. Do not freeze. Once water is added to the powder, the solution may be stored in the refrigerator for up to 14 days. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Other information

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to etanercept.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Enbrel®