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Generic Name: etanercept (injectable) (eh TAH ner cept)
Brand Names: Enbrel

What is etanercept?

Etanercept reduces the actions of chemicals in the body that are involved in inflammatory and immune responses.

Etanercept is used to treat the symptoms of moderate to severe rheumatoid arthritis, polyarticular-course juvenile rheumatoid arthritis (JRA), psoriatic arthritis, ankylosing spondylitis, and psoriasis.

Etanercept may also be used for purposes other than those listed in this medication guide.

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

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

Before using etanercept, tell your doctor if you

• have an allergy to benzyl alcohol;

• have suppression of the immune system;

• have a bone marrow disease;

• have a demyelinating disorder such as multiple sclerosis, myelitis, or optic neuritis;

• have seizures;

• have congestive heart failure;

• need to have surgery;

• 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);

• have a history of infections that keep coming back or other conditions, like diabetes, that might increase your risk of infections;

• have a history of tuberculosis or have close contact with someone with tuberculosis;

• have recently received a live vaccine; or

• have poorly controlled diabetes.

You may not be able to use etanercept, or you may require a dosage adjustment or special monitoring during your treatment.

If you develop any of the symptoms of tuberculosis (a dry cough that doesn't go away, weight loss, fever, night sweats) call your doctor. You will need to be examined for TB and have a skin test.

How should I use etanercept?

Use etanercept exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Your healthcare provider will give you detailed instructions on how and where to inject etanercept. Do not inject this medication if you are unsure how.

Etanercept is used as a subcutaneous (under the skin) injection only. Injections can be given in the front of the middle of the thigh, abdomen (except around the navel), or the back outer area of the upper arm. It is important to rotate the site of injection with each dose to reduce the risk of injection site reactions or damage to the tissue. Do not inject this medication into any site that is red, painful, or hard.

Do not inject etanercept if it is discolored, cloudy, or if it has particles in it.

Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.

It is important to use etanercept regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations during treatment with etanercept to monitor progress and side effects.

• Single-use prefilled syringes: Do not use a prefilled syringe beyond the expiration date stamped on the carton or syringe barrel label. The prefilled syringes must be refrigerated at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit). Do not freeze. Keep the etanercept prefilled syringes in the original carton to protect from light until the time of use. Do not shake.

• Multiple-use vials: Do not use a dose tray beyond the expiration date stamped on the carton, dose tray label, vial label, or diluent syringe label. The dose tray containing etanercept (sterile powder) must be refrigerated at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit). Do not freeze.

• Reconstituted (mixed) solutions of etanercept prepared with the supplied Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol), using a 25-gauge needle, may be stored for up to 14 days if refrigerated at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit). Discard reconstituted solution after 14 days. The product stability and sterility cannot be assured after 14 days.

What happens if I miss a dose?

If you miss a dose of etanercept contact your doctor to find out when to take your next dose.

What happens if I overdose?

Symptoms of an etanercept overdose are not known. No harmful effects due to large doses of etanercept have been reported.

What should I avoid while using etanercept?

Etanercept can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.

Etanercept side effects

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• new or worsening neurologic symptoms such as worsening muscle pain, weakness or numbness; visual disturbances; seizures; or

• depression or other psychological changes.

If you develop any of the symptoms of tuberculosis (a dry cough that doesn't go away, weight loss, fever, night sweats) call your doctor. You will need to be examined for TB and have a skin test.

You may have reactions where the injection is given. These reactions are usually mild and can include redness, rash, swelling, itching, or bruising. These reactions usually go away within 3 to 5 days. If you have pain, redness or swelling around the injection site that doesn't go away or gets worse, call your doctor immediately.

Other less serious side effects may be more likely to occur. Continue to use etanercept and notify your doctor if you experience

• a headache; or

• sinus infection.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect etanercept?

Before using etanercept, talk to your doctor if you are using anakinra (Kineret). You may not be able to use etanercept, or you may require a dosage adjustment or special monitoring during treatment.

It is not known if other drugs interact with etanercept. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist has more information about etanercept written for health professionals that you may read.

What does my medication look like?

Etanercept is available with a prescription under the brand name Enbrel. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Corner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.