etanercept

Do not use or handle this medication without first talking to your doctor if you have an allergy to latex. The needle cover is made from latex and you may have an allergic reaction to it.

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.

Etanercept is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use etanercept without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether etanercept passes into breast milk. Do not use etanercept without first talking to your doctor if you are breast-feeding a baby.

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.

Storage of etanercept products:

• 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.

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

In rare cases, etanercept has caused serious blood problems. Notify your doctor immediately if you develop persistent fever; extreme or unusual fatigue; unexplained or prolonged bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as sore throat or pale skin. These symptoms may be signs of blood problems.

If you experience and of the following serious side effects, stop using etanercept, and seek emergency medical attention or contact your doctor immediately:

• 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.

Do not use or handle this medication without first talking to your doctor if you have an allergy to latex. The needle cover is made from latex and you may have an allergic reaction to it.

In rare cases, etanercept has caused serious blood problems. Notify your doctor immediately if you develop persistent fever; extreme or unusual fatigue; unexplained or prolonged bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as sore throat or pale skin. These symptoms may be signs of blood problems.

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.

Do not receive any vaccination that involves the use of a live vaccine while using etanercept, without first talking to your doctor. Etanercept may affect the immune system and a live vaccine could possibly result in an infection.

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.

Seek emergency medical attention or notify your doctor if an overdose of etanercept is suspected.

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