Etanercept

Generic Name: Etanercept (ee-TAN-er-sept)Brand Name: Enbrel Prefilled Syringes

Serious and sometimes fatal infections (eg, bacterial sepsis, tuberculosis [TB]) have occurred in patients using Etanercept . TB may be caused by a new infection or by reactivation of a previous infection. Your doctor will test you for TB and evaluate your risk of developing it. This will occur before and during treatment with Etanercept . If you have TB, you should begin to treat it before you begin treatment with Etanercept .

Contact your doctor right away if you develop chest pain or discomfort; decreased mental alertness; fast heartbeat; fever, chills, or sore throat; general feeling of being unwell; new or worsening cough; rapid breathing; shortness of breath; swelling of the lymph nodes; or unusual diarrhea, nausea, stomach pain, or vomiting.

Etanercept is a tumor necrosis factor (TNF) blocker. Lymphoma and other types of cancer have been reported in children and teenagers treated with TNF blockers. This has been fatal in some cases. Talk with your doctor for more information.

Etanercept is used for:

Treating moderate to severe forms of ankylosing spondylitis (AS), juvenile arthritis, psoriasis, and rheumatoid and psoriatic arthritis. Etanercept may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Etanercept is a type of protein called a TNF blocker. It works by blocking the action of TNF, a substance in the body that causes swelling and painful, swollen joints and raised, thick, red, scaly patches on the skin.

Do NOT use Etanercept if:

  • you are allergic to any ingredient in Etanercept
  • you have an infection that has spread throughout your entire body (sepsis)
  • you have Wegener granulomatosis and are taking a medicine that may weaken the immune system (eg, corticosteroids, methotrexate)
  • you are taking cyclophosphamide or anakinra

Contact your doctor or health care provider right away if any of these apply to you.

Before using Etanercept :

Some medical conditions may interact with Etanercept . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (including latex or rubber)
  • if you 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)
  • if you have a history of infections that keep coming back, have conditions that may increase your risk of infection (eg, diabetes), or live in or have traveled to areas where fungal infections (eg, histoplasmosis) are common
  • if you have a history of TB or a positive TB skin test, or if you have been in close contact with someone who has had TB
  • if you have any numbness or tingling or a disease that affects your nervous system (eg, multiple sclerosis [MS])
  • if you have congestive heart failure, a blood problem (eg, anemia), any lupus-like disease, rectal bleeding, shingles (herpes zoster), or Wegener granulomatosis
  • if you have a history of lymphoma, cancer, or liver problems (eg, hepatitis)
  • if you are scheduled to have major surgery or any kind of vaccination

Some MEDICINES MAY INTERACT with Etanercept . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Costimulation modulators (eg, abatacept) or interleukin-1 receptor antagonist (eg, anakinra) because the risk of serious infections may be increased
  • Cyclophosphamide because the risk of developing cancer may be increased
  • Amphetamines (eg, dextroamphetamine), decongestants (eg, pseudoephedrine), lithium, salicylates (eg, aspirin), or sulfonylureas (eg, glipizide) because additional monitoring of your dose or condition may be necessary

This may not be a complete list of all interactions that may occur. Ask your health care provider if Etanercept may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Etanercept :

Use Etanercept as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Etanercept comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Etanercept refilled.
  • If you will be using Etanercept at home, a health care provider will teach you how to use it. Be sure you understand how to use Etanercept . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Wash your hands with soap and warm water before using Etanercept .
  • Remove one prefilled syringe of Etanercept from the refrigerator. Wait 15 to 30 minutes to allow the medicine in the prefilled syringe to reach room temperature. Do NOT shake the syringe. Do NOT remove the needle cover while allowing it to reach room temperature. Do not warm Etanercept in any other way (do not warm it in a microwave or in hot water).
  • Do not use Etanercept if it contains particles, is cloudy or discolored, or if the syringe is cracked or damaged.
  • Rotate the site for each injection. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, try not to inject directly into any raised, red, thick, or scaly skin patches.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • Do not miss any doses of Etanercept . If you miss a dose of Etanercept , contact your doctor right away to find out when to take your next dose.

Ask your health care provider any questions you may have about how to use Etanercept .

Important safety information:

  • Etanercept may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Etanercept with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Etanercept may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice signs of infection like chest pain or discomfort; chills, fever, or sore throat; decreased mental alertness; fast heartbeat; general feeling of being unwell; new or worsening cough; rapid breathing; shortness of breath; swelling of the lymph nodes; or unusual diarrhea, nausea, stomach pain, or vomiting.
  • Etanercept may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Etanercept may increase the risk of developing blood cancer (eg, leukemia, lymphoma) and other types of cancer. This may be fatal in some cases. Discuss any questions or concerns with your doctor. Tell your doctor if you have ever had cancer. Contact your doctor right away if you develop symptoms of leukemia or lymphoma such as unusual bruising, unusual lumps or swelling (eg, in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness or weakness, persistent unexplained itching, or unexplained weight loss.
  • Some patients who use Etanercept have developed new or worsening psoriasis. Tell your doctor right away if you notice any new or worsening skin problems (eg, red, flaky, or itchy skin patches).
  • If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Contact your doctor if you come into contact with these infections.
  • Before you use Etanercept , discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Etanercept . Talk with your doctor before you receive any vaccine.
  • It may take several weeks for Etanercept to work. Do not stop using Etanercept without checking with your doctor.
  • Tell your doctor or dentist that you take Etanercept before you receive any medical or dental care, emergency care, or surgery.
  • If you develop any of the symptoms of TB (eg, a dry cough that does not go away, fever, night sweats, weight loss), call your doctor. You will need to be examined for TB and have a skin test.
  • Etanercept may interfere with certain lab tests, including tests for TB infection. Be sure your doctor and lab personnel know you are using Etanercept .
  • Use Etanercept with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of developing infections.
  • Caution is advised when using Etanercept in CHILDREN; they may be at increased risk for developing certain types of cancer with Etanercept , which may be fatal.
  • Etanercept should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Etanercept while you are pregnant. It is not known if Etanercept is found in breast milk. Do not breast-feed while using Etanercept .

Possible side effects of Etanercept :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; pain, redness, itching, bruising, or swelling around the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); butterfly rash (rash on nose and cheeks); chest pain or discomfort; decreased mental alertness; fast heartbeat; fever, chills, or sore throat; general feeling of being unwell; increased or painful urination; mental or mood changes; new or worsening cough; numbness or tingling throughout your body; rapid breathing; rash on your face and arms that gets worse in the sun; seizures; shortness of breath; swelling of the arms or legs; swelling of the lymph nodes; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools); unusual bruising or bleeding; unusual lumps; unusual nausea, vomiting, stomach pain, or diarrhea; unusual tiredness or weakness; unusually pale skin; vision problems; weakness in the arms or legs.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Etanercept :

Store Etanercept in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep the prefilled syringes in the original carton to protect them from light until the time of use. Keep Etanercept out of the reach of children and away from pets.

General information:

  • If you have any questions about Etanercept , please talk with your doctor, pharmacist, or other health care provider.
  • Etanercept is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Etanercept . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Etanercept Professional Patient Advice (Wolters Kluwer)
  • Etanercept Detailed Consumer Information (PDR)
  • etanercept Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information
  • Enbrel Prescribing Information (FDA)
  • Enbrel Consumer Overview