Enbrel Multiple-Use Vials

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Enbrel Multiple-Use Vials


Generic Name: Etanercept 25 mg/mL Injection (et-a-NER-sept)
Brand Name: Enbrel Multiple-Use Vials

Enbrel Multiple-Use Vials is used for:

Treating moderate to severe forms of rheumatoid arthritis and psoriatic arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, and psoriasis. Enbrel Multiple-Use Vials may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Enbrel Multiple-Use Vials is a type of protein called a tumor necrosis factor (TNF) inhibitor. 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 Enbrel Multiple-Use Vials if:

  • you are allergic to any ingredient in Enbrel Multiple-Use Vials
  • you have an infection that has spread throughout your entire body (sepsis)
  • you have Wegener"s granulomatosis and are taking a medicine that may weaken the immune system (eg, methotrexate, corticosteroids)
  • you are taking cyclophosphamide

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

Before using Enbrel Multiple-Use Vials :

Some medical conditions may interact with Enbrel Multiple-Use Vials . 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
  • 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 or other conditions (eg, diabetes) that may increase your risk of infections
  • if you have tuberculosis (TB) 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 disease, any lupus-like disease, rectal bleeding, shingles (herpes zoster), or Wegener"s granulomatosis
  • if you are scheduled to have major surgery or any kind of vaccination

Some MEDICINES MAY INTERACT with Enbrel Multiple-Use Vials . 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 antagonists (eg, anakinra) because the risk of getting a serious infection may be increased
  • Cyclophosphamide because the risk of developing cancer may be increased
  • Amphetamines (eg, dextroamphetamine), lithium, salicylates (eg, aspirin), sulfonylureas (eg, glipizide), or a decongestant (eg, pseudoephedrine) 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 Enbrel Multiple-Use Vials 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 Enbrel Multiple-Use Vials :

Use Enbrel Multiple-Use Vials as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

  • Enbrel Multiple-Use Vials comes with an additional patient leaflet. Read it carefully and reread it each time you get Enbrel Multiple-Use Vials refilled.
  • If you are using Enbrel Multiple-Use Vials at home, carefully follow the injection procedures taught to you by your doctor. The first injection will be given under the supervision of your doctor.
  • Wash your hands with soap and warm water before using Enbrel Multiple-Use Vials .
  • The dose tray containing the vials of powder must be refrigerated. Do not freeze.
  • Use an alcohol swab to clean the gray stopper on the vial. Do not touch the stopper with your hands.
  • Do not shake Enbrel Multiple-Use Vials . Inspect the injection solution for particles or discolored matter before using. The solution should be clear and colorless. If Enbrel Multiple-Use Vials contains particles, flakes, or is discolored, or if the syringe is cracked or damaged in any way, do not use it.
  • If all the powder in the vial is not dissolved or there are particles present after 10 minutes, do not inject and contact your health care provider.
  • The syringe, needles, and vial adapter should never be reused. Never recap a needle.
  • 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.
  • You may see improvement of your symptoms as soon as 1 to 2 weeks after starting Enbrel Multiple-Use Vials . Up to 3 months of treatment may be needed for some patients.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • Do not miss any doses of Enbrel Multiple-Use Vials . If you miss a dose of Enbrel Multiple-Use Vials , contact your doctor to find out when to take your next dose.

Ask your health care provider any questions you may have about how to use Enbrel Multiple-Use Vials .

Important safety information:

  • Enbrel Multiple-Use Vials may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Enbrel Multiple-Use Vials . Using Enbrel Multiple-Use Vials alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Enbrel Multiple-Use Vials may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
  • Enbrel Multiple-Use Vials may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
  • If you have not had chickenpox or measles, avoid contact with anyone who has either of these diseases. If you come in contact with someone who has chickenpox or measles, contact your doctor.
  • Before you use Enbrel Multiple-Use Vials , discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations.
  • Avoid receiving live vaccines while using Enbrel Multiple-Use Vials .
  • It may take several weeks for Enbrel Multiple-Use Vials to work. Do not stop using Enbrel Multiple-Use Vials without checking with your doctor.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Enbrel Multiple-Use Vials .
  • If you develop any of the symptoms of TB (a dry cough that does not go away, weight loss, fever, night sweats), call your doctor. You will need to be examined for TB and have a skin test.
  • Tell your doctor if you are allergic to rubber or latex.
  • LAB TESTS may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Enbrel Multiple-Use Vials with caution in the ELDERLY because they may be more at risk to develop infections.
  • Enbrel Multiple-Use Vials is not recommended for use in CHILDREN younger than 4 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Enbrel Multiple-Use Vials during pregnancy. It is unknown if Enbrel Multiple-Use Vials is excreted in breast milk. Do not breast-feed while taking Enbrel Multiple-Use Vials .

Possible side effects of Enbrel Multiple-Use Vials :

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; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); butterfly rash (rash on nose and cheeks); dizziness; fever; mental or mood changes; numbness or tingling throughout your body; rash on your face and arms that gets worse in the sun; seizures; serious infection (bleeding, bruising, pale skin, persistent fever); swelling of arms or legs; unusual lumps; unusual tiredness; upper respiratory tract infection; vision problems; weakness in arms or legs.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Proper storage of Enbrel Multiple-Use Vials :

Store the unmixed medicine in its dose tray in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze.

The mixed medicine may be stored in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C) for up to 14 days. Do not freeze. Discard mixed solution after 14 days. Keep Enbrel Multiple-Use Vials out of the reach of children and away from pets.

General information:

  • If you have any questions about Enbrel Multiple-Use Vials , please talk with your doctor, pharmacist, or other health care provider.
  • Enbrel Multiple-Use Vials 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 Enbrel Multiple-Use Vials . 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.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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