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|Enbrel Prefilled Syringes

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Enbrel Prefilled Syringes

Generic Name: Etanercept 50 mg/mL Injection (et-a-NER-sept)
Brand Name: Enbrel Prefilled Syringes

Enbrel Prefilled Syringes is used for:

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

Enbrel Prefilled Syringes 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 Prefilled Syringes if:

you are allergic to any ingredient in Enbrel Prefilled Syringes
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 Prefilled Syringes :

Some medical conditions may interact with Enbrel Prefilled Syringes . 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 allergies to rubber or latex
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 Prefilled Syringes . 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 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 Prefilled Syringes 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 Prefilled Syringes :

Use Enbrel Prefilled Syringes 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 Prefilled Syringes comes with an additional patient leaflet. Read it carefully and reread it each time you get Enbrel Prefilled Syringes refilled.
If you are using Enbrel Prefilled Syringes 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 Prefilled Syringes .
Remove one prefilled syringe of Enbrel Prefilled Syringes 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 Enbrel Prefilled Syringes in any other way (do not warm it in a microwave or in hot water).
If Enbrel Prefilled Syringes contains particles, flakes, is discolored, or if the syringe is cracked or damaged in any way, do not use it.
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 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 Prefilled Syringes . If you miss a dose of Enbrel Prefilled Syringes , 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 Prefilled Syringes .

Important safety information:

Enbrel Prefilled Syringes may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Enbrel Prefilled Syringes . Using Enbrel Prefilled Syringes alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Enbrel Prefilled Syringes 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 Prefilled Syringes 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 Prefilled Syringes , 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 Prefilled Syringes .
It may take several weeks for Enbrel Prefilled Syringes to work. Do not stop using this medicine 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 Prefilled Syringes .
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.
The needle cover of the prefilled syringe contains natural rubber (latex) which may cause allergic reactions in individuals sensitive to this substance. 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 Prefilled Syringes with caution in the ELDERLY because they may be more at risk to develop infections.
Enbrel Prefilled Syringes 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 Prefilled Syringes during pregnancy. It is unknown if Enbrel Prefilled Syringes is excreted in breast milk. Do not breast-feed while taking Enbrel Prefilled Syringes .

Possible side effects of Enbrel Prefilled Syringes :

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); fever; mental/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 Prefilled Syringes :

Store Enbrel Prefilled Syringes 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 Enbrel Prefilled Syringes out of the reach of children and away from pets.

General information:

If you have any questions about Enbrel Prefilled Syringes , please talk with your doctor, pharmacist, or other health care provider.
Enbrel Prefilled Syringes 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 Prefilled Syringes . 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

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