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|ENBREL

ETANERCEPT (Systemic)

Some commonly used brand names are:

In the U.S.—

• ENBREL

Category

• Antirheumatic (biologic response modifier)

Description

Etanercept (ee-tan-NER-cept) is injected under the skin to reduce signs and symptoms of active arthritis or rheumatoid arthritis, such as joint swelling, pain, tiredness, and duration of morning stiffness. This medicine may also slow the progression of damage to the body from active arthritis or rheumatoid arthritis. It may also be used to treat psoriasis or a condition known as ankylosing spondylitis.

This medicine is available only with your doctor"s prescription, in the following dosage form(s):

• Parenteral
• Injection, vial or prefilled syringe (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For etanercept, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to etanercept or any of its components. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

The needle cover on the prefilled diluent syringe is lined with latex (rubber product). If you are allergic to latex (rubber products), talk to your doctor before using.

Pregnancy—Etanercept has not been studied in pregnant women. Etanercept has not been shown to cause birth defects or other problems in animal studies. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether etanercept passes into breast milk. However, etanercept may possibly cause serious side effects in nursing infants. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Etanercept has been tested in children 4 to 17 years of age. Studies indicate that etanercept may reduce signs and symptoms in patients with juvenile rheumatoid arthritis. Stomach pain, nausea, headache, and vomiting were seen more often in children than in adults.

Older adults—Etanercept has been tested in elderly patients and has not been found to cause different side effects or problems in older people than it does in younger adults. Caution should be used in elderly patients who are taking etanercept because they may be more likely to get an infection.

Other medicines— Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking etanercept, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Anakinra (e.g., Kineret)—May cause serious infection or neutropenia (decrease in white blood cells) when used together with etanercept
• Cyclophosphamide (e.g., Cytoxan)—May cause malignancies, these are not recommended while you are taking etanercept
• Immunosuppressive agents—These should not be taken while you are taking etanercept if you have Wegener"s granulomatosis
• Vaccines, live virus—These should not be taken while you are taking etanercept

Other medical problems—The presence of other medical problems may affect the use of etanercept. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to etanercept or any of its ingredients
• Serious infection that spreads through the bloodstream—You should not use etanercept if you have either of these conditions

• Blood disorders—Etanercept may make these diseases worse or cause them to appear in susceptible patients

• Cancer (or history of) or
• Diabetes mellitus (sugar diabetes) or
• Disease of the immune system (or history of) or
• Infections, serious infections, or continual infections—Etanercept may decrease the body"s ability to fight infection

• Diseases of the central nervous system, such as multiple sclerosis—Etanercept may make these diseases worse in susceptible patients

• Heart failure—May make heart conditions worse; use with caution

• Lung problems—May make lung problems worse; use with caution

• Seizure disorder—May make this condition worse; use with caution

• Wegener"s granulomatosis—May be at greater risk of side effects

Proper Use of This Medicine

If you are injecting this medicine yourself, each package of etanercept will contain a patient instruction sheet. Read this sheet carefully and make sure you understand :

• How to prepare the injection
• How to give the injection
• Proper use and disposal of syringes
• How long the injection is stable
• How to store the medication

Dosing—The dose of etanercept may be different for different patients. Your doctor will decide on the right dose for you.

• For prefilled syringe injection dosage form:
  • For the reduction of signs and symptoms of juvenile rheumatoid arthritis
    • Children 4 to 17 years of age and 138 pounds of body weight or more—0.8 milligram (mg) per kg (0.36 mg per pound) of body weight up to 50 mg, injected under the skin once a week.
    • Children under 4 years of age—Use and dose must be determined by your doctor.
  • For the reduction of signs and symptoms of rheumatoid arthritis or psoriatic arthritis, or to treat ankylosing spondylitis:
    • Adults—50 mg injected under the skin once a week.
    • Children—Use and dose must be determined by your doctor.
  • For plaque psoriasis:
    • Adults—50 mg injected under the skin twice a week for 3 months, then 50 mg injected under the skin once a week.
    • Children up to 18 years—Use and dose must be determined by your doctor.
• For vial injection dosage form:
  • For the reduction of signs and symptoms of juvenile rheumatoid arthritis:
    • Children 4 to 17 years of age and 68 to 136 pounds of body weight—0.4 milligram (mg) per kg (0.18 mg per pound) of body weight injected under the skin twice a week, or 0.8 mg per kg (0.36 mg per pound) of body weight once a week given as 2 injections under the skin at different sites.
    • Children 4 to 17 years of age and less than 68 pounds of body weight— 0.8 mg per kg (0.36 mg per pound) of body weight once a week.
    • Children under 4 years of age—Use and dose must be determined by your doctor.
  • For the reduction of signs and symptoms of rheumatoid arthritis or psoriatic arthritis, or to treat ankylosing spondylitis :
    • Adults—25 mg injected under the skin twice a week.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Your body"s ability to fight infection may be reduced while you are being treated with etanercept, it is very important that you call your doctor at the first signs of any infection (for example, if you get a fever or chills).

While you are being treated with etanercept, do not have any immunizations (vaccinations) without your doctor"s approval . Live virus vaccinations should not be given for 3 months before or while receiving etanercept.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Frequency not determined (side effects in adults)

Incidence not determined (side effects in children)

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above also may occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, etanercept is used in certain patients with the following medical condition:

• Reactive arthritis
• Inflammatory bowel disease arthritis

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Developed: 06/03/1999
Revised: 11/01/2005

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