In the U.S.—

• Antirheumatic (biologic response modifier)

Etanercept (ee-tan-NER-cept) is injected under the skin to reduce signs and symptoms of 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 rheumatoid arthritis. It may also be used to treat a condition known as ankylosing spondylitis.

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

Parenteral
• Injection (U.S.)

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 pre-filled 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.

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 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.

Other medicines—Tell your health care professional if you are using any other prescription, nonprescription (over-the-counter [OTC]) medicine, or vaccinations.

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

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

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

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 injection dosage form:
  • For the reduction of signs and symptoms of rheumatoid arthritis, juvenile rheumatoid arthritis, or to treat ankylosing spondylitis :
    • Adults—25 mg injected under the skin twice a week.
    • Children 4 to 17 years of age—0.4 milligrams (mg) per kg (0.88 mg per pound) of body weight, injected under the skin twice a week.
    • Children under 4 years of age—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.

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.

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.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Chills;  cough;  fever;  skin rash on face, scalp, or stomach;  sneezing 
  
  

• Less common
  • Congestion in chest;  dizziness;  fainting;  fast heartbeat;  frequent or painful urination;  headache ;  itching, pain, redness, or swelling on the skin ;  joint or muscle pain;  joint or muscle stiffness, tightness, or rigidity;  light-headedness;  nausea and/or vomiting;  stomach discomfort and/or pain;  wheezing  
  
  

• Rare
  • Blindness;  blue-yellow color blindness ;  blurred vision;  decreased vision;  convulsions;  eye pain;  black, tarry stools;  headache;  nosebleeds;  numbness or tingling in legs or feet;  pale skin;  problems with bowel or bladder function;  shortness of breath;  sores, ulcers, or white spots on lips or in mouth;  swollen or painful glands;  tightness in chest;  unusual tiredness or weakness;  unusual bleeding or bruising;  wheezing 
  
  

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:

• More common
  • Abdominal pain—more common in children;  nausea and vomiting—more common in children;  pain or burning in throat;  redness and/or itching, pain, or swelling at the site of injection (under the skin);  runny or stuffy nose 
  
  

• Less common
  • Depression;  diarrhea;  heartburn;  loss of energy or weakness 
  
  

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

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.