Etanercept Solution for injection

What is this medicine?

ETANERCEPT (et a NER sept) is used for the treatment of rheumatoid arthritis in adults and children. The medicine is also used to treat psoriatic arthritis, ankylosing spondylitis, and psoriasis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood disorders

• cancer

• congestive heart failure

• diabetes

• exposure to chickenpox

• immune system problems

• infection

• multiple sclerosis

• seizure disorder

• tuberculosis, a positive skin test for tuberculosis or have recently been in close contact with someone who has tuberculosis

• Wegener's granulomatosis

• an unusual or allergic reaction to etanercept, latex, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

The medicine is given by injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, contact your health care professional to find out when you should take your next dose. Do not take double or extra doses without advice.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• anakinra

This medicine may also interact with the following medications:

• cyclophosphamide

• sulfasalazine

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You will be tested for tuberculosis (TB) before you start this medicine. If your doctor prescribes any medicine for TB, you should start taking the TB medicine before starting this medicine. Make sure to finish the full course of TB medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• fever, chills or any other sign of infection

• numbness or tingling in legs or other parts of the body

• red, scaly patches or raised bumps on the skin

• shortness of breath or difficulty breathing

• swollen lymph nodes in the neck, underarm, or groin areas

• unexplained weight loss

• unusual bleeding or bruising

• unusual swelling or fluid retention in the legs

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• headache

• nausea

• redness, itching, or swelling at the injection site

• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or shake. Protect from light. Throw away any unused medicine after the expiration date.

You will be instructed on how to store this medicine.