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February 10, 2012
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etanercept - injection, Enbrel (cont.)

HOW TO USE: Read the Medication Guide and the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Etanercept is injected under the skin of the thigh, abdomen, or upper arm, usually once or twice weekly exactly as prescribed by your doctor.Your dosage is based on your medical condition and response to treatment. Do not change your dose without first consulting your doctor. Use this medication regularly in order to get the most benefit from it. You should start to see an improvement in 1 to 2 weeks. It may take up to 3 months to receive the full benefit of this medication.If you will be giving yourself the injection, your doctor may want you to have the first injection in the medical office. Make sure you learn the proper way to inject this medication from your health care professional, as described in the Patient Information Leaflet from the manufacturer.Remove the medication from the refrigerator and allow it to warm to room temperature before injecting. This takes about 15 to 30 minutes. Do not shake the product. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site each time you use this drug to prevent problems under the skin. New injections should be given at least 1 inch (2.5 centimeters) from an old injection site. Do not inject into areas of the skin that are sore, bruised, red, or hard.Learn how to store and discard needles and medical supplies safely. Consult your pharmacist. Never reuse needles or syringes.Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: See also Warning section.Redness, itching, pain, or swelling at the injection site may occur. This usually starts 1-2 days after the injection and clears up in 3-5 days. Injection site reactions usually lessen after the first month. Headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you develop signs of infection while using this drug, such as: fever, chills, persistent sore throat, persistent cough, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).Tell your doctor right away if you have any serious side effects, including: a rash on nose and cheeks (butterfly rash), dizziness, extreme fatigue, looking pale, hair loss, swelling of the arms/legs, unusual bruising/bleeding, severe headache, mental/mood changes, seizures, unexplained muscle weakness, numbness/tingling of the hands/feet, unsteadiness, vision changes, severe stomach/abdominal pain, persistent nausea/vomiting, dark urine, yellowing eyes/skin.An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.



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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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