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(et a ner' set)Using etanercept injection may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe viral, bacterial, or fungal infections that spread throughout the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores) and chronic infections that do not go away. Also tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV) , acquired immunodeficiency syndrome (AIDS), or any other condition that affects your immune system. You should also tell your doctor if you live or have ever lived in areas such as the Ohio and Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you do not know if these infections are common in your area. Also tell your doctor if you are taking medications that decrease the activity of the immune system such as the following: abatacept (Orencia); anakinra (Kineret); azathioprine (Imuran); steroids including dexamethasone, methylprednisolone (Medrol), prednisolone (Prelone) and prednisone; or methotrexate (Rheumatrex). Your doctor will monitor you for signs of infection during and shortly after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: weakness; sweating; difficulty breathing; sore throat; cough; coughing up bloody mucus; fever; weight loss; extreme tiredness; diarrhea; stomach pain; flu-like symptoms; warm, red, or painful skin; or other signs of infection. You may be infected with tuberculosis (TB, a type of lung infection) or hepatitis B (a type of liver disease) but do not have any symptoms of the disease. In this case, etanercept injection may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order blood tests to see if you have an inactive hepatitis B infection. If necessary, your doctor will give you medicine to treat this infection before you begin using etanercept injection. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone, or fever. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash. Some children and teenagers who received etanercept injection and similar medications developed severe or life-threatening cancers including lymphoma (cancer that begins in the cells that fight infection). If your child develops any of these symptoms during his treatment, call his doctor immediately: unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding. Talk to your child's doctor about the risks of giving etanercept injection to your child. Talk to your doctor about the risks of using etanercept injection.
- rheumatoid arthritis (condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in adults,
- psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) in adults,
- juvenile idiopathic arthritis (JIA; a condition that affects children in which the body attacks its own joints, causing pain, swelling, loss of function, and delays in growth and development) in children 2 years of age and older,
- ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage),
- chronic plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults and children 4 years of age and older whose psoriasis is too severe to be treated by topical medications alone.
Before using etanercept injection,
- tell your doctor and pharmacist if you are allergic to etanercept or any other medications. If you will be using the prefilled syringe or automatic injection device, tell your doctor if you or the person who will be injecting the medication for you are allergic to rubber or latex.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section, medications for diabetes, and cyclophosphamide (Cytoxan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had seizures; a disease that affects your nervous system, such as multiple sclerosis (MS; loss of coordination, weakness, and numbness due to nerve damage); transverse myelitis (inflammation of the spinal cord that may cause abnormal sensations, loss of sensation, or loss of ability to move the lower body); optic neuritis (inflammation of the nerve that sends messages from the eye to the brain); bleeding problems ; liver disease, or heart failure.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using etanercept, call your doctor. If you use etanercept injection during your pregnancy, be sure to talk to your baby's doctor about this after your baby is born. Your baby may need to receive certain vaccinations later than usual.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using etanercept.
- do not have any vaccinations during your treatment with etanercept without talking to your doctor. If your child will be treated with etanercept injection, talk to his or her doctor about vaccinations that should be given before the start of treatment. If possible, your child should be given all vaccinations needed for children of his or her age before beginning treatment.
- if you are exposed to chickenpox while using etanercept, call your doctor immediately.
- redness, itching, pain, or swelling at the site of injection
- stomach pain
- pale skin
- blistering skin
- swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- rash on the face and arms that worsens in the sun
- numbness or tingling
- vision problems
- weakness in the arms or legs
- red, scaly patches or pus-filled bumps on the skin