(ee TAN er sept) Brand: Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick
• Some people using etanercept have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using etanercept or similar medicines to treat Crohn's malady or ulcerative colitis.
• Call your doctor at once if you have any of the next symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a little amount, pain in your upper stomach that may spread to your shoulder, nausea, light bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart course, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
• Etanercept can lower blood cells that help your body fight infections. Your blood may need to be tested often. Serious and sometimes fatal infections may occur during treatment with etanercept. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, weary feeling, or if you feel short of breath.
• Children using this medicine must be current on all childhood immunizations till starting treatment with etanercept.
• Etanercept works by decreasing a determined protein produced by the immune system. The immune system helps the body fight infections. In people with autoimmune disorders, the immune system mistakes the body's own cells for invaders and attacks them.
• Etanercept is used to treat the symptoms of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, and to prevent joint hurt caused by these conditions. It is also used to treat plaque psoriasis in adults and polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.
• Etanercept may also be used for purposes not listed in this medicine guide.
• You must not use this medicine if you are allergic to etanercept, or if you have a severe infection such as sepsis (infection of the blood).
• Some people using etanercept have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using etanercept or similar medicines to treat Crohn's malady or ulcerative colitis. However, people with autoimmune disorders (including psoriasis) may have a higher risk of lymphoma. Conversation to your doctor about your individual risk.
• Till using etanercept, speak your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
• To create certain you can safely use etanercept, speak your doctor if you have any of these another conditions:
· a weak immune system, or any type of infection including a skin infection or open sores;
· diabetes;
· congestive heart failure;
· a nerve mess such as multiple sclerosis, myelitis, or optic neuritis;
· epilepsy or another seizure disorder;
· asthma or another breathing disorder;
· if you have ever had hepatitis B;
· if you are allergic to latex rubber; or
· if you are scheduled to receive any vaccines, or if you have recently been vaccinated with BCG (Bacille Calmette-Guerin).
• FDA pregnancy category B. Etanercept is not expected to be deleterious to an unborn child. Speak your doctor if you are pregnant or plan to become pregnant during treatment.
• It is not known whether etanercept passes into breast milk or if it could harm a nursing child. Do not use this medicine without telling your doctor if you are breast-feeding a baby.
• Children using this medicine must be current on all childhood immunizations till starting treatment with etanercept.
• Till you start treatment with etanercept, your doctor may perform trials to create certain you do not have tuberculosis or another infections. Some infections are more likely to occur in determined areas of the world. Speak your doctor where you live and where you have recently traveled or plan to travel to during treatment.
• Etanercept is injected under the skin. You may be shown how to use injections at house. Do not self inject this medication if you do not fully understand how to give the injection and properly dispose of used needles and syringes. You may need to mix etanercept with a liquid (diluent) till using it. If you are using the injections at house, be certain you understand how to properly mix and store the medication.
• A baby should weigh at least 138 pounds to use the Sureclick autoinjector. Children who weigh smaller than 138 pounds must use a various form of etanercept.
• Use a various seat on your body every time you give the injection. Your care provider will show you the excellent places on your body to inject the medicine. Do not inject into the same seat two times in a row. Avoid injecting into skin that is bruised, tender, red, or hard.
• You may have pain, redness, swelling, or warmth where the medication was injected. Call your doctor if these symptoms continue for longer than 5 days.
• Use every disposable needle only one time. A single-use prefilled syringe or Sureclick autoinjector is for one injection only. Throw the used syringe or autoinjector away after one use, even if there is still medication left in it. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Hold this container out of the reach of children and pets.
• Etanercept can lower blood cells that help your body fight infections. Your blood may need to be tested often. Serious and sometimes fatal infections may occur during treatment with etanercept. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, weary feeling, or if you feel short of breath.
• If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for different months after you stop using etanercept. Visit your doctor regularly.
• If you need surgery, speak the surgeon onward of time that you are using etanercept.
• Store this medicine in the refrigerator. Do not freeze. After mixing etanercept with a diluent, store in the refrigerator and use it within 14 days. Do not use etanercept after the expiration date on the label has passed.
• Do not shake the prefilled syringe. Vigorous shaking can ruin the medication. Do not use the medicine if it has changed colors or appears cloudy. Call your doctor for a new prescription.
• Call your doctor for instructions if you miss your etanercept dose.
• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.
• Do not receive a "live" vaccine while using etanercept, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.
• Avoid being around people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox.
• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.
• Stop using etanercept and call your doctor right away if you have any of these symptoms of lymphoma:
· fever, night sweats, weight loss, tiredness;
· feeling full after eating only a little amount;
· pain in your upper stomach that may spread to your shoulder;
· light bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart course; or
· nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
• Stop using etanercept and call your doctor at once if you have any of these another serious side effects:
· signs of infection (fever, chills, sore throat, body aches, confusion, neck stiffness, flu symptoms);
· shortness of breath with swelling, rapid weight gain;
· chest pain, ongoing cough, coughing up mucus or blood;
· signs of skin infection such as itching, swelling, warmth, redness, or oozing;
· black, bloody, or tarry stools;
· changes in mood or personality (in children);
· numbness, burning, pain, or tingly feeling;
· joint pain or swelling with fever, swollen glands, muscle aches, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
· patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).
• Smaller serious side effects may include:
· mild nausea, vomiting, mild diarrhea, mild stomach pain;
· runny or stuffy nose, cool symptoms; or
· headache.
• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.
• Speak your doctor about all another medications you use, especially:
· anakinra (Kineret);
· cyclophosphamide (Cytoxan, Neosar);
· sulfasalazine (Azulfidine); or
· drugs that weaken your immune system (such as cancer medication or steroids).
• This list is not complete and there may be another drugs that can interact with etanercept. Speak your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal commodity, and drugs predesigned by another doctors. Do not start a new medicine without telling your doctor.
• Your doctor or pharmacist can provide more information about etanercept.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
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