Learn more about usage, cautions, and possible side effects .
Chemical Name: ETANERCEPT (et-a-NER-sept)
This medicine is a type of protein called a tumor necrosis factor (TNF) inhibitor used to treat moderate to severe forms of ankylosing spondylitis (AS), juvenile arthritis, psoriasis, and rheumatoid and psoriatic arthritis. This medicine may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.
WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS (eg, bacterial sepsis, tuberculosis) have occurred in patients using this medicine. Tuberculosis (TB) may be caused by a new infection or by reactivation of a previous infection. Your doctor will test you for TB and evaluate your risk for developing it. This will occur before and during treatment with this medicine. If you have TB, you should begin to treat it before you begin treatment with this medicine. CONTACT YOUR DOCTOR RIGHT AWAY if you develop chest pain or discomfort; decreased mental alertness; fast heartbeat; fever, chills, or sore throat; general feeling of being unwell; new or worsening cough; rapid breathing; shortness of breath; swelling of the lymph nodes; or unusual diarrhea, nausea, stomach pain, or vomiting. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE IF you are taking cyclophosphamide. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking costimulation modulators (eg, abatacept), interleukin-1 receptor antagonist (eg, anakinra), cyclophosphamide, amphetamines (eg, dextroamphetamine), decongestants (eg, pseudoephedrine), lithium, salicylates (eg, aspirin), or sulfonylureas (eg, glipizide). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including if you have any kind of infection, including an infection that is in only one place in your body (such as an open sore), or an infection that is in your whole body (such as the flu); a history of infections that keep coming back, conditions that may increase your risk of infection (eg, diabetes), or live in or have traveled to areas where fungal infections (eg, histoplasmosis) are common; a history of TB, a positive TB skin test, or if you have been in close contact with someone who has had TB; any numbness or tingling or a disease that affects your nervous system (eg, multiple sclerosis [MS]); congestive heart failure; a blood disease; any lupus-like disease; rectal bleeding; shingles (herpes zoster); Wegener granulomatosis; a history of lymphoma or cancer; allergies to medicines, foods, rubber or latex; pregnancy; or breast-feeding. Tell your doctor if you are scheduled to have major surgery or any kind of vaccination. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have an infection that has spread throughout your entire body (sepsis), or Wegener granulomatosis and are taking a medicine that may weaken the immune system (eg, corticosteroids, methotrexate). Use of this medicine in children under age 2 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
Follow the directions for taking this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine is usually administered as an injection at your doctor's office, hospital, or clinic. This medicine is sometimes used at home as an injection. IF YOU ARE USING THIS MEDICINE AT HOME, a healthcare professional will provide detailed instructions for its appropriate use. Ask them any questions that you may have about your medicine or giving injections. DO NOT USE THIS MEDICINE if it is cloudy or discolored, contains particles, or if the syringe is cracked or damaged in any way. Wash your hands with soap and warm water before using this medicine. Remove one prefilled syringe of this medicine from the refrigerator. Wait 15 to 30 minutes to allow the medicine in the prefilled syringe to reach room temperature. DO NOT shake the syringe. DO NOT REMOVE the needle cover while allowing it to reach room temperature. DO NOT warm this medicine in any other way (eg, in a microwave or in hot water). Rotate the site for each injection. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, try not to inject directly into any raised, red, thick, or scaly skin patches. STORE THIS MEDICINE in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep the prefilled syringes in the original carton to protect them from light until the time of use. Do not miss any doses of this medicine. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor right away to find out when to take your next dose.
DO NOT USE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. IT MAY TAKE SEVERAL WEEKS for this medicine to work. Do not stop using this medicine without checking with your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE MAY REDUCE THE NUMBER OF BLOOD CELLS THAT ARE NEEDED FOR CLOTTING. To prevent bleeding, avoid situations where bruising or injury may occur. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools. THIS MEDICINE MAY LOWER YOUR RESISTANCE TO INFECTION. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Tell your doctor right away if you notice signs of infection like chest pain or discomfort; chills, fever, or sore throat; decreased mental alertness; fast heartbeat; general feeling of being unwell; new or worsening cough; rapid breathing; shortness of breath; swelling of the lymph nodes; or unusual diarrhea, nausea, stomach pain, or vomiting. THIS MEDICINE MAY INCREASE THE RISK OF DEVELOPING LYMPHOMA (BLOOD CANCER) OR OTHER TYPES OF CANCER. Discuss any questions or concerns with your doctor. Tell your doctor if you have ever had cancer. Contact your doctor right away if you develop symptoms of lymphoma such as unusual lumps or swelling (eg, in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness or weakness, persistent unexplained itching, or unexplained weight loss. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. Before you use this medicine, discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations. DO NOT RECEIVE A LIVE VACCINE (eg, measles, mumps) while you are taking this medicine. Talk with your doctor before you receive any vaccine. IF YOU HAVE NOT HAD CHICKENPOX, SHINGLES, OR MEASLES, avoid contact with anyone who does. Contact your doctor if you come into contact with these infections. IF YOU DEVELOP any of the symptoms of TB (eg, a dry cough that does not go away, fever, night sweats, weight loss), call your doctor. You will need to be examined for TB and have a skin test. The needle cover of the prefilled syringe contains natural rubber (latex) which may cause allergic reactions in individuals sensitive to this substance. Tell your doctor if you are allergic to rubber or latex. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine, especially the risk of developing infections. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while using this medicine.
SIDE EFFECTS that may occur while taking this medicine include dizziness; headache; pain, redness, itching, bruising, or swelling around the injection site. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience butterfly rash (rash on nose and cheeks); chest pain or discomfort; dark, tarry, or bloody stools, decreased mental alertness; fast heartbeat; fever, chills, or sore throat; general feeling of being unwell; mental/mood changes; new or worsening cough; numbness or tingling throughout your body; rapid breathing; rash on your face and arms that gets worse in the sun; seizures; shortness of breath; swelling of arms or legs; swelling of the lymph nodes; unusual bruising or bleeding; unusual lumps; unusual nausea, vomiting, stomach pain, or diarrhea; unusual tiredness; vision problems; or weakness in arms or legs. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
If overdose is suspected, contact your local poison control center or emergency room immediately.
YOU MAY SEE IMPROVEMENT OF YOUR SYMPTOMS as soon as 1 to 2 weeks after starting this medicine. Up to 3 months of treatment may be needed for some patients. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.
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