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Drug Information For:
ENBREL 25MG VIAL FOR INJ (4 VIALS)
Ingredient Name:ETANERCEPT (ee-TAN-er-sept)
Common Uses: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, certain types of skin 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.
Before Using This Medicine:WARNING: PATIENTS WHO USE THIS MEDICINE HAVE AN INCREASED RISK OF DEVELOPING SERIOUS AND SOMETIMES FATAL INFECTIONS such as bacterial, viral, or fungal infections, or tuberculosis (TB). Most patients who developed these infections were taking medicines that weakened their immune systems (eg, methotrexate, corticosteroids). 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, during, and after treatment with this medicine. If you have TB, you should begin to treat it before you begin treatment with this medicine. Tell your doctor if you have a history of persistent or recurring infections. CONTACT YOUR DOCTOR IMMEDIATELY if you develop signs of TB or any other type of infection (eg, persistent cough; muscle weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin; sores on your body; increased or painful urination). THIS MEDICINE IS A TNF-BLOCKER. Lymphoma and other types of cancer have been reported in children and teenagers treated with TNF-blockers. This has been fatal in some cases. Talk with your doctor for more information. 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, abatacept, anakinra, or tocilizumab. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking corticosteroids (eg, prednisone), insulin or other diabetes medicines (eg, metformin), or methotrexate. Tell your doctor if you are using medicine to treat an infection. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including any kind of infection; open cuts or sores on your body; flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin); numbness or tingling; a disease that affects your nervous system (eg, multiple sclerosis (MS), Guillain-Barre syndrome, seizures); conditions that may increase your risk of infection (eg, diabetes, HIV); allergies, including rubber or latex; pregnancy; or breast-feeding. Tell your doctor if you have a history of persistent or recurring infections, TB or a positive TB skin test, lymphoma or other cancers, liver problems (eg, hepatitis B), liver problems caused by drinking alcohol (alcoholic hepatitis), hepatitis B virus reactivation when taking this medicine or other TNF blockers, congestive heart failure, blood problems (eg, anemia), bone marrow problems, an autoimmune disorder (eg, lupus), immune system problems (eg, weakened immune system), rectalbleeding, shingles (herpes zoster), or Wegener granulomatosis. Tell your doctor if you have ever lived in or traveled to an area where TB is common, or if you live in or have traveled to certain parts of the country (eg, Ohio or Mississippi river valleys, the Southwest) where certain fungal infections (eg, blastomycosis, coccidioidomycosis, histoplasmosis) are common. Check with your doctor if you are not sure if you have lived in or have traveled to an area where these infections are common. Tell your doctor if you have been in close contact with someone who has had TB, if you have recently received a vaccine, or if you are scheduled to have 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 if you have Wegener granulomatosis and are taking a medicine that may weaken the immune system (eg, corticosteroids, methotrexate). Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use This Medicine:Follow the directions for taking this medicine provided by your doctor. This medicine comes with an extra patient information sheet called 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 given as an injection under the skin. IF YOU WILL BE USING THIS MEDICINE AT HOME, a health care provider will provide detailed instructions for its appropriate use. Be sure you understand how to use this medicine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Wash your hands with soap and warm water before using this medicine. Use an alcohol swab to clean the gray stopper on the vial. DO NOT touch the stopper with your hands. Mix this medicine as instructed by your health care provider. DO NOT SHAKE this medicine. If all the powder in the vial is not dissolved or if there are particles present after 10 minutes, do not inject. Contact your health care provider. DO NOT USE THIS MEDICINE if it is cloudy, discolored, contains particles, or if the vial is cracked or damaged in any way. 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. THE SYRINGE, NEEDLES, AND VIAL ADAPTER should never be reused. Never recap a needle. USE THE PROPER TECHNIQUE taught to you by your doctor. Inject deep under the skin, NOT into muscle. IT MAY TAKE SEVERAL WEEKS FOR THIS MEDICINE TO WORK. Do not exceed the recommended dose, stop using this medicine, or use for longer than prescribed without checking with your doctor. DO NOT RECEIVE A LIVE VACCINE (eg, measles, mumps) or treatment with a weakened bacteria (eg, BCG for bladder cancer) while you are taking this medicine. Talk with your doctor before you receive any vaccine. Before you use this medicine, discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations. STORE THE UNMIXED MEDICINE in its dose tray in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). THE MIXED MEDICINE may be stored in the refrigerator between 36 to 46 degrees F (2 and 8 degrees C) for up to 14 days. Do not freeze. Discard mixed solution after 14 days. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and away from pets. DO NOT MISS ANY DOSES of this medicine. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor immediately.
Cautions:DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. Check with your health care provider if you are allergic to latex. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS. THIS MEDICINE MAY INTERFERE WITH CERTAIN LAB TESTS. Make sure laboratory personnel and your doctors know you use 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. THIS MEDICINE MAY LOWER YOUR RESISTANCE TO INFECTION. Avoid contact with people who have colds or infections. THIS MEDICINE MAY INCREASE THE RISK OF DEVELOPING BLOOD CANCER (eg, leukemia, lymphoma) AND OTHER TYPES OF CANCER. This may be fatal in some cases. Tell your doctor if you have ever had cancer. Contact your doctor right away if you develop any unusual symptoms, such as unusual bruising, unusual lumps or swelling (eg, in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness or weakness, unexplained cough or shortness of breath, persistent unexplained itching, or unexplained weight loss. NEW OR WORSENING NERVOUS SYSTEM DISORDERS (eg, multiple sclerosis / MS, Guillain-Barre syndrome, seizures) have occurred in patients that take this medicine. Tell your doctor if you have a disease that affects your nervous system. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. IF YOU HAVE NOT HAD CHICKENPOX, SHINGLES, OR MEASLES, avoid contact with anyone who does. IF YOU DEVELOP any symptoms of TB (eg, 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. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN; they may be at increased risk for developing certain types of cancer with this medicine, which may be fatal. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine. FOR WOMEN: IF YOU BECOME PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. If you used this medicine during pregnancy, tell your baby's doctor. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while using this medicine. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugarlevels closely and ask your doctor before adjusting the dose of your diabetes medicine.
Possible Side Effects:SIDE EFFECTS that may occur while taking this medicine include dizziness; headache; mild pain, redness, itching, bruising, or swelling around the injection site. If they continue or are bothersome, check with your doctor. SOME PATIENTS who use this medicine have developed new or worsening psoriasis. Tell your doctor right away if you notice any new or worsening skin problems (eg, red, flaky, or itchy skin patches). A RARE TYPE OF CANCER called HSTCL has been reported in patients using TNF blockers. These cases have been fatal. Most of these cases occurred in teenagers or young adults. Most of these patients had Crohn disease or ulcerative colitis. Patients who developed this cancer were usually using this medicine along with certain other medicines (azathioprine, 6-mercaptopurine). Tell your doctor if you have or have ever had any type of cancer. Tell your doctor right away if you develop stomach pain or tenderness, fever, night sweats, or unexplained weight loss. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blood in the urine or stools; burning, numbness, or tingling; butterfly rash (rash on nose and cheeks); change in the appearance of a mole; chest pain or discomfort; dark, tarry, or bloody stools; decreased mental alertness; fast heartbeat; fever, chills, or sore throat; general feeling of being unwell; increased or painful urination; mental/mood changes; new or worsening cough; open sore that does not heal; rapid breathing; rash on your face and arms that gets worse in the sun; red, swollen, peeling, or blistered skin; seizures; shortness of breath; sudden, unexplained weight gain; swelling of the arms or legs; swelling of the lymph nodes; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools); unusual bruising or bleeding; unusual lumps; unusual nausea, vomiting, stomach pain, or diarrhea; unusual skin growth or other skin changes; unusual tiredness or weakness; unusually pale skin; vision problems; or weakness in the 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; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. 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.
Overdose:If overdose is suspected, contact your local poison control center or emergency room immediately.
Additional Information:DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. 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. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2014 Wolters Kluwer Health, Inc.