Enbrel Multiple-Use VialsPronunciation
Generic Name: etanercept (ee-TAN-er-sept)
Brand Name: Enbrel Multiple-Use Vials
Patients who use Enbrel Multiple-Use Vials have an increased risk of developing serious and sometimes fatal infections (eg, bacterial, viral, fungal infections; tuberculosis [TB]). Most patients who developed these infections were taking medicines that weakened their immune systems (eg, corticosteroids, methotrexate).
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 of developing it. This will occur before, during, and after treatment with Enbrel Multiple-Use Vials. If you have TB, you should begin to treat it before you begin treatment with Enbrel Multiple-Use Vials. 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).
Enbrel Multiple-Use Vials is a tumor necrosis factor (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.
Enbrel Multiple-Use Vials is used for:
Treating moderate to severe forms of ankylosing spondylitis (AS), juvenile arthritis, certain types of skin psoriasis, and rheumatoid and psoriatic arthritis. Enbrel Multiple-Use Vials may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.
Enbrel Multiple-Use Vials is a TNF blocker. It works by blocking a protein (TNF-alpha) found in the body that causes inflammation.
Do NOT use Enbrel Multiple-Use Vials if:
- you are allergic to any ingredient in Enbrel Multiple-Use Vials
- you have an infection that has spread throughout your entire body (sepsis)
- you have Wegener granulomatosis and are taking a medicine that may weaken the immune system (eg, corticosteroids, methotrexate)
- you are taking cyclophosphamide, abatacept, anakinra, or tocilizumab
Contact your doctor or health care provider right away if any of these apply to you.
Before using Enbrel Multiple-Use Vials:
Some medical conditions may interact with Enbrel Multiple-Use Vials. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances (including latex or rubber)
- if you have 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), or are using medicine to treat an infection
- if you have a history of persistent or recurring infections, have conditions that may increase your risk of infection (eg, diabetes, HIV), or 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
- if you have a history of TB or a positive TB skin test, if you have ever lived in or traveled to an area where TB is common, or if you have been in close contact with someone who has had TB
- if you have any numbness or tingling or a disease that affects your nervous system (eg, multiple sclerosis [MS], Guillain-BarrÃ© syndrome, seizures)
- if you have a history of congestive heart failure, lymphoma or other cancers, a blood problem (eg, anemia), bone marrow problems, an autoimmune disorder (eg, lupus), immune system problems (eg, weakened immune system), rectal bleeding, shingles (herpes zoster), or Wegener granulomatosis
- if you have a history of liver problems (eg, hepatitis B), liver problems caused by drinking alcohol (alcoholic hepatitis), or hepatitis B virus reactivation when taking Enbrel Multiple-Use Vials or other TNF blockers
- if you are scheduled to have surgery or any kind of vaccination, or have recently received a vaccine
Some MEDICINES MAY INTERACT with Enbrel Multiple-Use Vials. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Corticosteroids (eg, prednisone), costimulation modulators (eg, abatacept), interleukin-1 receptor antagonists (eg, anakinra), methotrexate, or tocilizumab because the risk of serious infections may be increased
- Cyclophosphamide because the risk of developing cancer may be increased
- Insulin or other diabetes medicines (eg, metformin) because the risk of low blood sugar may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Enbrel Multiple-Use Vials may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Enbrel Multiple-Use Vials:
Use Enbrel Multiple-Use Vials as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Enbrel Multiple-Use Vials comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Enbrel Multiple-Use Vials refilled.
- Enbrel Multiple-Use Vials is given as an injection under the skin. If you will be using Enbrel Multiple-Use Vials at home, a health care provider will teach you how to use it. Be sure you understand how to use Enbrel Multiple-Use Vials. 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 Enbrel Multiple-Use Vials.
- Use an alcohol swab to clean the gray stopper on the vial. Do not touch the stopper with your hands.
- Do not shake Enbrel Multiple-Use Vials.
- Do not use Enbrel Multiple-Use Vials if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- If all the powder in the vial is not dissolved or there are particles present after 10 minutes, do not inject. Contact your health care provider.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
- 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.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- Do not miss any doses of Enbrel Multiple-Use Vials. If you miss a dose of Enbrel Multiple-Use Vials, contact your doctor right away to find out when to take your next dose.
Ask your health care provider any questions you may have about how to use Enbrel Multiple-Use Vials.
Important safety information:
- Enbrel Multiple-Use Vials may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Enbrel Multiple-Use Vials with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Enbrel Multiple-Use Vials may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. 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.
- Enbrel Multiple-Use Vials may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Enbrel Multiple-Use Vials may increase the risk of developing blood cancer (eg, leukemia, lymphoma) and other types of cancer. This may be fatal in some cases. 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 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.
- 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 Enbrel Multiple-Use Vials 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.
- New or worsening nervous system disorders (eg, MS, Guillain-BarrÃ© syndrome, seizures) have occurred in patients who take Enbrel Multiple-Use Vials. Tell your doctor if you have a disease that affects your nervous system. Discuss any questions or concerns with your doctor.
- Some patients who use Enbrel Multiple-Use Vials 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).
- 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.
- Before you use Enbrel Multiple-Use Vials, 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) or treatment with a weakened bacteria (eg, BCG for bladder cancer) while you are taking Enbrel Multiple-Use Vials. Talk with your doctor before you receive any vaccine.
- It may take several weeks for Enbrel Multiple-Use Vials to work. Do not stop using Enbrel Multiple-Use Vials without checking with your doctor.
- Tell your doctor or dentist that you take Enbrel Multiple-Use Vials before you receive any medical or dental care, emergency care, or surgery.
- If you develop any 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.
- Diabetes patients - Enbrel Multiple-Use Vials may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- If you used Enbrel Multiple-Use Vials while you were pregnant, tell your baby's doctor.
- Enbrel Multiple-Use Vials may interfere with certain lab tests, including tests for TB infection. Be sure your doctor and lab personnel know you are using Enbrel Multiple-Use Vials.
- Use Enbrel Multiple-Use Vials with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of developing infections.
- Caution is advised when using Enbrel Multiple-Use Vials in CHILDREN; they may be at increased risk of developing certain types of cancer, which may be fatal.
- Enbrel Multiple-Use Vials should be used with extreme caution in CHILDREN younger than 2 years old or in children with plaque psoriasis if they are younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Enbrel Multiple-Use Vials while you are pregnant. It is not known if Enbrel Multiple-Use Vials is found in breast milk. Do not breast-feed while using Enbrel Multiple-Use Vials.
Possible side effects of Enbrel Multiple-Use Vials:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; headache; mild pain, redness, itching, bruising, or swelling around the injection site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blood in the urine or stools; burning, numbness, or tingling; butterfly rash (rash on your nose and cheeks); change in the appearance of a mole; chest pain or discomfort; decreased mental alertness; fast heartbeat; fever, chills, or sore throat; general feeling of being unwell; increased or painful urination; mental or 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, blistered, or peeling 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; weakness in the arms or legs.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Enbrel Multiple-Use Vials:
Store the unmixed medicine in its dose tray in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Enbrel Multiple-Use Vials out of the reach of children and away from pets.
The mixed medicine may be stored in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C) for up to 14 days. Do not freeze. Discard mixed solution after 14 days. Keep Enbrel Multiple-Use Vials out of the reach of children and away from pets.
- If you have any questions about Enbrel Multiple-Use Vials, please talk with your doctor, pharmacist, or other health care provider.
- Enbrel Multiple-Use Vials is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Enbrel Multiple-Use Vials or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Enbrel Multiple-Use Vials. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Enbrel Multiple-Use Vials. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Enbrel Multiple-Use Vials.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.