Treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults. Also treats juvenile idiopathic arthritis in children.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not use this medicine if you have had an allergic reaction to etanercept, or if you have sepsis (a serious infection in your blood).
How to Use This Medicine
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
- This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
- Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
- A nurse or other trained health professional will give you this medicine.
- You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
- Use a new needle and syringe each time you inject your medicine.
- You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
- To use the vial (glass container):
- The powder medicine in the vial must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it.
- Do not shake the medicine after it has been mixed.
- The mixture should be clear and colorless, and may have some small white particles. If it is cloudy, discolored, or has large particles, do not use it.
- Let the liquid mixture reach room temperature before you give yourself a shot. This takes about 15 to 30 minutes.
- If you are using one vial for more than one dose, use the "Mixing Date" stickers from the dose kit to write the date you mixed the medicine. Attach the sticker to the vial.
- Put the unused mixture in the refrigerator right away. Do not mix the contents of one vial with another vial. Throw away any unused medicine after 14 days.
- To use the prefilled syringe or autoinjector:
- Remove the carton with the syringe or autoinjector from the refrigerator and place it on a clean cloth.
- Let the syringe or autoinjector reach room temperature before you give yourself a shot. This takes about 15 to 30 minutes. Do not shake the medicine.
- Do not remove the needle cover from the syringe or autoinjector while it is warming to room temperature. Remove these right before use.
- Check the liquid in the syringe or autoinjector. It should be clear and colorless, and may have some small white particles. If it is cloudy, discolored, or has large particles, do not use it.
- Check that the amount of liquid in the prefilled syringe falls between the two purple fill level indicator lines on the syringe. If the syringe does not have the right amount of liquid, do not use it.
If a dose is missed:
- Call your doctor or pharmacist for instructions.
How to Store and Dispose of This Medicine
- If you store this medicine at home, keep it in the refrigerator. Do not freeze.Do not freeze.
- Once the powder medicine in the vial has been mixed with the liquid, the mixture must be stored in the refrigerator. You must use the mixture within 14 days. After 14 days, throw away any leftover mixture.
- Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are using medicines that weaken your immune system. These include azathioprine (Imuran®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, Decadron®, Medrol®, Orasone®, or Prelone®) or medicines that treat cancer (such as cyclophosphamide, methotrexate, Cytoxan®, or Taxol®). Tell your doctor if you are also using abatacept (Orencia®), anakinra (Kineret®), or sulfasalazine (Azulfidine®) to treat arthritis.
- Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.
Warnings While Using This Medicine
- Make sure your doctor knows if you are pregnant or breastfeeding, or if you have diabetes, a history of cancer, congestive heart failure, eye problems, psoriasis, or a blood disorder such as anemia. Tell your doctor if you have Guillain-Barré syndrome, multiple sclerosis, a history of seizures, or any other nervous system problem. Make sure your doctor knows if you also have alcoholic hepatitis, a history of hepatitis B infection, tuberculosis, Wegener's granulomatosis, or contact with someone who has tuberculosis, or if you have an infection that keeps coming back.
- This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you or your child have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you receive the medicine.
- Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in your mouth or lips; or unusual tiredness or weakness.
- You or your child will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
- A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer (such as leukemia). Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you or your child have unusual bleeding, bruising, or weakness; swollen lymph nodes in the neck, underarms, or groin; or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.
- Serious nervous system problems, including Guillain-Barré syndrome, multiple sclerosis, demyelinating disease, and seizures have occurred rarely in people using this medicine. Talk with your doctor if you have concerns about this.
- This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
- You may get infections more easily while you are using this medicine. Avoid people who are sick or have infections. Stop using this medicine and call your doctor right away if you or your child start to have signs of infection such as a persistent cough, weight loss, night sweats, fever or chills, shortness of breath, or flu-like symptoms such as a runny or stuffy nose, headache, or feeling generally ill. Tell your doctor if you or your child have been exposed to chickenpox or any other virus.
- This medicine may increase your risk of having a lupus-like syndrome or autoimmune hepatitis. Stop using this medicine and check with your doctor right away if you or your child have fever or chills; general feeling of discomfort, illness, or weakness; light-colored stools; nausea and vomiting; upper right abdominal or stomach pain; or yellow eyes and skin.
- Check with your doctor right away if you have more than one of these symptoms: shortness of breath; swelling of the face, fingers, feet, or lower legs; or sudden weight gain. These may be signs of a heart condition called congestive heart failure (CHF).
- If you are receiving the injection at home from a prefilled syringe or the Sureclick? autoinjector, do not handle the needle covers if you are allergic to latex. The needle covers on the syringe and autoinjector contain latex.
- Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
- Blistering, peeling, or red skin rash.
- Bone pain.
- Blurred vision or sudden change in vision.
- Change in how much or how often you urinate, or painful urination.
- Chest pain or coughing up blood.
- Fever, chills, cough, hoarseness, runny or stuffy nose, or sore throat.
- Lightheadedness, fainting, seizure, or trouble thinking.
- Lumps in your neck, armpits, or groin.
- Numbness or weakness in your arm or leg, or on one side of your body.
- Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
- Pain in your lower leg (calf).
- Raised bumps on the skin filled with pus.
- Red or black stools.
- Red, scaly patches on the skin.
- Shortness of breath, cold sweat, and bluish-colored skin.
- Sores or white patches on your lips, mouth, or throat.
- Sudden and severe stomach pain, nausea, and vomiting.
- Sudden or severe headache, or problems with vision, speech, or walking.
- Swelling in your hands, ankles, or feet.
- Unexplained weight loss.
- Unusual bleeding, bruising, pale skin, or weakness.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Depression, or mood or behavior changes.
- Mild headache or dizziness.
- Mild skin rash or itching.
- Pain, redness, swelling, itching, bleeding, or bruising of your skin where the shot was given.
- Sudden weight gain or weight loss.
- Upset stomach, diarrhea, or dry mouth.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Review Date: 2011-02-04
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