Etanercept (Injection)

Introduction:

Etanercept (ee-TAN-er-sept)

Treats rheumatoid arthritis in adults and children. Also treats psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Brand Name(s):

Enbrel

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• 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.
• This powder medicine 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. Do not use if it is cloudy or has specks floating in it.
• If you are using one vial (bottle) for more than one dose of this medicine, use the "Mixing Date" stickers provided to write the date you mixed the medicine. Attach the sticker to the vial. Put the unused mixture in the refrigerator right away.
• Let the liquid medicine reach room temperature before you give yourself a shot (about 15 to 30 minutes). Do not remove the needle cover from the prefilled syringe while it is reaching room temperature.

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 has been mixed with the liquid, this mixture must be stored in the refrigerator. You must use this 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 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 kidney disease, liver disease, diabetes, cancer, congestive heart failure, psoriasis, or a blood disorder such as anemia. Tell your doctor if you have multiple sclerosis or any other nerve disorder. Make sure your doctor knows if you also have a history of hepatitis B infection, tuberculosis or if you have been in contact with someone who has tuberculosis, or if you have an infection that would not go away or keeps coming back.
• Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you 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 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 test.
• A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer. Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you 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.
• 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. Call your doctor right away if you start to have signs of infection such as 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 have been exposed to chickenpox or any other virus.
• Your risk of getting an infection increases when you travel to places where certain organisms (such as fungi, bacteria, viruses, or parasites) are more common. Tell your doctor where you live and if you have any history of travel if you start to have any sign of infection.
• If you are receiving the injection at home from a prefilled syringe, do not handle the needle cover if you are allergic to latex. The needle cover of the syringe contains latex.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Do not change or stop using this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
• 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 a 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.
• Tiredness.
• Upset stomach, diarrhea, or dry mouth.

If you notice other side effects that you think are caused by this medicine, tell your doctor: