Etanercept (ee-TAN-er-sept)

Treats rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, juvenile psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Brand Name(s):

Enbrel, Enbrel Mini

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• 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 health provider 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.
• Allow the medicine to come to room temperature for 15 to 30 minutes before you use it. Do not shake it.
• 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.
• Prefilled cartridge, syringe, or autoinjector:
  • Do not remove the needle cap or cover from the cartridge, syringe, or autoinjector until you are ready to use it.
  • If the amount of liquid in the prefilled syringe does not fall between the purple indicator lines, do not use that syringe.
  • Push the door button on the AutoTouch™ reusable autoinjector and insert the Enbrel Mini™ prefilled cartridge. It should slide freely and completely into the door.
• Vial:
  • Mix the medicine with the liquid provided in your dose kit. Gently swirl the medicine to mix it.
  • Write the date you mixed the medicine on the sticker from the dose kit. Attach the sticker to the vial.
  • After your dose, put the unused mixture in the refrigerator right away. Do not mix vials together. Throw away any unused medicine after 14 days.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze.
• Keep this medicine in its original container. You may also store the medicine at room temperature for up to 14 days (vial) or 30 days (prefilled autoinjector, syringe, or cartridge). Do not put it back in the refrigerator once it has reached room temperature. Throw away any unused medicine that has been stored at room temperature after 14 days (vial) or 30 days (prefilled autoinjector, syringe, or cartridge). Do not store the medicine in extreme heat or cold (including keeping it inside your vehicle's glove box or trunk).
• Do not refrigerate the AutoTouch™ reusable autoinjector. Keep it at room temperature.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how etanercept work. Tell your doctor if you are using any of the following:
  • Abatacept, anakinra, cyclophosphamide
  • Diabetes medicine
  • Steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have diabetes, heart failure, liver problems (including hepatitis), multiple sclerosis or any nervous system problem, granulomatosis with polyangiitis, or a history of cancer, seizures, or Guillain-Barré syndrome. Tell your doctor if you are allergic to latex.
• This medicine may cause you to get infections more easily. Tell your doctor if you have any type of infection (including tuberculosis, hepatitis B) before you start treatment. Also tell your doctor if you or a family member has a history of tuberculosis (TB). Take precautions to avoid illness. Wash your hands often.
• This medicine may cause the following problems:
  • Increased risk of cancer, including lymphoma, leukemia, and skin cancer
  • Nervous system problems
  • New or worsening heart failure
  • Autoimmune problems, including lupus-like syndrome and autoimmune hepatitis
• You will need a skin test for TB before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a TB skin test.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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, red skin rash
• Change in how much or how often you urinate, painful or difficult urination
• Change in vision, eye pain
• Chest pain, coughing up blood, muscle pain, night sweats, weight loss
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Seizures
• Skin changes or growths, red, scaly patches on the skin
• Sores or white patches on your lips, mouth, or throat
• Swollen glands in your neck, armpits, or groin
• Trouble breathing, cold sweat, blue skin, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Pain, redness, swelling, itching, bleeding, or bruising where the shot was given

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