Etanercept-szzs (ee-TAN-er-sept - szzs)

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

Brand Name(s):

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 warm to room temperature for 15 to 30 minutes before you inject it. If the medicine in the syringe or pen has changed color, looks cloudy, or if you see large particles in it, do not use 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. Do not inject the medicine into areas where the skin is tender, bruised, red, hard, thick, scaly, has scars or stretch marks, or affected by psoriasis.
• Do not remove the needle cover from the syringe or pen until you are ready to use it. Do not shake the medicine.
• This medicine is available in 3 forms. You may use a prefilled syringe, prefilled Sensoready® pen, and vial.
• Use a new needle and syringe each time you inject your medicine.
• When using the Sensoready® Pen, the window in the pen turns green when the injection is complete. After removing the Sensoready® Pen, if the window has not turned green, or if it looks like the medicine is still injecting, it means you have not received a full dose. Call your doctor right away if this happens.
• 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 28 days (prefilled syringe or pen) or 31 days (vial). 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 28 days (prefilled syringe or pen) or 31 days (vial). Do not store the medicine in extreme heat or cold (including keeping it inside your vehicle's glove box or trunk).
• Vial: You may use the mixed liquid right away or keep it in the refrigerator for up to 14 days.
• 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-szzs work. Tell your doctor if you are using any of the following:
  • Abatacept, anakinra, cyclophosphamide, sulfasalazine
  • 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 kidney disease, liver problems (including hepatitis B), diabetes, heart disease, heart failure, psoriasis, 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 before you start treatment. Also tell your doctor if you or a family member has a history of tuberculosis (TB).
• 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
  • Serious skin reactions
• 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 check your progress and the effects of this medicine at regular visits. 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
• 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
• Swollen glands in your neck, armpits, or groin
• Trouble breathing, cold sweat, blue skin, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

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

• Diarrhea
• 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