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etanercept (cont.)

What should I discuss with my healthcare provider before using etanercept (Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick)?

You should not use this medication if you are allergic to etanercept, or if you have a severe infection such as sepsis (infection of the blood).

Some people using etanercept have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using etanercept or similar medicines to treat Crohn's disease or ulcerative colitis. However, people with autoimmune disorders (including psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

Before using etanercept, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure you can safely use etanercept, tell your doctor if you have any of these other conditions:

  • a weak immune system, or any type of infection including a skin infection or open sores;
  • diabetes;
  • congestive heart failure;
  • a nerve disorder such as multiple sclerosis, myelitis, or optic neuritis;
  • epilepsy or other seizure disorder;
  • asthma or other breathing disorder;
  • if you have ever had hepatitis B;
  • if you are allergic to latex rubber; or
  • if you are scheduled to receive any vaccines, or if you have recently been vaccinated with BCG (Bacille Calmette-Guerin).

FDA pregnancy category B. Etanercept is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether etanercept passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Children using this medication should be current on all childhood immunizations before starting treatment with etanercept.

How should I use etanercept (Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick)?

Before you start treatment with etanercept, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Etanercept is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes. You may need to mix etanercept with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

A child must weigh at least 138 pounds to use the Sureclick autoinjector. Children who weigh less than 138 pounds should use a different form of etanercept.

Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Avoid injecting into skin that is bruised, tender, red, or hard.

You may have pain, redness, swelling, or warmth where the medicine was injected. Call your doctor if these symptoms continue for longer than 5 days.

Use each disposable needle only one time. A single-use prefilled syringe or Sureclick autoinjector is for one injection only. Throw the used syringe or autoinjector away after one use, even if there is still medicine left in it. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Etanercept can lower blood cells that help your body fight infections. Your blood may need to be tested often. Serious and sometimes fatal infections may occur during treatment with etanercept. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using etanercept. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using etanercept.

Store this medication in the refrigerator. Do not freeze. After mixing etanercept with a diluent, store in the refrigerator and use it within 14 days. Do not use etanercept after the expiration date on the label has passed.

Do not shake the prefilled syringe. Vigorous shaking can ruin the medicine. Do not use the medication if it has changed colors or appears cloudy. Call your doctor for a new prescription.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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