enbrel

Enbrel (etanercept) works by decreasing a certain protein produced by the immune system. The immune system helps the body fight infections. In people with autoimmune disorders, the immune system mistakes the body"s own cells for invaders and attacks them.

Enbrel is used to treat the symptoms of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, and to prevent joint damage caused by these conditions. Enbrel is also used to treat plaque psoriasis in adults and polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.

Enbrel may also be used for purposes not listed in this medication guide.

Important information

Some people using Enbrel 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 Enbrel or similar medicines to treat Crohn"s disease or ulcerative colitis. Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

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

Before using Enbrel

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

See also: Pregnancy and breastfeeding warnings (in more detail)

How should I use Enbrel?

Before you start treatment with Enbrel, 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.

Enbrel 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 Enbrel 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 Enbrel.

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 Enbrel 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 Enbrel 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.

Enbrel 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 Enbrel. 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 Enbrel, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Enbrel. Visit your doctor regularly.

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

Store Enbrel in the refrigerator. Do not freeze. After mixing Enbrel with a diluent, store in the refrigerator and use it within 14 days. Do not use Enbrel 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.

What happens if I miss a dose?

Call your doctor for instructions if you miss your Enbrel dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Do not receive a "live" vaccine while using Enbrel, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox.

Enbrel side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Enbrel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Enbrel and call your doctor right away if you have any of these symptoms of lymphoma:

• fever, night sweats, weight loss, tiredness;

• feeling full after eating only a small amount;

• pain in your upper stomach that may spread to your shoulder;

• easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Stop using Enbrel and call your doctor at once if you have any of these other serious side effects:

• signs of infection (fever, chills, sore throat, body aches, confusion, neck stiffness, flu symptoms);

• shortness of breath with swelling, rapid weight gain;

• chest pain, ongoing cough, coughing up mucus or blood;

• signs of skin infection such as itching, swelling, warmth, redness, or oozing;

• black, bloody, or tarry stools;

• changes in mood or personality (in children);

• numbness, burning, pain, or tingly feeling;

• joint pain or swelling with fever, swollen glands, muscle aches, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or

• patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious Enbrel side effects may include:

• mild nausea, vomiting, mild diarrhea, mild stomach pain;

• runny or stuffy nose, cold symptoms; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Enbrel?

Tell your doctor about all other medications you use, especially:

• anakinra (Kineret);

• cyclophosphamide (Cytoxan, Neosar);

• sulfasalazine (Azulfidine); or

• drugs that weaken your immune system (such as cancer medicine or steroids).

This list is not complete and there may be other drugs that can interact with Enbrel. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.