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etanercept

Pronunciation

Generic Name: etanercept (ee TAN er sept)
Brand Name: Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick

What is etanercept?

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.

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

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

What is the most important information I should know about etanercept?

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.

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).

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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.

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

What should I discuss with my healthcare provider before using etanercept?

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?

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.

What happens if I miss a dose?

Call your doctor for instructions if you miss your etanercept 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 while using etanercept?

Do not receive a "live" vaccine while using etanercept, 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.

Etanercept side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using etanercept 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 etanercept 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 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)

Etanercept dosing information

Usual Adult Dose for Ankylosing Spondylitis:

25 mg subcutaneously twice weekly, 3 to 4 days apart. Alternatively, 50 mg subcutaneous doses may be given once a week on the same day.

Usual Adult Dose for Rheumatoid Arthritis:

25 mg subcutaneously twice weekly, 3 to 4 days apart. Alternatively, 50 mg subcutaneous doses may be given once a week on the same day.

Usual Adult Dose for Wegener's Granulomatosus:

25 mg subcutaneously twice weekly, 3 to 4 days apart. Alternatively, 50 mg subcutaneous doses may be given once a week on the same day.

Usual Adult Dose for Psoriatic Arthritis:

25 mg subcutaneously twice weekly, 3 to 4 days apart. Alternatively, 50 mg subcutaneous doses may be given once a week on the same day.

Usual Adult Dose for Still's Disease:

Study (n=12)
25 mg subcutaneously, twice to three times per week.

Usual Adult Dose for SAPHO Syndrome:

Case (n=1)
25 mg subcutaneously twice weekly, along with corticosteroid therapy.

Usual Adult Dose for Psoriasis:

Plaque Psoriasis:
Initial: 50 mg subcutaneously twice weekly (administered 3 to 4 days apart) for 3 months. Alternatively, starting doses of 25 mg to 50 mg per week have been shown to be effective.
Maintenance: 50 mg subcutaneously once weekly.

Usual Pediatric Dose for Uveitis:

3 years or older: 0.4 mg/kg/dose (to a maximum of 25 mg) subcutaneously, twice weekly.

Usual Pediatric Dose for Histiocytosis:

Case (n=1)
5 months or older: 0.4 mg/kg subcutaneously three times weekly.

Usual Pediatric Dose for Macrophage Activation Syndrome:

Case (n=1)
7 years or older: 0.4 mg/kg/dose subcutaneously twice weekly, for 11 weeks.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

4 years or older: 0.8 mg/kg/week (to a maximum of 50 mg per week) subcutaneously.

Child weight 31 to 62 kg (68 to 136 pounds): the total weekly dose should be administered as two (subcutaneous) injections, either on the same day or 3 to 4 days apart.

Child weight less than 31 kg (68 pounds): the dose should be administered as a single subcutaneous injection once weekly.

The maximum dose injected per site should not exceed 25 mg (1 mL).

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

Age 2 to 17 years with active polyarticular-course JIA:

Twice weekly dosing: 0.4 mg/kg/dose twice weekly given 72 to 96 hours apart
Maximum dose: 25 mg

Alternative once weekly dosing: 0.8 mg/kg/dose once weekly
Maximum: 50 mg per week

The 25 mg prefilled syringe is not recommended for pediatric patients weighing less than 31 kg (68 pounds). The 50 mg prefilled syringe or SureClick (TM) auto-injector may be used for pediatric patients weighing 63 kg (138 pounds) or more.

What other drugs will affect etanercept?

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 etanercept. 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.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about etanercept.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 13.01. Revision Date: 2011-09-13, 9:46:55 AM.

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