Uses

What is Enbrel used for?

Enbrel (etanercept) is commonly used for the following conditions.

Learn more about Enbrel for Rheumatoid Arthritis.

Enbrel may also be used for other conditions as determined by your healthcare provider.

How does Enbrel work (mechanism of action)?

Enbrel blocks a substance in the body called tumor necrosis factor (TNF) from working. People with certain conditions, like rheumatoid arthritis and plaque psoriasis, have too much TNF activity. This can cause swelling (inflammation) in parts of the body. Blocking TNF from working can decrease the swelling that causes these conditions.

How is Enbrel supplied (dosage forms)?

Enbrel is available in the following dosage forms that are injected under the skin (subcutaneous).

  • 25 mg/0.5 mL solution for injection, prefilled syringe and vial
  • 50 mg/mL solution for injection, prefilled syringe, prefilled autoinjector (SureClick), prefilled cartridge for use with AutoTouch autoinjector (Enbrel Mini)

How should I store Enbrel?

Multiple-Dose Vials. Enbrel multiple-dose vials should be kept in their original tray to protect them from light. They should be stored in the refrigerator, between 36 F to 46 F (2 C to 8 C). Do not shake or freeze the medicine. These vials can be stored at room temperature up to 77 F (25 C) for up to 14 days, if needed. Once stored at room temperature, they cannot be placed back into the refrigerator. If not used within 14 days, they should be thrown away. 

Once a multiple-dose vial has been mixed with the provided liquid (which comes in a syringe), the dose should either be used right away or stored in the refrigerator for no more than 14 days.

All Other Dosage Forms. Enbrel should be kept in its original carton to protect it from light. It must be stored in the refrigerator, between 36 F to 46 F (2 C to 8 C). Do not shake or freeze the medicine. Enbrel prefilled syringes, prefilled autoinjectors, single-dose vials, or prefilled cartridges can be stored at room temperature up to 77 F (25 C) for up to 30 days, if needed. Once stored at room temperature, they cannot be placed back into the refrigerator. If not used within 30 days, they should be thrown away. 

In some cases, a special device called a reusable autoinjector is used to administer a dose of Enbrel. If you have a reusable autoinjector, do not store it in the refrigerator with your medicine. Instead, it should be kept in a safe place out of the reach of children at room temperature. 

Side Effects

What are the most common side effects of Enbrel?

The most common side effects of Enbrel are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Infection (see below)
  • Pain, itching, swelling, or redness near the injection site

There may be other side effects of Enbrel that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Enbrel?

While less common, the most serious side effects of Enbrel are described below, along with what to do if they happen.

Severe Allergic Reactions. Enbrel may cause allergic reactions, which can be serious. Stop using Enbrel and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infection. Enbrel can increase the risk of infections, including serious infections. It can also make current infections worse. Call your healthcare provider if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Cough or coughing up blood
  • Feeling very tired
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Warm, red, or painful skin or sores on your body
  • Weight loss

Reactivated Infections. Some types of microbes that cause infections (such as bacteria or viruses) can remain in the body after you recover from the infection. When a microbe stays in the body but does not cause an infection, it is called a “latent” microbe. Enbrel may increase your risk of reactivating a latent microbe, causing an infection. Before you start treatment with Enbrel, let your healthcare provider know if you have ever had tuberculosis (TB), hepatitis B, or any other serious infections.

Cancer. A small number of people who used Enbrel have developed cancer. Children and teenagers who use Enbrel may have an increased risk of developing cancer. People with severe rheumatoid arthritis who use Enbrel may also have an increased risk of a certain type of cancer called lymphoma. Let your healthcare provider know if you or your family has a history of cancer. 

Blood Disorders. Enbrel can cause blood disorders, such as agranulocytosis, aplastic anemia, hemolytic anemia, low platelet levels (thrombocytopenia), and low white blood cell levels (leukopenia). Stop using Enbrel and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Heart Failure. Enbrel may increase your risk of developing heart failure. If you already have heart failure, it may make your heart failure worse. Tell your healthcare provider right away if you have any of the following symptoms of heart failure. If you already have heart failure, tell your healthcare provider right away if any of these symptoms have gotten worse.

  • Shortness of breath or trouble breathing, especially while lying down
  • Swelling in your feet, ankles, or legs
  • Unusually fast weight gain
  • Unusual tiredness

Immune System Reactions. Enbrel can cause inflammation of your liver, blood vessels, or lymph vessels and cause symptoms that look like a condition called lupus. It can also cause inflammation in the liver, leading to a condition known as autoimmune hepatitis. Stop using Enbrel and call your healthcare provider right away if you develop any of the following symptoms.

  • Rash
  • Joint pain
  • Fever
  • Weakness or unusual tiredness
  • Skin or eyes look yellow (also called jaundice)
  • Poor appetite
  • Vomiting
  • Pain on the right side of the stomach

Nerve Damage. In rare cases, Enbrel may cause damage to the protective covering that surrounds the nerves (demyelinating disease). Tell your healthcare provider if you already have a demyelinating disease before starting Enbrel, such as multiple sclerosis or optic neuritis, or if you have seizures. Once you have started using Enbrel, tell your healthcare provider right away if you have any of the following symptoms.

  • Changes in mental function
  • Muscle weakness
  • Numbness or tingling
  • Poor coordination or dizziness
  • Trouble walking
  • Vision changes or vision loss

Warnings & Precautions

Who should not use Enbrel?

Allergies to Ingredients. People who are allergic to any of the following should not use Enbrel.

  • Enbrel
  • Etanercept
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Enbrel.

An Infection That Has Spread Throughout the Body (Sepsis). Sepsis occurs when the body has a life-threatening response to a serious infection. Anyone who has sepsis should not use Enbrel.

What should I know about Enbrel before using it?

Do not use Enbrel unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Do not share Enbrel with other people, even if they have the same condition as you. It may harm them.

Keep Enbrel out of the reach of children. Since this medicine must be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator. If you use a special device called a reusable autoinjector to give your Enbrel dose, this should also be kept out of the reach of children. However, it should be stored at room temperature instead of in the refrigerator.

This medicine is injected under the skin. Make sure that you or a caregiver understands how to properly prepare and use Enbrel. If you have any questions, talk to your healthcare provider.

What should I tell my healthcare provider before using Enbrel?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Enbrel is right for you.

In particular, make sure that you discuss any of the following.

Risk for Infection. Before starting Enbrel, it is important to talk to your healthcare provider about any serious infections you have had in the past as well as any infections you have currently. You should also let your healthcare provider know if you have any of the following issues that might increase your chance of having an infection.

  • A current infection or any symptoms of an infection
  • History of a fungal infection, such as histoplasmosis
  • History of tuberculosis (TB)
  • Have a weak immune system or a history of infections coming back often
  • Been in close contact with someone who has TB
  • Recent exposure to someone with chickenpox (varicella)
  • Living in, have lived in, or traveled to countries where there is a risk for TB
  • Living in or traveled to the Ohio or Mississippi River valleys or the Southwest United States

Other Medicines and Supplements. Enbrel may interact with other medicines and supplements. Before using Enbrel, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Vaccines. Let your healthcare provider know if you have recently received or are scheduled to receive any vaccines. There are certain vaccines (live vaccines) that you should not receive either right before receiving Enbrel or once you have started using Enbrel. Your healthcare provider will confirm whether any upcoming vaccines are safe.

Pregnancy. It is not known if or how Enbrel could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Enbrel while you are pregnant or trying to get pregnant. If you used Enbrel while pregnant, talk to your healthcare provider about any vaccines your infant may need to receive.

Breastfeeding. Enbrel passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Enbrel while breastfeeding.

How can I get more information about Enbrel?

For more information about Enbrel, you can visit the manufacturer’s website at www.enbrel.com or call them at 888-4ENBREL (888-436-2735).

Interactions

Does Enbrel interact with foods or drinks?

There are no known interactions between Enbrel and foods or drinks.

It is unknown if drinking alcohol will affect Enbrel.

Does Enbrel interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Enbrel.

  • A medicine for diabetes
  • Abatacept (Orencia), which is used for certain autoimmune conditions
  • Anakinra (Kineret), which is used for rheumatoid arthritis and other conditions
  • Cyclophosphamide (Cytoxan), which is used for certain autoimmune conditions
  • Sulfasalazine (Azulfidine), which is used for rheumatoid arthritis and ulcerative colitis

This may not be a complete list of medicines that can interact with Enbrel. Always check with your healthcare provider.

Does Enbrel (etanercept) interact with other drugs you are taking?
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Overdose/Missed Dose

What should I do if I accidentally use too much Enbrel?

If you or someone else has used too much Enbrel, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Enbrel?

If you miss a dose, take it as soon as you remember. Then take your next dose at the regularly scheduled time. If your dose is very late, call your pharmacist or other healthcare provider to discuss whether you should take the missed dose.

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