Enbrel (Etanercept) – Subcutaneous

Warning:

Prescribing information for Enbrel (etanercept) contains a boxed warning for the increased risk of serious infections during treatment. You may be tested for tuberculosis (TB) before starting treatment with Enbrel. If you test positive, you must be treated for TB prior to starting Enbrel.

Enbrel is a tumor necrosis factor (TNF) blocker. The boxed warning also advises that lymphoma and other malignancies have been reported in children and adolescents using TNF blockers.

What Is Enbrel?

Enbrel (etanercept) is a tumor necrosis factor (TNF) receptor blocker used to treat several autoimmune conditions, such as rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and others.

In autoimmune diseases, the immune system attacks itself and causes symptoms such as pain and swelling. As a TNF inhibitor, Enbrel affects the immune system by binding to TNF alpha and TNF beta, rendering TNF inactive. TNF is a substance in the body that causes inflammation.

Enbrel is available as a subcutaneous (under the skin) injection.

Drug Facts

Generic Name: Etanercept

Brand Name(s): Enbrel, Erelzi, Eticovo

Drug Availability: Prescription

Administration Route: Subcutaneous

Therapeutic Classification: Immunosuppressants

Available Generically: No

Controlled Substance: N/A

Active Ingredient: Etanercept

Dosage Form(s): Solution

What Is Enbrel Used For?

The Food and Drug Administration (FDA) approved Enbrel to treat:

How to Take Enbrel

Enbrel is administered by yourself or a caregiver via subcutaneous injection into the fatty layer of the abdomen, the outer area of the upper arm, or the front of the middle thigh. Before using Enbrel, be sure to read the medication guide provided to you with your prescription.

For the first injection, a healthcare provider will instruct you on how to administer Enbrel.

Storage

Enbrel vials and syringes should be stored in their original packaging to protect from light. They should be kept in the refrigerator at 36 degrees to 46 degrees Fahrenheit. Do not shake or freeze the medication. If needed, you can store Enbrel at room temperature (68 degrees to 77 degrees) for 14 days. However, do not put it back in the refrigerator once kept at room temperature.

The AutoTouch reusable autoinjector should be stored at room temperature.

Off-Label Uses

Healthcare providers may prescribe Enbrel for off-label uses, meaning for conditions not specifically indicated by the FDA.

Enbrel has been studied for the following off-label uses:

  • Juvenile spondyloarthropathy (a type of childhood arthritis of the lower back and sacroiliac joints) in children age 2 years and older
  • Graft-versus-host disease (a potentially serious complication of stem cell transplantation)
  • Sarcoidosis (a disease characterized by tiny collections of inflammatory cells affecting multiple organs of the body)

How Long Does Enbrel Take to Work?

In clinical trials, most people receiving Enbrel saw a clinical response within one to two weeks of starting the medication. The response nearly always occurred within three months. 

What Are the Side Effects of Enbrel?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

The most common side effects of Enbrel are:

  • Injection site reactions such as redness, itching, pain, swelling, bleeding, or bruising
  • Upper respiratory infections

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Infections: Enbrel can lower your body’s immune system’s ability to fight infections. In clinical trials, serious infections included pneumonia (lung infection), cellulitis (bacterial skin infection), septic arthritis (infection of the joint fluid), bronchitis (inflammation of the lining of the bronchial tubes), gastroenteritis (short-term inflammation of the digestive tract), pyelonephritis (a type of urinary tract infection), sepsis (an extreme response to an infection), abscess (accumulation of pus), tuberculosis (bacterial infection of the lungs), and osteomyelitis (infection in the bones).
  • Neurological events: TNF blockers, including Enbrel, have been associated with rare cases of new-onset or worsening central or peripheral nervous system demyelinating disorders (causing destruction of the protective myelin layer of nerves), and new or worsening seizure disorders. 
  • Congestive heart failure: Post-marketing reports have shown worsening or new-onset heart failure, sometimes without precipitating factors or in those without known heart disease, in Enbrel use.
  • Blood problems: Rare cases of pancytopenia (lower than normal blood cells and platelets), aplastic anemia (halted production of new blood cells), and neutropenia (having too few neutrophils, a type of white blood cell) have occurred in people treated with Enbrel. People taking Enbrel should be aware of signs and symptoms of blood abnormalities like persistent fever, bruising, bleeding, and pale appearance. Seek immediate medical attention if these occur. 
  • Cancers: Clinical trials of TNF blockers, including Enbrel, showed incidences of lymphoma (cancer of lymph system cells), leukemia (blood cancer), and skin cancer related to the use of these medications.

Long-Term Side Effects

There is a chance of developing autoantibodies with Enbrel. Rarely, treatment with Enbrel can result in a lupus-like syndrome or autoimmune hepatitis.

Dosage: How Much Enbrel Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage forms (prefilled autoinjector, prefilled cartridge, prefilled syringe, or vial):
    • For juvenile idiopathic arthritis:
      • Children 2 years of age and older weighing 63 kilograms (kg) or more—The dose is 50 milligrams (mg) injected under the skin once a week.
      • Children 2 years of age and older weighing less than 63 kg—Dose is based on body weight and must be determined by your doctor. The dose is 0.8 milligram (mg) per kilogram (kg) of body weight up to 50 mg, injected under the skin once a week.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • For plaque psoriasis:
      • Adults—At first, 50 milligrams (mg) injected under the skin 2 times per week, given 3 or 4 days apart, for 3 months. Then, your dose will be reduced to 50 mg once a week.
      • Children 4 years of age and older weighing 63 kilograms (kg) or more—The dose is 50 milligrams (mg) injected under the skin once a week.
      • Children 4 years of age and older weighing less than 63 kg—Dose is based on body weight and must be determined by your doctor. The dose is 0.8 milligram (mg) per kilogram (kg) of body weight up to 50 mg, injected under the skin once a week.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    • For rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis:
      • Adults—50 milligrams (mg) injected under the skin once a week.
      • Children—Use and dose must be determined by your doctor.

Modifications

There are no adequate studies of Enbrel in pregnancy. This drug should only be used in pregnancy if the benefits to the pregnant person outweigh the risks to the fetus. Studies in animals did not show fetal harm due to Enbrel. If you are pregnant while taking Enbrel, your healthcare provider may encourage you to register in a pregnancy registry to monitor outcomes.

Enbrel is excreted in breast milk in small quantities and is poorly absorbed by infants. However, there is no long-term follow-up data on infants who breastfed while the lactating person used Enbrel. Most experts and professional consensus guidelines view the use of Enbrel during breastfeeding as low risk to a nursing infant.

Clinical trials of Enbrel included a small number of people age 65 and older. This number is too small to determine whether people in this age group respond differently to Enbrel than younger individuals. Use Enbrel cautiously if you are older than 65, as you may be at a higher risk of infections in general.

Missed Dose

If you miss an injection of Enbrel, call your healthcare provider regarding when to take your next dose of Enbrel.

Overdose: What Happens If I Take Too Much Enbrel?

Overdose effects are expected to be similar to side effects experienced with normal doses. Treatment of an overdose is supportive. Monitor for signs and symptoms of infection. A healthcare provider may monitor your blood for decreased counts of cells important for fighting infections and preventing bleeding.

What Happens If I Overdose on Enbrel?

If you think you or someone else may have overdosed on Enbrel, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Enbrel, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Your body's ability to fight infection may be reduced while you are being treated with etanercept. It is very important that you call your doctor at the first signs of any infection. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.

While you are being treated with etanercept, do not have any immunizations (vaccines) without your doctor's approval. Your child's vaccines need to be current before he or she begins using etanercept. Be sure to ask your child's doctor if you have any questions about this.

This medicine may cause serious allergic reactions including anaphylaxis. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

You or your child will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

This medicine may increase your risk of having a lupus-like syndrome or autoimmune hepatitis. Check with your doctor right away if you or your child have a fever or chills, a general feeling of discomfort, illness, or weakness, light-colored stools, nausea, vomiting, upper right-sided abdominal or stomach pain, or yellow eyes and skin.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in your mouth or lips, or unusual tiredness or weakness.

Serious nervous system problems, including Guillain-Barré syndrome, multiple sclerosis, demyelinating disease, and seizures have occurred rarely in people using this medicine. Talk with your doctor if you have concerns about this.

A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer (eg, leukemia). Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you or your child have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

Check with your doctor right away if you have more than one of these symptoms: trouble breathing, swelling of the face, fingers, feet, or lower legs, or sudden weight gain. These may be signs of a heart condition called congestive heart failure (CHF).

Do not take other medicines unless they have been discussed with your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), or cyclophosphamide (Cytoxan®). Using any of them together with this medicine may increase your risk of having serious side effects.

What Are Reasons I Shouldn’t Take Enbrel?

You should not continue taking Enbrel if you develop a serious infection or sepsis.

What Other Medications Interact With Enbrel?

Some medications may interact with Enbrel if taken together, requiring closer monitoring or dosage adjustments.

These medications include:

  • The immune-modulating biologics Kineret (anakinra) and Orencia (abatacept): Using Enbrel with these medications can increase the incidence of infections.
  • Cytoxan (cyclophosphamide): Adding Enbrel to cyclophosphamide for Wegener's granulomatosis was associated with an increase in non-cutaneous solid cancers and did not improve clinical outcomes when compared with standard therapy alone.
  • Azulfidine (sulfasalazine): Taking Enbrel with sulfasalazine can decrease neutrophils (white blood cells important for fighting infections).

Additionally, do not receive any live vaccines while taking Enbrel. You may get other, non-live vaccines.

Live vaccines include immunizations for:

  • Mumps, measles, rubella (MMR)
  • Rotavirus
  • Chicken pox
  • Smallpox

What Medications Are Similar?

Other TNF blockers include:

These medications should be used together with Enbrel.

Frequently Asked Questions

  • What is Enbrel used for?

    Enbrel is used to treat moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis, in adults over 18 years of age. It is also used to treat moderate to severe juvenile idiopathic arthritis in children 2 years and older.

  • How does Enbrel work?

    Enbrel can help to reduce joint damage and symptoms of certain autoimmune diseases. People with these conditions have too much of the protein tumor necrosis factor (TNF), which is made by the immune system. Enbrel decreases the effects of TNF, thereby improving symptoms. However, Enbrel also suppresses the immune system, which can increase the risk of infections.

  • What are the side effects of Enbrel?

    The most common side effects of Enbrel are injection site reactions, upper respiratory infection, and headache. Rare but serious side effects include infections, including tuberculosis and hepatitis B infection in carriers, certain types of cancers, nervous system problems, blood problems, heart failure, allergic reactions, psoriasis, and autoimmune reactions.

How Can I Stay Healthy While Taking Enbrel?

Before starting treatment with Enbrel, be sure that you are up to date on all immunizations according to current immunization guidelines, since Enbrel may result in a less robust response to certain vaccines. Once you start Enbrel, you may continue to receive vaccines that are not live vaccines.

Your healthcare provider should test you for tuberculosis before starting treatment with Enbrel. If latent (dormant) TB is diagnosed, you should be treated with antibiotics. Monitor for signs and symptoms of TB and other infections while taking Enbrel. These signs and symptoms include:

  • Fever
  • Sweats or chills
  • Cough or flu-like symptoms
  • Shortness of breath
  • Muscle aches
  • Warm, red, or painful areas of skin
  • Sores on your body
  • Burning when urinating
  • Tiredness

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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