What is Enbrel?
Enbrel is a tumor necrosis factor (TNF) blocker used in the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and plaque psoriasis (PsO) in adults. Enbrel is also used to treat polyarticular juvenile idiopathic arthritis (JIA) patients aged two years or older. Enbrel works by blocking a protein called tumor necrosis factor (TNF). TNF is a protein produced by the body that causes inflammation. Enbrel blocks TNF production and reduces the amount of inflammation in the body. Enbrel can be used alone or with other medications.
Indications and Benefits of Enbrel
Enbrel (etanercept) is a tumor necrosis factor (TNF) inhibitor used to treat several inflammatory conditions, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and plaque psoriasis (PsO) in adults, and polyarticular juvenile idiopathic arthritis (JIA) in children aged two years or older.
- Rheumatoid arthritis: Enbrel is used in adults to reduce the signs and symptoms of moderately to severely active rheumatoid arthritis (RA).
- Psoriatic Arthritis: Enbrel is used in adults to reduce the signs and symptoms of patients with psoriatic arthritis.
- Ankylosing spondylitis: Enbrel is used in adults to reduce the signs and symptoms of patients with active ankylosing spondylitis.
- Plaque psoriasis: Enbrel is used in adults to reduce signs and symptoms of moderate to severe plaque psoriasis.
Polyarticular juvenile idiopathic arthritis (JIA): Enbrel is used in patients ages two and older to reduce the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis.
What Are the Benefits of Enbrel?
- Enbrel helps reduce pain, swelling, and stiffness in people with rheumatoid arthritis, making it easier to move and perform daily activities.
- It improves skin condition in people with psoriasis by reducing redness, itching, and scaly patches.
- It helps relieve back pain and stiffness in people with ankylosing spondylitis, a condition that affects the spine and joints.
- It reduces inflammation in people with Crohn’s disease, helping to control symptoms like abdominal pain and diarrhea.
- It helps manage ulcerative colitis by calming inflammation in the large intestine and improving bowel function.
- It blocks tumor necrosis factor, a substance in the body that causes inflammation and tissue damage in autoimmune conditions.
- It slows down joint damage, helping to protect bones and prevent disability in long-term conditions like rheumatoid arthritis.
- It helps improve physical strength and flexibility by lowering inflammation in joints and muscles.
- It provides long-term control of autoimmune symptoms, allowing patients to live more comfortably and actively.
- It works well with other treatments such as methotrexate or pain relievers, offering a more complete approach to managing chronic conditions.
- It reduces flare-ups of autoimmune diseases, helping patients maintain stable health over time.
Fact Table
| Fact Category | Fact Details |
| Generic Name | Etanercept |
| Medication Class | Tumor Necrosis Factor (TNF) inhibitor |
| Primary Use | Used to treat autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and juvenile idiopathic arthritis |
| Additional Benefit | Helps reduce inflammation, ease pain and swelling, slow joint damage, and improve physical function |
| Available Form | Pre-filled syringe and auto-injector pen |
| Method of Administration | Given as a subcutaneous injection under the skin |
| Frequency | Usually injected once weekly; dosage may vary based on the condition and patient response |
| Storage Instructions | Store in a refrigerator between 2°C and 8°C (36°F to 46°F); protect from light and do not freeze |
| Pregnancy and Breastfeeding | Considered Category B; use only under medical supervision during pregnancy or breastfeeding |
| Drug Interactions | May interact with live vaccines and other medications that weaken the immune system |
| Manufacturer | Amgen Inc. |
How It Works
Enbrel works by blocking a natural substance in the body called tumor necrosis factor, or TNF. TNF is a protein that causes inflammation, which can lead to pain, swelling, and damage to joints and skin.
In people with autoimmune conditions like rheumatoid arthritis or psoriasis, TNF levels are higher than normal.
Enbrel attaches to TNF and stops it from binding to its receptors on cells. This action helps reduce inflammation, ease joint pain, and improve skin symptoms.
By lowering TNF activity, Enbrel helps the body control its immune response and prevents further tissue damage.
Dosage
Enbrel is available in different forms and strengths, including a pre-filled syringe of 25 mg per 0.5 ml and 50 mg per ml, a single-dose SureClick autoinjector of 50 mg per ml, and a multiple-dose vial of 25 mg that needs to be mixed with a liquid before use.
The injection is given under the skin, and the dose depends on the condition and age of the patient.
What Dosage Strengths Does Enbrel Come In?
Enbrel is available in the following dosages and strengths
- Injection: 25 mg/0.5 mL and 50 mg/mL clear, colorless solution in a single-dose prefilled syringe
- Injection: 50 mg/mL clear, colorless solution in a single-dose prefilled SureClick autoinjector
- Injection: 25 mg/0.5 mL clear, colorless solution in a single-dose vial
- Injection: 50 mg/mL clear, colorless solution in Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector only
Dosage Chart
| Condition / Population | Recommended Dosage | Frequency | Notes |
| Adults with Rheumatoid Arthritis, Ankylosing Spondylitis, or Psoriatic Arthritis | 50 mg | Once weekly | Can be used with methotrexate, NSAIDs, or pain relievers. Higher doses do not increase effectiveness and may cause more side effects. |
| Adults with Plaque Psoriasis | Start with 50 mg twice weekly or 25–50 mg weekly | Once or twice weekly | The dose depends on the response. Some may start higher and reduce to once-weekly maintenance. |
| Children with Polyarticular Juvenile Idiopathic Arthritis (pJIA) | 0.8 mg per kg of body weight (up to 50 mg maximum) | Once weekly | Dose depends on child’s weight. Use reconstituted vial for more accurate dosing. |
| Children with Plaque Psoriasis or Juvenile Psoriatic Arthritis | 0.8 mg per kg of body weight (up to 50 mg maximum) | Once weekly | Children 63 kg or more: 50 mg weekly. Children under 63 kg: adjust by weight. |
| Older Adults (65 years and above) | Same as adult dose: 50 mg | Once weekly | Monitor closely for infections and side effects, as older adults may be more sensitive. |
| Patients with Kidney or Liver Impairment | No specific adjustment | Once weekly | Dose may remain the same, but medical supervision is important to monitor tolerance. |
| Combination Therapy (with Methotrexate) | 50 mg | Once weekly | Often used together for rheumatoid arthritis for better symptom control. |
| Forms and Strengths Available | Pre-filled syringe (25 mg/0.5 ml, 50 mg/ml); SureClick autoinjector (50 mg/ml); Multiple-dose vial (25 mg reconstituted) | – | All forms are given by subcutaneous injection. |
Usage Guide
Enbrel is given as a subcutaneous (under the skin) weekly injection. The injection is supplied in a prefilled injector pen, a prefilled syringe, and a single-dose vial.
How do you take Enbrel?
- Wash your hands thoroughly with soap and water before handling Enbrel. This helps prevent germs from entering the injection site.
- Check the Enbrel pen, syringe, or vial to make sure it is the correct dose and that it is not expired. Do not use it if the liquid looks cloudy or has particles.
- Allow the injection device to reach room temperature by leaving it out for about 15 to 30 minutes before use. Do not heat it in any other way.
- Choose an injection site on your body, such as the front of your thighs, the outer area of your upper arms, or your stomach, avoiding the area around your navel.
- Clean the chosen area with an alcohol swab and let it dry completely before injecting.
- Remove the needle cap carefully and hold the pen or syringe firmly in your hand.
- Insert the needle straight into your skin at a 90-degree angle if using a pen or as directed if using a syringe.
- Press the button on the pen or slowly push the plunger on the syringe to inject the dose.
- Keep the needle in place for a few seconds to make sure the full dose has been given, then remove it gently.
- Dispose of the used pen or syringe in a proper sharps disposal container and do not reuse it.
- Wash your hands again after completing the injection.
- Store the remaining Enbrel devices in the refrigerator and protect them from heat and light.
Side Effects
If you experience signs and symptoms of an allergic reaction, such as hives, rash, itching, difficulty breathing, or swelling of the face, mouth, or throat, seek medical attention immediately.
The most common side effects of Enbrel include:
- Upper respiratory infections (sinus infections)
- Skin reaction at the injection site, including redness, itching, pain, swelling, bleeding, and bruising
- Diarrhea
- Rash
- Itching
Some serious side effects can also occur. Seek immediate medical attention if you experience any of the following symptoms:
- Fever and chills
- Flu-like symptoms
- Pale skin
- Easy bleeding or bruising
- Night sweats
- Weight loss
- Stomach pain or bloating
- Swollen glands in the neck, armpits, or groin
- Cough
- Loss of appetite
- Tiredness
- Skin redness or scaly patches (new)
- Raised pus-filled bumps on the skin
- Dizziness
- Numbness or tingling
- Vision problems
- Weakness in the arms or legs
- Swelling of the lower extremities
- Joint pain or swelling
- Shortness of breath
- Chest pain/discomfort
- A skin rash on the cheeks or arms that worsens in sunlight
- Right-sided upper stomach pain
- Vomiting
- Yellowing of the skin or eyes
Missed Dose
If you miss a dose of Enbrel, take it as soon as you remember. If it is close to the time of your next dose, skip the dose and resume your injections at your next scheduled time. Do not take two doses at once.
Overdose
Taking too much Enbrel can lead to serious side effects. If you suspect an overdose, seek emergency medical attention or call the poison control helpline at 1-800-222-1222.
Storage Information
Enbrel should be stored in the refrigerator between 36°F to 46°F (2°C to 8°C). Enbrel can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days. Once removed from refrigeration, Enbrel should not be returned to the refrigerator.
Warnings & Precautions
Enbrel is contraindicated in those with a known allergy or sensitivity to Enbrel or its ingredients.
Children
Enbrel is approved for use in patients two years of age and older who have Polyarticular juvenile idiopathic arthritis (JIA).
Pregnancy
Enbrel is not recommended for use in pregnancy. The safety and efficacy have not been studied in these patients.
Lactation
Enbrel is not recommended for use in nursing mothers. The safety and efficacy have not been studied in these patients.
Serious Infections
Patients who take Enbrel have an increased risk of developing serious infections that may lead to hospitalization or death. Many different infections have been reported with TNF blockers, including bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens, including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis. Enbrel is not recommended in patients with an active infection, including localized infections. Patients 65 years and older may be at greater risk of infection. Before initiating therapy with Enbrel, the risks versus benefits of infection should be considered.
Special consideration should be given to:
- Patients with chronic or recurrent infections
- Patients who have been exposed to tuberculosis
- Patients with a history of opportunistic infections
- Patients who have traveled to endemic areas
- Patients with underlying conditions that increase the risk of infections, such as diabetes
Patients taking Enbrel require close monitoring for signs of infection. If serious infection or sepsis develops while taking Enbrel, it should be discontinued immediately. Patients who develop a new infection while receiving Enbrel should be closely monitored and treated.
Tuberculosis
Cases of new or reactivated tuberculosis infections have been observed in patients taking Enbrel. Patients who previously had tested negative for tuberculosis before initiating Enbrel have developed the disease. Testing for latent TB may be negative while receiving treatment with Enbrel. Tuberculosis should be strongly considered in patients who develop a new infection while receiving treatment with Enbrel, especially those who have previously or recently traveled to areas where TB is more prevalent.
Invasive Fungal Infections
There have been reports of serious and sometimes fatal fungal infections in patients taking TNF blockers. For patients who live in areas where mycoses are endemic, invasive fungal infections should be considered if patients develop a serious systemic illness.
Neurological Events
Patients who have taken TNF blocking agents have had a rare onset or exacerbation of central nervous system demyelinating disorders. Some patients have reported cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndrome, other peripheral demyelinating neuropathies, and new-onset or exacerbation of seizure disorders. Caution should be used in patients with pre-existing nervous system demyelinating disorders.
Cancers
Lymphoma: Reports of lymphoma have been associated with TNF blocking agents such as Enbrel. Research shows that even in the absence of TNF blocker treatment, patients with rheumatoid arthritis may be at higher risk of developing lymphoma.
Leukemia: Cases of acute and chronic leukemia have been reported in patients taking TNF blockers. Research shows that even in the absence of TNF blocker treatment, patients with rheumatoid arthritis may be at higher risk of developing leukemia.
Skin Cancers: Melanoma and non-melanoma skin cancer have been reported in patients who have been treated with TNF blockers. Periodic skin examinations should be performed for all patients taking Enbrel who may be at an increased risk of developing skin cancer.
Pediatric Cancers: Some cases of pediatric cancers have been reported in patients taking Enbrel. Most of the patients who developed cancers were receiving other immunosuppressants.
Heart Failure
Caution and careful monitoring should be used in patients with heart failure who are using Enbrel due to reports of worsening congestive heart failure symptoms in some patients.
Hematologic Events
Rare reports of blood disorders, including aplastic anemia, have been reported in some patients taking Enbrel. Caution should be used in patients with hematologic abnormalities. Patients should be educated on the signs and symptoms of blood disorders, including persistent fever, bruising, bleeding, and pallor, while on Enbrel. Enbrel should be discontinued in patients with significant hematologic abnormalities.
Hepatitis B Virus (HBV) Reactivation
Rare hepatitis B virus reactivation cases have been reported in some patients taking TNF blocking agents. Patients at risk for HBV infection should be evaluated before initiating treatment with Enbrel. Patients who are HBV carriers and require treatment with Enbrel should be closely monitored for signs of active infection. In patients who develop HBV reactivation, consider discontinuing Enbrel and starting antiviral treatment.
Live Vaccines
Live vaccinations should not be given concurrently with Enbrel. It is recommended that pediatric patients receive all live vaccines before starting Enbrel.
Autoimmunity
Patients taking Enbrel may develop a lupus-like syndrome or autoimmune hepatitis, which may resolve once Enbrel is discontinued. If patients develop symptoms of autoimmune disease, Enbrel should be discontinued.
Wegener’s Granulomatosis
The use of Enbrel in patients with Wegener’s granulomatosis who are also receiving immunosuppressive agents is not recommended.
Alcoholic Hepatitis
The use of Enbrel in patients with moderate to severe alcoholic hepatitis has shown an increased risk of mortality. Caution should be used in these patients.
Drug Interactions
This is not a complete list of potential drug interactions. Before taking Enbrel, tell your doctor if you take any medications, herbal supplements, or vitamins.
Anakinra
Anakinra (Kineret) is an interleukin-1 (IL-1) receptor antagonist used to treat rheumatoid arthritis. It works by blocking interleukin activity, which causes inflammation in the body.
Anakinra should not be taken with Enbrel due to an increased risk of serious infection, including bacterial pneumonia and cellulitis.
Abatacept
Abatacept is in a class of medications called selective costimulation modulators (immunomodulators). It works by blocking the activity of T-cells, a type of immune cell in the body that causes swelling and joint damage in people who have arthritis. Enbrel should not be taken with Abatacept due to an increased risk of serious adverse events, including infections.
Cyclophosphamide
Cyclophosphamide is a chemotherapy and immunosuppressive drug that is used to treat certain cancers. Enbrel should not be used concurrently with cyclophosphamide.
Sulfasalazine
Sulfasalazine belongs to a class of medications called anti-inflammatory drugs. It works to treat rheumatoid arthritis and polyarticular juvenile idiopathic arthritis by reducing inflammation within the body. Patients who have taken Enbrel and sulfasalazine have developed decreased neutrophil counts. Caution should be used.
Contraindications
Do not use Enbrel if you are allergic to etanercept or any of its ingredients, or if you have a serious infection such as sepsis.
Tell your doctor about your full medical history before starting treatment. This includes conditions like a weak immune system, HIV or AIDS, tuberculosis, or frequent infections.
You should also inform your doctor if you have heart failure, diabetes, asthma, epilepsy, hepatitis B, or nerve problems such as multiple sclerosis or optic neuritis.
Avoid using Enbrel if you have open wounds or skin sores, or if you are allergic to latex. People who have recently received certain vaccines or plan to be vaccinated should speak to their doctor first.
Using Enbrel may slightly increase the risk of some cancers, such as lymphoma, especially in young men taking other immune-suppressing treatments.
Women who are pregnant, planning pregnancy, or breastfeeding should consult their doctor, as Enbrel can pass into breast milk and may affect the baby.
Interactions
- Adalimumab
- Infliximab
- Certolizumab pegol
- Methotrexate
- Cyclosporine
- Azathioprine
- Anakinra
- Abatacept
- Rituximab
- Live vaccines
- Cytochrome P450 substrate drugs
- Sulfasalazine
- Warfarin
- Other anticoagulants
- Digoxin
- Cyclophosphamide
- Corticosteroids
- NSAIDs
- Insulin
- Oral diabetes medications
- Vitamins
- Calcium supplements
- Herbal products
Alternatives
- Otrexup (methotrexate)
- Arava (leflunomide)
- Orencia Clickject (abatacept)
- Cimzia (certolizumab)
- Actemra Actpen (tocilizumab)
- Rituxan (rituximab)
- Xeljanz (tofacitinib)
Frequently Asked Questions
Disclaimer
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