Enbrel (etanercept)

What is Enbrel used for?

Enbrel is used in the treatment of 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.

How is Enbrel Used?

Storage

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.

How to Take

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.

Dosage

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

 Dosing for Adults

Rheumatoid arthritis and psoriatic arthritis

• The recommended dosage of Enbrel in patients with rheumatoid arthritis and psoriatic is 50 mg once weekly

Ankylosing spondylitis

• The recommended dosage of Enbrel in patients with ankylosing spondylitis is 50 mg once weekly

Plaque Psoriasis

• The recommended dosage of Enbrel in patients with plaque psoriasis is 50mg twice weekly for three months, followed by 50mg once weekly.

Dosing for Children

Polyarticular Juvenile Idiopathic Arthritis (JIA)

• The recommended starting dose of Enbrel in children two years of age and older is 0.8mgkg weekly with a maximum dosage of 50 mg per week.

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.

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 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

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 placed in

• 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 that 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 syndromes, 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 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 have 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.

Alternative Medications

There are other drugs available to treat rheumatoid arthritis. It is important to note that this is not a complete list of alternative treatments; speak to your doctor to discuss other medications.

Methotrexate

Methotrexate belongs to a class of medications called antimetabolites. It works to treat psoriasis by slowing the growth of skin cells and stopping scales from forming. It also works to treat rheumatoid arthritis by decreasing the activity of the immune system.

Hydroxychloroquine (Plaquenil)

Hydroxychloroquine belongs to a class of medications called antimalarials. It works to treat rheumatoid arthritis by decreasing the activity of the immune system.

Sulfasalazine (Azulfidine)

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.

Leflunomide (Arava)

Leflunomide belongs to a class of medications called disease-modifying antirheumatic drugs (DMARDs). It is used to treat rheumatoid arthritis by decreasing inflammations and slowing disease progression. Other medications used to treat rheumatoid arthritis in this class include azathioprine (Imuran).

Tumor Necrosis Factor Inhibitors (TNF)

Enbrel is a tumor necrosis factor inhibitor. TNF inhibitors work by blocking TNF production, a protein produced by the body that causes inflammation. Other TNF blockers are available, including adalimumab (Humira) and infliximab (Remicade).

T-cell Costimulatory Blocking Agents

T-cell costimulatory blocking agents work by decreasing the activity of the immune system. They inhibit the activity of T lymphocytes and can be used in the treatment of rheumatoid arthritis. Medications in this class include abatacept (Orencia).

B-cell Depleting Agents

Rituximab (Rituxan) is a B-cell depleting agent that works by lowering the number of B-cells to reduce inflammation, pain, swelling, and joint damage in patients with rheumatoid arthritis.

Interleukin-1 (IL-1) Receptor Antagonist Therapy

Anakinra (Kineret) is an interleukin-1 (IL-1) receptor antagonist used to treat rheumatoid arthritis. It works by blocking the activity of interleukin, which causes inflammation in the body.

Immunomodulators (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.

Frequently Asked Questions