Indicated for:

Rheumatoid Arthritis (RA): (Adult)

• Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone.

Polyarticular Juvenile Idiopathic Arthritis: (Age 2 and older)

• Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.

Psoriatic Arthritis: (Adult)

• Reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Enbrel can be used with or without methotrexate.

Ankylosing Spondylitis: (Adult)

• Reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

Plaque Psoriasis: (Age 4 and older)

• Treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Enbrel is not effective for the treatment of patients with alcoholic hepatitis.

Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with Enbrel for Adult Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Patients.

In JIA patients, glucocorticoids, NSAIDs, or analgesics may be continued during treatment with Enbrel.

Enbrel should not be administered to patients with sepsis.

Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Enbrel should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include:

• Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Enbrel use and during therapy. Treatment for latent infection should be initiated prior to Enbrel use
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness
• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel.

Cases of acute and chronic leukemia have been reported in association with postmarketing TNF-blocker use in rheumatoid arthritis and other indications.

Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barre syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with Enbrel therapy.

Perform test for latent TB; if positive, start treatment for TB prior to starting Enbrel. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

Melanoma and non-melanoma skin cancer has been reported in patients treated with TNF antagonists including etanercept.

Rare (< 0.1%) reports of pancytopenia, including very rare (< 0.01%) reports of aplastic anemia, some with a fatal outcome, have been reported in patients treated with Enbrel.

In some instances, hepatitis B reactivation occurring in conjunction with TNF blocker therapy has been fatal. Prescribers should exercise caution in prescribing TNF blockers in patients previously infected with HBV.

There have been postmarketing reports of worsening of congestive heart failure (CHF), with and without identifiable precipitating factors, in patients taking Enbrel. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known preexisting cardiovascular disease. Some of these patients have been under 50 years of age.

Physicians should use caution when using Enbrel in patients with moderate to severe alcoholic hepatitis.

There have been reports of hypoglycemia following initiation of Enbrel therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.

The use of Enbrel in patients with Wegener’s granulomatosis receiving immunosuppressive agents is not recommended.

The use of Enbrel in patients with granulomatosis with polyangiitis receiving immunosuppressive agents is not recommended. In a study of patients with granulomatosis with polyangiitis, the addition of Enbrel to standard therapy (including cyclophosphamide) was associated with a higher incidence of non-cutaneous solid malignancies and was not associated with improved clinical outcomes when compared with standard therapy alone.

Patients in a clinical study who were on established therapy with sulfasalazine, to which Enbrel was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either Enbrel or sulfasalazine alone.

Treatment with Enbrel should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with comorbid conditions, and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection.

• The risks and benefits of treatment should be considered prior to initiating therapy in patients:
• With chronic or recurrent infection
• Who have been exposed to tuberculosis
• With a history of an opportunistic infection
• Who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis coccidioidomycosis, or blastomycosis or
• With underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes

Use of Enbrel with cyclophosphamide is not recommended.

Use of Enbrel with anakinra or abatacept is not recommended.

Live vaccines should not be given concurrently with Enbrel.

Studies showed the proportion of liveborn infants with major birth defects was higher for women exposed to etanercept compared to diseased etanercept unexposed women. The risk of fetal/neonatal adverse reactions with in utero exposure to Enbrel is unknown. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to Enbrel in utero.

Limited data from published literature show that etanercept is present in low levels in human milk and minimally absorbed by a breastfed infant. No data are available on the effects of etanercept on the breastfed child or the effects on milk production.

GoToSource

• Use in patients under the age of 2 for JIA. GoToSource

• Use in patients under the age of 4 for PsO. GoToSource

• Behçet’s disease, sarcoidosis and noninfectious uveitis. GoToSource

• Ocular inflammation. GoToSource

• Persistent oligoarticular juvenile idiopathic arthritis. GoToSource

• Retard renal function decline in patients with type 1 diabetes and nephropathy. GoToSource

• Vitiligo. GoToSource

• Alzheimer’s disease and chronic neurological dysfunction following stroke. GoToSource

• Inflammatory bowel disease, pyoderma gangrenosum and hidradenitis suppurativa. GoToSource

• Reduction or prevention of hypertrophic scars, keloid scars and recurrence of post-excision keloid lesions. GoToSource

• Sjögren syndrome, wegener granulomatosis, systemic lupus erythematosus, adult-onset still disease, cryoglobulinemia and polymyositis. GoToSource

• Recurrent aphthous stomatitis, benign mucous membrane pemphigoid and lichen planus. GoToSource

• Alopecia areata, steroid-resistant or steroid-dependent acute graft-versus-host disease, scleroderma, nail psoriasis, and palmoplantar psoriasis. GoToSource

• Multicentric reticulohistiocytosis, sneddon-wilkinson disease, SAPHO syndrome, pityriasis rubra pilaris, eosinophilic fasciitis, panniculitis, crohn’s disease and necrobiosis lipoidica diabeticorum. GoToSource

• Autoimmune inner ear disease. GoToSource

• Recurrent aphthous ulcers. GoToSource

• Chronic back and/or neck disc-related pain. GoToSource

• Vasculitis and large-vessel vasculitides giant cell arteritis. GoToSource

• Papa syndrome. GoToSource

• Pemphigus vulgaris. GoToSource

• Amyloid A amyloidosis. GoToSource

• Churg-strauss syndrome. GoToSource

• Cicatricial pemphigoid. GoToSource

• Dermatomyositis. GoToSource

• Erythrodermal psoriasis. GoToSource

• Langerhans’-cell histiocytosis. GoToSource

• Reiter’s syndrome. GoToSource

Increased risk of serious virus (herpes simplex) and bacterial (listeria monocytogenes) neuroinfections, progressive multifocal leukoencephalopathy and herpes simplex encephalitis. GoToSource

Multiple brain abscess formation. GoToSource

New onset or exacerbation of pre-existing multiple sclerosis, optic neuritis and seizures. GoToSource

Pancytopenia (decrease in all three blood cell types) and aplastic anemia. GoToSource

Intestinal perforation. GoToSource

Postoperative eyelid infections. GoToSource

Encephalopathy (brain disease or disorder). GoToSource

Tuberculosis infection. GoToSource

Neutropenia (low white blood cells). GoToSource

Pulmonary sarcoidosis (inflamed tissues in the lungs). GoToSource

Increased risk of development of lymphoma and other cancers in children and young adults. GoToSource

Worsening and new onset of congestive heart failure. GoToSource

Lawsuits filed for tuberculosis, lymphomas in children and young adults, fungal infections including histoplasmosis, blastomycosis and coccidioidomycosis.