How it works:
Each of the diseases ENBREL is approved to treat affects the immune system - the body’s protection against invasion of infections and toxins. In these diseases, the immune system attacks the body’s own healthy cells, mistaking them for cells that don’t belong. This causes inflammation of the skin or in the lining or connective tissue of the joints.
Tumor necrosis factor (TNF) is one of the chemical messengers that helps regulate the inflammatory process. When the body produces too much TNF, it overwhelms the immune system’s ability to control inflammation of the joints or of psoriasis-affected skin areas. ENBREL is similar to a protein that the body produces naturally, and like this protein, it binds and deactivates some TNF molecules before they can trigger inflammation.
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ENBREL is a fully human anti-TNF receptor approved for use to reduce the signs and symptoms and inhibit the progression of structural damage in patients with moderately to severely active Rheumatoid Arthritis (RA). It is also approved to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis, moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older, ankylosing spondylitis, and chronic moderate to severe plaque psoriasis. ENBREL acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions that causes the inflammatory process.
Important Safety Information
WARNINGRISK OF SERIOUS INFECTIONS
Patients treated with ENBREL
® are at increased risk for developing serious infections that may lead to hospitalization or death (see
WARNINGS and
ADVERSE REACTIONS). 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.
The risks and benefits of treatment with ENBREL® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL
®, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
IMPORTANT SAFETY INFORMATION:
ENBREL HAS BEEN ASSOCIATED WITH SERIOUS AND SOMETIMES FATAL INFECTIONS, NEUROLOGIC EVENTS, HEMATOLOGIC EVENTS, MALIGNANCIES, AND HEPATITIS B REACTIVATION. CAUTION SHOULD BE USED WHEN GIVING ENBREL TO PATIENTS WITH MODERATE TO SEVERE ALCOHOLIC HEPATITIS. COMMON ADVERSE REACTIONS: HEADACHE, INFECTIONS AND INJECTION SITE REACTIONS.
