FDA approves Enbrel to treat...( lar-course juvenile rheumatoid arthriti...),Health

lar-course juvenile rheumatoid arthritis (JRA) in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). It is also the first biologic approved to treat the signs and symptoms in patients with active ankylosing spondylitis (AS). ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

ENBREL has been used by more than 234,000 patients worldwide across indications.

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 of RA, JRA, psoriasis, psoriatic arthritis and AS. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.

Since the product was first introduced, the following have been reported in patients using ENBREL:

• Serious Infections
  • Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes
  • Some serious infections were fatal
  • Rare cases of tuberculosis

• What to do/Not to do
  • Do not start ENBREL if you have an infection or are allergic to ENBREL or its components.
  • Tell your doctor if you are prone to infection.
  • Stop ENBREL if a serious infection occurs.
  • Contact your doctor if you have questions about ENBREL or develop an infection.
  • Tell your doctor if you have ever been treated for heart failure.

• Serious nervous system disorders such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes
  • Tell your doctor if you have ever had any of these disorders or if you develop them after starting ENBREL.

• Rare reports of serious blood disorde
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2-May-2004


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