e reaction (including pain, swelling, redness or pruritus). Other common
adverse events (greater than or equal to 1/100 patients) at least possibly
causally related to HUMIRA include lower respiratory infections (including
pneumonia, bronchitis), viral infections (including influenza, herpes
infections), candidiasis, bacterial infection (including urinary tract
infections), upper respiratory infection, dizziness (including vertigo),
headache, neurologic sensation disorders (including paraesthesias), cough,
nasopharyngeal pain, diarrhea, abdominal pain, stomatitis and mouth
ulceration, nausea, hepatic enzymes increased, rash, pruritus,
musculoskeletal pain, pyrexia and fatigue (including asthenia and malaise).
About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved for the
treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA),
ankylosing spondylitis (AS), Crohn.s disease and plaque psoriasis (Ps) in
the United States and Europe. HUMIRA is also approved for the treatment of
juvenile idiopathic arthritis (JIA) in the United States, and review for
JIA in Europe is ongoing. Clinical trials are underway evaluating the
potential of HUMIRA in ulcerative colitis. To date, HUMIRA has been
approved in 75 countries and more than 250,000 people worldwide are
currently being treated with HUMIRA.
HUMIRA resembles antibodies normally found in the body. It works by
blocking tumor necrosis factor alpha (TNF-alpha), a protein that, when
produced in excess, plays a central role in the inflammatory responses of
many immune-mediated diseases.
In the United States, HUMIRA is approved by the FDA for reducing signs
and symptoms, inducing major clinical response, inhibiting the progression
of structural damage, and improving physical function in adult patients
with moderately to severely active rheumatoid arthritis (RA). HUMIRA can be
used alone or in combination with methotrexate (MTX) or other
disease-modifying anti-rheumatic drugs (
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