In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA. Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. HUMIRA should not be used in patients with moderate or severe heart failure.
The most frequently reported adverse event (greater than or equal to 1/10 patients) at least possibly causally related to HUMIRA is injection site reaction (including pain, swelling, redness or pruritus). Other common adverse events (reported by 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, fatigue (including asthenia and malaise).
HUMIRA is the only fully human monoclonal antibody approved for the
treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque
psoriasis, ankylosing spondylitis (AS) and Crohn's disease in the United
States and Europe. 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. To date, HUMIRA has been
approved in 75 countries and more than 250,000 people worldwide
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