How Supplied:
20 mL, 10 viles
Indications and Usage:
Remicade is indicated for the treatment of: 1) Adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate; 2) in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; 3) for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; 4) reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; 5) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease; 6) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; 7) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; and 8) reducing signs and symptoms in patients with active ankylosing spondylitis.
Prescribing Instructions:
Prescribing Information Instructions [PDF]
Side Effects and Contraindications:
Side effects may include respiratory infections such as sinus infections and sore throat, headache, rash, coughing, and stomach pain. Serious and sometimes fatal side effects include serious infections, reactivation of tuberculosis, nervous system or demyelinating disorders, congestive heart failure, increased incidence of cancer, liver injury, blood disorders, immediate or delayed type allergic reactions, or a lupus-like syndrome. The FDA concluded that tumor necrosis factor (TNF) blockers increase risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers.
Company:
Janssen Pharmaceuticals, Inc.
800-457-6399
remicade.com
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