Remicade (Infliximab) Consent
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Remicade is currently approved for treatment of rheumatoid arthritis. Rheumatoid arthritis affects approximately 2.5 million Americans, mostly women.
In patients with rheumatoid arthritis, joint damage is caused by narrowing of the space between connecting bones, as well as erosions to bones.
“To reduce joint damage in patients with rheumatoid arthritis, a drug must have an effect on both joint space narrowing and bone erosions. Based on the clinical data, it appears that Remicade does both with compelling results,” said Harlan F. Weisman, M.D., senior vice president, research and development, Centocor. “Furthermore, the data suggest that treatment with Remicade improved a patient’s ability to do the everyday tasks that most of us take for granted.”
Risks or Possible Adverse Reactions: The most common side effects reported with the use of Remicade is upper respiratory tract infections such as the common cold, headache, nausea, sinusitis and rash. Some patients have experienced side effects at the time of infusion such as flu-like symptoms, headache, dizziness, muscle ache, low blood pressure, itching, flushing, sweating, rash, fever, sneezing, chest tightness, shortness of breath and stomach complaints like nausea and vomiting.
Patients with illness associated with the immune system, like rheumatoid arthritis, can develop infections more easily than healthy individuals and also have a higher than normal risk of developing cancers of the lymph glands. Patients treated with infliximab or Remicade have developed such problems ranging from skin infections, cold blisters, a common cold or urinary tract infection, to more severe infections such as pneumonia and bronchitis. TNF-alpha mediates inflammation and cellular immune response including response to infection. Serious infections, including sepsis and fatal infections, have been reported in patients receiving TNF-blocking agents. Many of the serious infections in patients treated with Remicade have occurred in patients on concomitant immunosuppressive therapy that, in addition to their Crohn’s disease or rheumatoid arthritis, could predispose them to infections. Patients treated with Remicade may have an increased risk of infection. Caution should be exercised when considering the use of Remicade in patients with chronic infection or a history of recurrent infection. Remicade should not be given to patients with a
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clinically important, active infection. Patients who develop a new infection while undergoing treatment with Remicade should be monitored closely. If a patient develops a serious infection or sepsis, Remicade therapy should be discontinued.
No LIVE vaccines while taking Remicade.
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I have read and fully understand all the benefits, risks and possible side effects of IV infusion of Remicade as an alternative treatment of my Rheumatoid Arthritis.
______I agree ______I do not agree to start this treatment.
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Patient Signature Date
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Witness Date