11/26/03 Adverse reactions to infliximabSummaryInfliximab (Flix) trade name Remicade, is a chimeric monoclonal antibody against tumor necrosis factor alpha. Flix is being tried in the treatment of a variety of disorders, particularly severe rheumatoid arthritis and inflammatory bowel disease. In early clinical trials of Flix, a very low incidence of adverse reactions were observed. Cheifetz et al of the Mt. Sinai Medical Center in New York described the incidence of allergic type adverse reactions in 165 consecutive patients who received 479 Flix infusions over a period of 30 months. They observed an overall incidence of adverse reactions during 6.1% of the infusions of which about 5% were acute and 1% were severe. Serum tryptase levels were not increased. All acute reactions were controlled with appropriate therapy depending on manifestations : 1) slow infusion rate to 10ml/hour; 2) dephenhydramine, acetaminophen; 3) epinephrine prn chest tightening; 4) solu-steroids if significant dyspnea/wheezing; 5) stop infusion if severe urticaria or systolic BP decreases ä 40mm. Maintain airway and oxygenation. Individuals with previous mild-moderate adverse reactions to Flix were re-treated with Flix using a prophylactic regimen: 1) pre-treatment with diphenhydramine 25-50 mg po and acetaminophen (650 mg po) 1.5 hours prior to infusion; 2) test infusion of Flix at slow rate (4 drops/minute) for 15 minutes; 3) if Flix tolerated, increase infusion rate gradually every 15 minutes as tolerated until 40 drops/minute. All such treated patients tolerated the repeat Flix infusions without adverse reactions. In 3 patients with severe reactions to Flix, repeat Flix infusions were tried using the prophylactic regimen described above. Two tolerated this Flix treatment with no problems; a repeat severe reaction occurred in the third patient. Reference Am J Gastroent 2003;98:1315-24
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