Infliximab

Infliximab was approved on October 13, 2006, for the reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and elimination of corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

CENTOCOR

Chimeric monoclonal antibody approved for the treatment of ulcerative colitis and maintenance of clinical remission

Infliximab was approved on October 13, 2006, for the reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and elimination of corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. This monoclonal antibody binds to tumor necrosis factor (TNF)-alpha, inhibiting its biological activity.

Safety. Patients treated with infliximab have an increased risk of serious infections, including bacterial sepsis, tuberculosis, and invasive fungal and other opportunistic infections, the progression of which could lead to hospitalization or death. Treatment of latent tuberculosis should be initiated before infliximab therapy, and infliximab should not be administered to patients with clinically important, active infections. The risk of serious infection is increased when infliximab is co-administered with etanercept and anakinra. Infliximab doses >5 mg/kg should not be administered to patients who have moderate-to-severe heart failure. Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis, have been reported rarely among patients receiving infliximab. Leukopenia, neutropenia, thrombocytopenia, and pancytopenia also have been reported in infliximab-treated patients; some cases have been fatal. Infusion-related reactions, including flu-like symptoms, headache, dyspnea, hypotension, transient fever, chills, gastrointestinal symptoms, and skin rashes, are common.

Dosing. The recommended dose of infliximab is 5 mg/kg at 0, 2, and 6 weeks for induction, followed by 5 mg/kg every 8 weeks for maintenance. Infusion should begin within 3 hours of solution preparation, and the solution must be administered over a period of ≥2 hours.