Infliximab products neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit the binding of TNFα with its receptors. Infliximab products do not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα. Biological activities attributed to TNFα include induction of proinflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes. See package insert for complete information.

INFLECTRA is a tumor necrosis factor (TNF) blocker indicated for: Crohn’s Disease : •reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. •reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. See package insert for complete information.

Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity) that occur during infusion and shortly after infusion INFLECTRA is administered by intravenous infusion for at least 2 hours with an in-line filter. Crohn’s Disease •5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg every 8 weeks if they later lose their response. See package insert for complete information.

Most common adverse reactions (>10%) – infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

• INFLECTRA doses >5 mg/kg in moderate or severe heart failure. •Previous severe hypersensitivity reaction to infliximab products or any inactive ingredients of INFLECTRA or to any murine proteins.

• Serious infections – do not give INFLECTRA during an active infection. If an infection develops, monitor carefully and stop INFLECTRA if the infection becomes serious. • Invasive fungal infections – for patients who develop a systemic illness on INFLECTRA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. • Malignancies – the incidence of malignancies, including invasive cervical cancer and lymphoma, was greater in infliximab-treated patients than in controls. Due to the risk of HSTCL carefully assess the risk/benefit especially if the patient has Crohn’s disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment. See package insert for complete information.