Infliximab products neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit 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: the induction of pro-inflammatory 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.

AVSOLA 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.

AVSOLA is administered by intravenous infusion over a period of not less than 2 hours. •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 if they later lose their response. •Pediatric Crohn’s Disease: 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. •Ulcerative Colitis: 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. (2.3) •Pediatric Ulcerative Colitis: 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. 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.

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

• Serious infections – do not give AVSOLA during an active infection. If an infection develops, monitor carefully and stop AVSOLA if infection becomes serious. • Invasive fungal infections – for patients who develop a systemic illness on AVSOLA, 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.