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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. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. ( 1.1 ) Pediatric Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.2 ) Ulcerative Colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.3 ) Pediatric Ulcerative Colitis: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.4 ) Rheumatoid Arthritis in combination with methotrexate: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease. ( 1.5 ) Ankylosing …

The use of RENFLEXIS at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ] . RENFLEXIS is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab products or any of the inactive ingredients of RENFLEXIS or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] [see Warnings and Precautions (5.7) and Adverse Reactions (6.1) ] . RENFLEXIS doses >5 mg/kg in moderate or severe heart failure. ( 4 ) Previous severe hypersensitivity reaction to infliximab products or any inactive ingredients of RENFLEXIS or to any murine proteins. ( 4 )

Serious infections – do not give RENFLEXIS during an active infection. If an infection develops, monitor carefully and stop RENFLEXIS if infection becomes serious. ( 5.1 ) Invasive fungal infections – for patients who develop a systemic illness on RENFLEXIS, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. ( 5.1 ) 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. ( 5.2 ) Hepatitis B virus reactivation – test for HBV infection before starting RENFLEXIS. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop RENFLEXIS and begin anti-viral therapy. ( 5.3 ) Hepatotoxicity – severe hepatic reactions, some fatal or necessitating liver transplantation. Stop RENFLEXIS in cases of jaundice and/or marked liver enzyme elevations. ( 5.4 ) Heart failure – new onset or worsening symptoms may occur. ( 4 , 5.5 ) Cytopenias – advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping RENFLEXIS. ( 5.6 ) Hypersensitivity – serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur. ( 5.7 ) Cardiovascular and Cerebrovascular …

8.1 Pregnancy Risk Summary Available observational studies in pregnant women exposed to infliximab products showed no increased risk of major malformations among live births as compared to those exposed to non-biologics. However, findings on other birth and maternal outcomes were not consistent across studies of different study design and conduct [see Data ] . Monoclonal antibodies such as infliximab products are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant [see Clinical Considerations ] . Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal …