The potential role of ORENCIA in the development of malignancies in humans is unknown. A higher rate of lymphoma was seen compared to the general population however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). ![]() Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. Hypersensitivity: There were 2 cases (5% of patients who received ORENCIA in combination with a calcineurin inhibitor and methotrexate included pyrexia (20%), pneumonia (8%), acute kidney injury (7%), diarrhea (6%), hypoxia (5%), and nausea (5%). Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended. ![]() ![]() In controlled clinical trials, adult moderate to severe rheumatoid arthritis (RA) patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Increased Risk of Infection with Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended.
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