“In clinical trials, XELJANZ demonstrated consistent efficacy across a broad range of clinical measures and patient types, including patients who inadequately responded to non-biologic DMARDs and anti-TNF agents, and it has a safety profile that is well-characterized to date,” said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer. “We are proud of the comprehensive data that support the use of XELJANZ, and we are excited to make it available to patients in the U.S. as a powerful oral option that can be taken as a second-line treatment with or without methotrexate.”Safety findings observed in the overall XELJANZ RA program include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforations; decreased neutrophil and lymphocyte counts; decreased hemoglobin; liver enzyme elevations; and lipid elevations.
XELJANZ® Bottle Image
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