Transcription of OPDIVO U.S. Full Prescribing Information
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OPDIVO U.S. Full Prescribing Information
HIGHLIGHTS OF Prescribing INFORMATIONT hese highlights do not include all the Information needed to use OPDIVO safely and effectively. See full Prescribing Information for (nivolumab) injection, for intravenous use Initial Approval: 2014-----------------------------RECENT MAJOR CHANGES ----------------------------Indications and Usage (1) 8/2018 Dosage and Administration (2) 8/2018 Warnings and Precautions (5) 7/2018-----------------------------INDIC ATIONS AND USAGE ----------------------------- OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of: patients with BRAF V600 wild-type unresectable or metastatic melanoma, as a single agent.
• autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. Squamous Cell Carcinoma of the Head and Neck (SCCHN) • patients with recurrent or metastatic squamous cell carcinoma of the head and neck
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