【警告和注意事项】
•免疫介导的肺炎：对于严重或危及生命的肺炎，中度和永久性停用。（5.1）
•免疫介导的结肠炎：当作为中度或重度的单一药物给予时，扣留OPDIVO，并且对于危及生命的结肠炎持续停止。 ipilimumab给予OPDIVO用于中度和永久性停用严重或危及生命的结肠炎。（5.2）
•免疫介导的肝炎：监测肝功能的变化。 对于严重或危及生命的转氨酶或总胆红素升高的中度和永久性停用。（5.3）
【INDICATIONS 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. (1.1)
• patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, as a single agent.(1.1)
• patients with unresectable or metastatic melanoma, in combination with ipilimumab.(1.1)
• patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting. (1.2)
• patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. (1.3)
• patients with metastatic small cell lung cancer with progression after platinumbased chemotherapy and at least one other line of therapy. (1.4)
• patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy. (1.5)
• patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma, in combination with ipilimumab. (1.5)
• adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: (1.6)
• autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or
• 3 or more lines of systemic therapy that includes autologous HSCT.
• patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. (1.7)
• patients with locally advanced or metastatic urothelial carcinoma who:
• have disease progression during or following platinum-containing chemotherapy
• have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. (1.8)
• adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab.(1.9)
• patients with hepatocellular carcinoma who have been previously treated with sorafenib. (1.10)
【DOSAGE AND ADMINISTRATION】
Administer OPDIVO as an intravenous infusion over 30 minutes.
• Unresectable or metastatic melanoma
• OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks.(2.1)
• OPDIVO 1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks. (2.1)
• Adjuvant treatment of melanoma
• OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)
• Metastatic non-small cell lung cancer
• OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks. (2.3)
• Small cell lung cancer
• OPDIVO 240 mg every 2 weeks. (2.4)
• Advanced renal cell carcinoma
• OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks.(2.5)
• OPDIVO 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks. (2.5)
【WARNINGS AND PRECAUTIONS】
• Immune-mediated pneumonitis: Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis. (5.1)
• Immune-mediated colitis: Withhold OPDIVO when given as a single agent for moderate or severe and permanently discontinue for life-threatening colitis. Withhold OPDIVO when given with ipilimumab for moderate and permanently discontinue for severe or life-threatening colitis. (5.2)
• Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation. (5.3)
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详细处方信息以本药内容附件PDF文件（201912720202333.pdf）的“原文Priscribing Information”为准
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