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详细处方信息以本药内容附件PDF文件（201941420093537.pdf）的“原文Priscribing Information”为准
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部分中文POMALYST处方资料（仅供参考）

【英文名称】POMALYST

【适用证】

POMALYST是一种沙利度胺类似物，与地塞米松联合用于多发性骨髓瘤患者，这些患者至少接受过两种治疗，包括来那度胺和蛋白酶体抑制剂，并且在最后一次治疗完成后60天内或之后显示疾病进展（1.1）。

【用法用量】

多发性骨髓瘤：每天4mg，在重复的28天周期的第1-21天口服，直至疾病进展（2.1）。 地塞米松给药参见14.1节（14.1）

【禁忌】

怀孕

【警告和注意事项】

死亡率增加：当pembrolizumab加入地塞米松和沙利度胺类似物时，观察到多发性骨髓瘤患者（5.4）。

血液学毒性：中性粒细胞减少症是最常报告的3/4级不良事件。 监测患者的血液学毒性，尤其是中性粒细胞减少症（5.5）。

肝毒性：肝功能衰竭，包括死亡; 每月监测肝功能检查（5.6）。

包括过敏反应的严重皮肤反应：已报道血管性水肿和严重的皮肤反应，包括Stevens-Johnson综合征，中毒性表皮坏死松解症，嗜酸性粒细胞增多的药物反应和全身症状。 停止POMALYST治疗血管性水肿和严重反应（5.7）。

肿瘤裂解综合症（TLS）：监测有TLS风险的患者（即肿瘤负荷高的患者）并采取适当的预防措施（5.11）

【INDICATIONS AND USAGE】

POMALYST is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).

【DOSAGE AND ADMINISTRATION】

Multiple Myeloma: 4 mg per day taken orally on Days 1-21 of repeated 28- day cycles until disease progression (2.1). Refer to section 14.1 for dexamethasone dosing (14.1)

【WARNINGS AND PRECAUTIONS】

 Increased Mortality: Observed in patients with multiple myeloma when pembrolizumab was added to dexamethasone and a thalidomide analogue (5.4).

 Hematologic Toxicity: Neutropenia was the most frequently reported Grade 3/4 adverse event. Monitor patients for hematologic toxicities, especially neutropenia (5.5).

 Hepatotoxicity: Hepatic failure including fatalities; monitor liver function tests monthly (5.6).

 Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms have been reported. Discontinue POMALYST for angioedema and severe reactions (5.7).

 Tumor Lysis Syndrome (TLS): Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions (5.11)

【CONTRAINDICATIONS】  Pregnancy

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详细处方信息以本药内容附件PDF文件（201941420093537.pdf）的“原文Priscribing Information”为准
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