ST LOUIS (MD Consult) - On January 26, 2010, the US Food and Drug Administration (FDA) and Millenium: The Takeda Oncology Co issued an announcement about updates made to the prescribing information for Velcade (bortezomib). Velcade is indicated for the treatment of patients with multiple myeloma. It also is indicated for the treatment of patients with mantle-cell lymphoma who have already received at least 1 therapy.

The changes to the prescribing information include new safety information on dosing for patients with moderate to severe hepatic impairment. Bortezomib exposure is increased in these patients. Velcade should be started at a reduced dose of 0.7 mg/m² per injection during the first cycle, and a subsequent dose escalation to 1.0 mg/m² may be entertained. If patient tolerance becomes an issue, a dose reduction to 0.5 mg/m² may be considered. A dosing table is included in the updated product label to clarify the new recommendations.

圣路易斯(MD Consult)——2010年1月26日，美国食品药品管理局(FDA)与千禧:武田肿瘤药研发公司(Millenium: The Takeda Oncology Co)发布了关于更新万珂(硼替佐米)处方信息的通知。万珂除了适用于治疗多发性骨髓瘤患者之外，还适用于治疗已至少接受过1种疗法治疗的套细胞淋巴瘤患者。

 

对处方信息所作的变更包括新增针对中至重度肝损害患者的用药安全性信息，因该药在这些患者中的应用正逐渐增加。在首个治疗周期，万珂的初始剂量应为每次注射0.7 mg/m²，此后剂量可递增至1.0 mg/m²。如果患者无法耐受，则可考虑将剂量减至0.5 mg/m²。新产品标签中包含一个用量表，对新的用药建议进行了详细说明。