ST LOUIS (MD Consult) - On May 27, 2010, the US Food and Drug Administration announced the approval of changes made to the labeling for Selzentry (maraviroc), a drug used in the treatment of infection with human immunodeficiency virus (HIV). These changes reference use of the product in patients with renal impairment.

Changes were made to the labeling for Selzentry 150-mg and 300-mg tablets to expand the patient population to include patients with renal impairment, using renal function and types of concomitant medications as guiding factors in the decision and dosing. A contraindication for use of the product in patients with severe renal impairment or end-stage renal disease was added. Furthermore, a warning regarding postural hypotension occurring in patients with renal impairment now appears on the label.

The Selzentry medication guide for patients was also modified. The guide contains information about the use of Selzentry in the setting of kidney problems.

 

圣路易斯(MD Consult)——2010年5月27日，美国食品药品管理局(FDA)宣布批准Selzentry (马拉维若)产品标签的更改，这是一种用于人免疫缺陷病毒(HIV)感染的治疗药物。更改内容涉及肾损害患者的用药须知。

 

这次是对Selzentry 150mg和300mg片剂的产品标签进行了更改，将适用人群扩大至肾损害患者，在制定治疗决策和确定用药剂量时将患者的肾功能以及伴随用药的类型作为指导因素。同时还补充了一条禁忌证，该产品禁用于重度肾损害或终末期肾病患者。此外，更新后的标签还增加了一条警示信息，提醒肾损害患者用药后可能出现体位性低血压。

 

针对患者的Selzentry用药指南也作了调整。指南中包含了出现肾脏问题时Selzentry的用药须知。