ST LOUIS (MD Consult) - On December 13, 2010, the US Food and Drug Administration (FDA) approved new labeling for Prezista (darunavir) to include once-daily dosing for treatment-experienced adults with no darunavir-resistance–associated substitutions. Before this approval, instructions for Prezista in this patient population called for twice-daily dosing. Prezista is approved for use in patients infected with human immunodeficiency virus (HIV).

The dosage for once-daily dosing with Prezista is 800 mg, and instructions specify that the drug be taken with ritonavir 100 mg once daily (with food). Other minor changes to Prezista's package insert were made for consistency. These include modifications to the Dosage and Administration, Adverse Reactions, and Clinical Studies sections of the insert.

圣路易斯(MD Consult)——2010年12月13日，美国食品药品管理局(FDA)批准了Prezista(达如那韦)的新说明书，其中包括将每天1次用药用于曾接受过治疗且未使用与达如那韦耐药有关的替代药的成人。在此批准令下达之前，Prezista在这类患者群体中的使用方法是每天2次用药。Prezista获准用于感染人类免疫缺陷病毒(HIV)的患者。

Prezista每天1次用药的剂量为800 mg，而使用说明中明确指出该药与利托那韦100 mg每天1次用药联用(餐时服用)。为了保持一致性，Prezista的包装插页也做了其他微小改动，其中包括对插页的剂量和用法、不良反应和临床研究部分的改变。