MRI造影剂Dotarem获得FDA批准

圣路易斯(MD Consult)——2013年3月20日和21日，美国食品药品管理局(FDA)和Guerbet宣布，Dotarem(钆特酸葡甲胺)——一种含钆造影剂(GBCA)——获准用于成人与儿科患者(年龄≥2岁)的脑部(颅内)、脊柱及相关组织磁共振成像(MRI)，以检测和显现血脑屏障受破坏和(或)异常血管分布区域。Dotarem 0.5 mmol/ml含有376.9 mg/ml钆特酸葡甲胺，可采用玻璃药瓶或预装药注射器盛装。

Dotarem的获准得到了2期和3期临床研究数据的支持。这两项研究评估了增强图像在中枢神经系统(CNS)病灶形象化方面相对于未增强图像的优势。受试者均在基线时接受了无Dotarem的MRI，继而接受使用Dotarem的MRI。这两项研究的结果均支持按照0.1 mmol/kg体重的标准剂量使用Dotarem。

在临床试验中，Dotarem的不良反应不多见。最常报告的不良反应包括恶心、头痛、注射部位痛或冷，以及烧灼感。包括Dotarem在内的所有GBCA的标签都带有一则关于肾源性系统性纤维化(NSF)的加框警告。目前尚无办法治疗NSF。所有获准的GBCA标签均介绍了尽可能降低NSF风险的途径。

Dotarem是FDA批准的第7种可用于CNS MRI的GBCA。

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ST LOUIS (MD Consult) - On March 20 and 21, 2013, the US Food and Drug Administration (FDA) and Guerbet announced the approval of Dotarem (gadoterate meglumine), a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine, and associated tissues in adult and pediatric patients (aged 2 years and older) to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity. Dotarem 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine, and is available in vials and prefilled syringes.

Data from 2 phase 3 clinical studies were used to support the FDA approval of Dotarem. Both studies evaluated the superiority of the enhanced images over the unenhanced images for central nervous system (CNS) lesion visualization. Each study participant underwent a baseline MRI without Dotarem, and then the MRI was repeated after Dotarem administration. Results from these trials support the use of Dotarem at a standard dose of of 0.1 mmol/kg of body weight.

Adverse effects to Dotarem were uncommon in clinical trials. However, the most commonly reported adverse effects were nausea, headache, pain or coldness at the injection site, and a burning sensation.

The labels for all GBCAs, including Dotarem, carry a Boxed Warning about the risk of nephrogenic systemic fibrosis (NSF). No known treatment for NSF exists, and all approved, professional GBCA labeling describes ways to minimize the NSF risk.

Dotarem is the seventh GBCA approved by the FDA for use in patients undergoing CNS MRI. 

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