ST LOUIS (MD Consult) - On December 1, 2010, Cubist Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved its currently-marketed antibiotic, Cubicin (daptomycin), for once-a-day dosing as a 2-minute intravenous (IV) injection. The FDA originally approved Cubicin in 2003 as a once-daily 30-minute infusion.

Cubicin is approved as therapy for Staphylococcus aureus bacteremia, including right-sided endocarditis, caused by methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible S aureus, as well as complicated skin infections caused by certain gram-positive bacteria, including MRSA.

Most adverse events reported in clinical trials of Cubicin were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection-site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain effectiveness of the medication, Cubicin should be used only to treat or prevent infections that have been proved or are strongly suspected to be susceptible to the drug.

In addition to the approval of Cubicin as a 2-minute IV injection, several other changes to the Cubicin label have been incorporated. These include changes to the sections concerning warnings and precautions and postmarketing experience.

圣路易斯(MD Consult)——2010年12月1日，卡毕斯特制药公司(Cubist Pharmaceuticals)宣布，美国食品药品管理局(FDA)已批准其目前市售的抗生素库比星(Cubicin，达托霉素)2 min静脉注射剂每天1次用药。FDA最初于2003年批准了库比星30 min静脉注射剂每天1次用药。

库比星获准用作金黄色葡萄球菌性菌血症的治疗用药，包括耐甲氧西林金黄色葡萄球菌(MRSA)和甲氧西林敏感金黃色葡萄球菌引起的右心感染性心内膜炎以及由MRSA等某些革兰氏阳性菌引起的复杂性皮肤感染。

 

库比星临床试验报告的大多数不良事件是轻、中度紧张。最常见的不良反应是贫血、 便秘、腹泻、恶心、呕吐、注射部位的反应和头痛。为减少耐药菌的产生和维持该药的疗效，库比星应仅用于治疗或预防经确诊或极有可能对该药高度敏感的感染。

FDA在批准了库比星2 min静脉注射剂的同时，也批准了库比星说明书的其他多处变动，其中包括警告事项、注意事项和上市后经验部分的改变。