2013年6月21日美国食品药品监督管理局(FDA)扩展抗生素Vibativ(特拉万星telavancin)的批准使用治疗有医院获得金黄色葡萄球菌和所致呼吸机相关细菌性肺炎(HABP/VABP)患者。Vibativ只应当另外治疗不适宜时使用治疗HABP/VABP。
细菌性肺炎是一种肺感染可能被许多不同类型细菌所致。Vibativ只被批准治疗金黄色葡萄球菌，而不是其他致肺炎细菌。HABP/VABP，也被称为园内获得性肺炎，是一种特别严重感染，因为患者在医院内和尤其他们用呼吸机往往早已病得很重和通常不能与感染斗争。
美国FDA药物评价和研究中心抗微生物产品室主任Edward Cox, M.D., M.P.H 说：“今天的批准证实FDA的承诺治疗严重疾病像HABP/VABP，尤其是对病得非常重已经耗竭或不能再使用其他可利用治疗的患者得到新的治疗选择。”
在1,532例被纳入两项临床试验患者中评价Vibativ治疗HABP/VABP的安全性和有效性。患者被随机赋予接受Vibativ或万古霉素[vancomycin]，另一个被FDA批准的抗生素。
在治疗开始后28天试验测量死于任何原因患者的百分率(所有原因死亡率)。在基线时Among 患者对金黄色葡萄球菌假定测试阳性， Vibativ和万古霉素治疗组死亡率有可比性, 除了预先有肾问题患者。
在临床试验期间，预先存在肾问题患者用Vibativ治疗与万古霉素治疗患者比较死亡更多。在患者中Vibativ还可能致新或变坏肾问题。这个资料已经加入至 Vibativ的黑框警告。
在临床中腹泻是被确定的最常见副作用。
在2009年Vibativ 被批准治疗复杂性皮肤和皮肤结构感染。药品由总部在加州旧金山的Theravance, Inc.上市。
Manufacturer:
Astellas Pharma US, Inc.
Pharmacological Class:
Antibiotic (lipoglycopeptide)
Active Ingredient(s):
Telavancin (as HCl) 250mg, 750mg; per vial; pwd for IV infusion after reconstitution and dilution; preservative-free.
Indication(s):
Complicated skin and skin structure infections due to susceptible gram (+) bacteria.
Pharmacology:
Telavancin is a synthetic derivative of vancomycin that exerts its antibacterial effect by inhibiting bacterial cell wall synthesis and disrupting the functioning of the cell membrane. It has been shown to be effective against most isolates of Staphylococcus aureus (including methicillin-resistant strains, or MRSA), Streptococcus pyogenes, S. agalactiae, S. anginosus group, E. faecalis (vancomycin-susceptible strains only).
The use of telavancin should be avoided in patients who are pregnant, unless the benefits to the patient outweighs the potential risks to the fetus (eg, skeletal malformations).
Clinical Trials:
Telavancin (10mg/kg daily) was compared to vancomycin (1g every 12 hrs) in two randomized, multinational, double-blind studies in adults with clinically documented complicated skin and skin structure infections with MRSA suspected or confirmed as the primary pathogen. Patients could receive concomitant aztreonam or metronidazole for suspected gram (–) or anaerobic infections, respectively. The all-treated efficacy (ATe) population included all patients who received any amount of study drug and were evaluated for efficacy; the clinically evaluable (CE) population included those patients in the ATe group with sufficient adherence to protocol.
Of 1794 ATe patients, 1410 were clinically evaluable. The primary efficacy endpoint for each trial was the clinical cure rate at a followup visit in the ATe and CE populations. The clinical cure rates for the ATe populations in Trial 1 and Trial 2 were 72.5% and 74.7%, respectively, for telavancin, compared with 71.6% and 74.0% for vancomycin. The clinical cure rates for telavancin in the CE populations for the two trials were 84.3% and 83.9%, respectively, compared with 82.8% and 87.7% for vancomycin. The clinical cure rate for MRSA for telavancin was 87.0% compared to 85.9% for vancomycin.
Legal Classification:
Rx
Adults:
≥18yrs: Give by IV infusion over 60 minutes. Treat for 7–14 days. Normal renal function: 10mg/kg every 24hrs. Renal impairment: CrCl 30–50mL/min: 7.5mg/kg every 24 hrs; CrCl 10 – <30mL/min: 10mg/kg every 48hrs; CrCl<10mL/min or dialysis: not recommended.
Children:
<18yrs: not recommended.
Precaution(s):
Obtain (–) pregnancy test before treatment for women of childbearing potential; use appropriate effective contraception during treatment. Baseline CrCl≤50mL/min. Monitor renal function. Diabetes. CHF. Hypertension. Long QT syndrome, uncompensated heart failure, severe left ventricular hypertrophy: not recommended. Pregnancy (Cat.C): not recommended, may cause fetal harm. Nursing mothers.
Interaction(s):
Caution with other drugs that can cause QT prolongation. Increased risk of renal toxicity with NSAIDs, ACE inhibitors, loop diuretics). May interfere with coagulation tests (eg, PT/INR, aPPT, activated clotting time, coagulation-based factor Xa tests) and some urine protein tests.
Adverse Reaction(s):
Dysgeusia, GI upset, foamy urine; nephrotoxicity (reevaluate if occurs), infusion reactions ("red man syndrome"), superinfection (eg, antibiotic-associated colitis), QT prolongation.
How Supplied:
Single-use vials—10
Last Updated:
1/21/2010