新型脂糖肽类抗生素Vibativ(telavancin 中文药名：盐酸特拉万星注射粉剂)获美国FDA批准用于治疗MRSA等严重的皮肤感染 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 VIBATIV is supplied in single-use vials containing either 250 mg or 750 mg of telavancin as a sterile, lyophilized powder. HABP/VABP VIBATIV is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable cSSSI VIBATIV is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: •Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) •Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or •Enterococcus faecalis (vancomycin-susceptible isolates only). Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative organisms. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. VIBATIV may be initiated as empiric therapy before results of these tests are known. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Important Safety Information Mortality Patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk. Nephrotoxicity New onset or worsening renal impairment occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed. Fetal Risk Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment. Contraindication Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration. VIBATIV is contraindicated in patients with a known hypersensitivity to the drug. Hypersensitivity Reactions Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin. Geriatric Use Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group. Infusion Related Reactions VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause "Red-man Syndrome" like reactions including: flushing of the upper body, urticaria, pruritus, or rash. QTc Prolongation Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV prolonged the QTc interval. Use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy. Most Common Adverse Reactions The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine https://www.vibativfacts.com/why-VIBATIV 制造商： 安斯泰来制药美国公司 药理分类： 抗生素（lipoglycopeptide） 活性成分（补）： 特拉万星（以HCl计）250毫克，750mg，每小瓶;密码重组和稀释后，为四输液不含防腐剂。 指示（补）： 复杂性皮肤和皮肤结构感染由于敏感克（+）菌。 药理： 特拉万星是一个万古霉素施加合成衍生物，通过抑制细菌细胞壁的合成及其抗菌作用，破坏细胞膜的功能。它已被证明是最有效的对金黄色葡萄球菌（包括甲氧西林株，耐药株，或MRSA）的，化脓性链球菌，无乳号，第anginosus组，粪肠球菌（vancomycin易感菌株只）。 在特拉万星的使用应避免病人谁怀孕，除非对病人的好处超过了潜在的风险对胎儿（如）骨骼畸形。 临床试验： 特拉万星（10mg/kg每天）对万古霉素比较两个随机，多国，双盲研究成人与临床记录复杂性皮肤和皮肤结构怀疑葡萄球菌感染或作为主要病原体确认（1克，每12小时）。病人可以得到伴随氨曲克怀疑或甲硝唑（ - ）或厌氧菌感染，分别为。在所有治疗功效（ATE）的人口，包括所有病人谁收到任何药物的研究，数额及对疗效进行评估;在临床上可评价（行政）有足够的人口，包括遵守协议那些在吃掉组患者。 吃掉的1794例，1410年进行临床评价疗效。每项试验的主要疗效终点是在在人口吃饭，行政长官访问后续临床治愈率。对于在审判1吃掉人口和审判2临床治愈率分别为72.5％和74.7％，分别为特拉万星，与71.6％和74.0％，对万古霉素。对于在这两次试验的行政长官的人口特拉万星临床治愈率分别为84.3％和83.9％，分别比82.8％和87.7％，对万古霉素。对MRSA的临床治愈率为特拉万星率为87.0％，而85.9％的万古霉素。 法律分类： 接收 成人： ≥18yrs：由四输注给超过60分钟。治疗7-14天。肾功能正常：10mg/kg每24小时。肾损害：肌酐清除率30-50mL/min：7.5mg/kg，每24小时;肌酐清除率10 - “30mL/min：10mg/kg每48小时;肌酐清除率”10mL/min或透析：不建议。 儿童： “18yrs：不推荐。 预防措施（补）： 前获取潜在妇女的生育待遇（-）妊娠试验;治疗过程中使用适当，有效的避孕方法。基线肌酐清除率≤50mL/min。监测肾功能。糖尿病。瑞士法郎。高血压。长QT综合征，无偿心脏衰竭，严重的左心室肥厚：不推荐。妊娠（Cat.C）：不建议，可能会对胎儿造成伤害。哺乳母亲。 互动（补）： 注意与其他药物可能导致QT间期延长。增加的风险与非甾体抗炎，ACE抑制剂，袢利尿剂肾毒性）。可能会干扰凝血试验（例如，葡萄牙/起始子，聘任，激活凝血时间，凝血的因子Xa测试）和一些尿蛋白测试。 不良反应（补）： 味觉障碍，小便混浊胃肠底价;肾毒性（重新评估，如果发生），输液反应（“红人综合征”），重叠（例如，抗生素相关性结肠炎），QT间期延长。 如何提供： 单用小瓶- 10 最后更新： 2010年1月21日 --------------------------------------------------- 注：以下产品不同规格和不同价格，采购请以咨询为准！ --------------------------------------------------- 产地国家: 美国 原产地英文商品名: VIBATIV POWDER 750mg/vial 10vials/box 原产地英文药品名: TELAVANCIN HCL 原产地英文化合物名称: N3”-[2-(decylamino)ethyl]-29-[[(phosphono-methyl)-amino]-methyl]- hydrochloride 中文参考商品译名: VIBATIV粉剂 750毫克/瓶 10瓶/盒 中文参考药品译名: 盐酸特拉万星 生产厂家中文参考译名: THERAVANCE INC 生产厂家英文名: THERAVANCE INC ----------------------------------------- 产地国家: 美国 原产地英文商品名: VIBATIV POWDER 250mg/vial 10vials/box 原产地英文药品名: TELAVANCIN HCL 原产地英文化合物名称: N3”-[2-(decylamino)ethyl]-29-[[(phosphono-methyl)-amino]-methyl]- hydrochloride 中文参考商品译名: VIBATIV粉剂 250毫克/瓶 10瓶/盒 中文参考药品译名: 盐酸特拉万星 生产厂家中文参考译名: THERAVANCE INC 生产厂家英文名: THERAVANCE INC ----------------------------------------- 产地国家: 德国 原产地英文商品名: VIBATIV POWDER 250mg/vial 10vials/box 原产地英文药品名: TELAVANCIN HCL 原产地英文化合物名称: N3”-[2-(decylamino)ethyl]-29-[[(phosphono-methyl)-amino]-methyl]- hydrochloride 中文参考商品译名: VIBATIV粉剂 250毫克/瓶 10瓶/盒 中文参考药品译名: 盐酸特拉万星 生产厂家中文参考译名: Clinigen Healthcare 生产厂家英文名: Clinigen Healthcare ----------------------------------------- 产地国家: 德国 原产地英文商品名: VIBATIV POWDER 750mg/vial 10vials/box 原产地英文药品名: TELAVANCIN HCL 原产地英文化合物名称: N3”-[2-(decylamino)ethyl]-29-[[(phosphono-methyl)-amino]-methyl]- hydrochloride 中文参考商品译名: VIBATIV粉剂 750毫克/瓶 10瓶/盒 中文参考药品译名: 盐酸特拉万星 生产厂家中文参考译名: Clinigen Healthcare 生产厂家英文名: Clinigen Healthcare ----------------------------------------- 产地国家: 英国 原产地英文商品名: VIBATIV POWDER 250mg/vial 10vials/box 原产地英文药品名: TELAVANCIN HCL 原产地英文化合物名称: N3”-[2-(decylamino)ethyl]-29-[[(phosphono-methyl)-amino]-methyl]- hydrochloride 中文参考商品译名: VIBATIV粉剂 250毫克/瓶 10瓶/盒 中文参考药品译名: 盐酸特拉万星 生产厂家中文参考译名: THERAVANCE 生产厂家英文名: THERAVANCE ----------------------------------------- 产地国家: 英国 原产地英文商品名: VIBATIV POWDER 750mg/vial 10vials/box 原产地英文药品名: TELAVANCIN HCL 原产地英文化合物名称: N3”-[2-(decylamino)ethyl]-29-[[(phosphono-methyl)-amino]-methyl]- hydrochloride 中文参考商品译名: VIBATIV粉剂 750毫克/瓶 10瓶/盒 中文参考药品译名: 盐酸特拉万星 生产厂家中文参考译名: THERAVANCE 生产厂家英文名: THERAVANCE