新的抗菌药物Dalvance（dalbavancin，达巴万星）上市，用于治疗包括金黄色葡萄球菌和化脓性链球菌等细菌引起的急性细菌性皮肤和皮肤结构感染（ABSSSI）。 2014年5月23日,美国食品药品监督管理局(FDA)批准Dalvance(dalbavancin)，一种新抗细菌药用于治疗成年皮肤感染。 Dalvance被意向治疗由某些易感细菌像金黄色葡萄球菌[Staphylococcus aureus](包括甲氧西林敏感和甲氧西林耐药株)和化脓性链球菌[Streptococcus pyogenes]急性细菌性皮肤和皮肤结构感染(ABSSSI)。治疗是静脉给药。 Dalvance是第一个接受FDA批准作为合格的传染病产品[Qualified Infectious Disease Product (QIDP)]设计的药物。在安全和创新法案的抗生素激励计划(GAIN)项目下，Dalvance被授权QIDP指定因为它是一个抗细菌或抗真菌人用药物意向治疗严重或危及生命感染。 FDA的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鼓励增加发展和批准新抗细菌药物的承诺，提供医生和患者重要新治疗选择”。 作为其QIDP指定的部分，Dalvance被给予优先审评，它提供药物申请的加快审评。Dalvance的QIDP指定还具有资格获得另外五年市场独占权被添加至早已被食品，药品和化妆品法案提供时间。 在两项临床试验总共1,289例有ABSSSI成年中评价Dalvance的安全性和疗效。参加者被随机地赋予接受Dalvance或万古霉素[vancomycin]，另一个抗细菌药。结果显示对ABSSSI的治疗Dalvance与万古霉素一样有效。 在临床试验中被确定的最常见副作用是恶心，头痛和腹泻。在试验中，Dalvance组有更多参加者其肝酶检验之一有升高。Dalvance药物使用说明书对有肾受损患者提供剂量调整的建议。 Dalvance由总部在芝加哥Durata Therapeutics上市，由Haoeyou Pharmacy负责销售。 批准日期：2014年5月23日；公司：Durata Therapeutics，Inc. 注射用DALVANCE(达巴万星,dalbavancin)，为静脉使用 美国初次批准：2014 适应证和用途 DALVANCE是适用为革兰氏阳性微生物指定的敏感株所致的急性细菌性皮肤和皮肤结构感染(ABSSSI). 减低耐药性细菌的发生和维持DALVANCE和其他抗细菌药物的有效性，DALVANCE只应用于治疗感染被证明或强烈怀疑是有易感细菌所致。 剂量和给药方法 ⑴ 2剂方案：1000mg接着一周后500mg。 ⑵对有肌酐清除率小于30 mL/min和不接受常规时间表血液透析患者调整剂量: 750mg接着一周后375mg ⑶通过静脉输注历时30分钟给药 剂型和规格 注射用：为重建在一个单次-使用小瓶500mg 冻干粉 DALVANCE(dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections(ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group(including S. anginosus, S. intermedius, S. constellatus).  Important Safety Information Contraindications DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin. Warnings and Precautions Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE; exercise caution in patients with known hypersensitivity to glycopeptides. Rapid intravenous infusion of glycopeptide antibacterial agents can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash. ALT elevations with DALVANCE treatment were reported in clinical trials. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE. Evaluate if diarrhea occurs. Adverse Reactions The most common adverse reactions in patients treated with DALVANCE were nausea (5.5%), headache (4.7%), and diarrhea (4.4%). Use In Specific Populations In patients with renal impairment whose known creatinine clearance is less than 30mL/min and who are not receiving regularly scheduled hemodialysis, the recommended two-dose regimen for DALVANCE is 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis. DALVANCE(dalbavancin)for injection,for intravenous use DALVANCE Rx Pharmacological Class: Lipoglycopeptide. Active Ingredient(s): Dalbavancin 500mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free. Company Durata Therapeutics Indication(s): Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible Gram (+) organisms: Staphylococcus aureus (including MRSA and MSSA), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus). Pharmacology: Dalbavancin is a semisynthetic lipoglycopeptide that interferes with cell wall synthesis by binding to the D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, thus preventing cross-linking. Dalbavancin is bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes at concentrations similar to those sustained throughout treatment in humans treated according to the recommended dosage regimen. Clinical Trials: Adult patients with acute bacterial skin and skin structure infections (ABSSSI) were enrolled in two Phase 3, randomized, double-blind, double-dummy clinical trials of similar design (Trials 1 and 2). The intent-to-treat (ITT) population involved 1,312 randomized patients. Patients were in treatment for two weeks and were given either a 2-dose regimen of IV Dalvance (1000mg followed by 500mg one week later) or IV vancomycin (1000mg or 15mg/kg every 12 hours, with an option to switch to oral linezolid after 3 days). The primary endpoint of Trials 1 and 2 was the clinical response rate where responders were defined as patients who had no increase from baseline in lesion area 48–72 hours after initiation of therapy, and had a temperature consistently ≤37.6°C upon repeated measurement. In Trial 1, 83.3% of the Dalvance treatment group met the primary endpoint as compared to 81.8% of the Vancomycin/Linezolid treatment group (treatment difference 1.5% [95% CI: 4.6, 7.9]). In Trial 2, 76.8% of the Dalvance treatment group met the primary endpoint as compared to 78.3% of the Vancomycin/Linezolid treatment group (treatment difference 1.5% [95% CI: 7.4, 4.6]). A major secondary endpoint in these two trials evaluated the percentage of ITT patients achieving a ≥20% reduction in lesion area from baseline at 48–72 hours after initiation of therapy. In Trial 1, 89.9% of the Dalvance treatment group met the secondary endpoint as compared to 90.9% in the Vancomycin/Linezolid treatment group (treatment difference 1.0% [95% CI: 5.7, 4.0]). In Trial 2, 87.6% of the Dalvance treatment group met the secondary endpoint as compared to 85.9% in the Vancomycin/Linezolid treatment group (treatment difference 1.7% [95% CI: 3.2, 6.7]). For more clinical trial data, see full labeling. Legal Classification: Rx Adults: Give by IV infusion over 30 minutes. Initially 1000mg, followed by 500mg one week later. Renal impairment (CrCl <30mL/min) and who are not receiving hemodialysis: initially 750mg followed by 375mg one week later. Children: Not established. Warnings/Precautions: History of glycopeptide allergy. Discontinue if serious hypersensitivity or skin reactions occur. Risk of Clostridium difficile-associated diarrhea; discontinue if suspected or confirmed. Moderate or severe hepatic impairment (Child-Pugh Class B or C). Renal impairment (CrCl <30mL/min). Pregnancy (Category C). Nursing mothers. Adverse Reaction(s) Nausea, headache, diarrhea, vomiting, rash, pruritus; ALT elevations, infusion-related reactions (eg, Red-Man Syndrome), C. difficile-associated diarrhea. How Supplied: Single-use vial—1 LAST UPDATED: 9/9/2014 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4b4674d8-4d1e-4728-8465-d42ada33fa5c