近日,新型抗生素产品Dalvance（dalbavancin）注射液获FDA批准上市，用于治疗由革兰氏阳性菌（包括耐甲氧西林金黄色葡萄球菌，MRSA）导致的急性细菌性皮肤和皮肤结构感染（ABSSSI）。 Dalvance是首个也是唯一一个获批用于ABSSSI治疗的双剂量方案的静脉注射（IV）抗生素，首次给药1000mg，随后500mg给药一周，每次给时间大于30分钟。
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”。
批准日期：2014年5月23日；公司：Durata Therapeutics，Inc.
DALVANCE（达巴万星[dalbavancin]）用于注射，用于静脉注射
美国最初批准：2014年 最近的重大变化
警告和注意事项，输液相关反应：07/2018
作用机制
达巴万星是一种抗菌药物[见微生物学]。
适应症和用法
DALVANCE适用于由指定的革兰氏阳性微生物敏感菌株引起的急性细菌性皮肤和皮肤结构感染（ABSSSI）。
为了减少耐药细菌的发展并保持DALVANCE和其他抗菌药物的有效性，DALVANCE应仅用于治疗已被证实或强烈怀疑由易感细菌引起的感染。
剂量和给药
肾功能正常或受损患者的剂量：
估计的CrCl 单剂量方案 双剂量方案
>30mL/min或定期进行血液透析 1500毫克 1000毫克一周后，500毫克
<30mL/min而不是常规血液透析 1125毫克 一周后750毫克，375毫克
静脉输注30分钟以上。
有关重建冻干粉末和注射剂的说明，请参阅完整处方信息。
剂量形式和强度
用于注射：在小瓶中的500mg冻干粉末用于重构。
禁忌症
对达巴万星过敏。
警告和注意事项
已经报道了糖肽类抗菌剂的严重超敏反应（过敏性）和皮肤反应，包括DALVANCE;对已知对糖肽过敏的患者慎用。
糖肽抗菌剂的快速静脉输注可引起反应。
在临床试验中报告了使用DALVANCE治疗的ALT升高。
艰难梭菌相关性腹泻（CDAD）已报道几乎所有全身性抗菌药物，包括DALVANCE。评估腹泻是否发生。
不良反应
DALVANCE治疗患者最常见的不良反应是恶心（4.7％），头痛（3.8％）和腹泻（3.4％）。
要报告疑似不良反应，请致电1-800-678-1605联系Allergan或1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
用于特定人群
肌酐清除率低于30mL/min且未接受定期血液透析的患者需要调整剂量。
包装提供/存储和处理
注射用DALVANCE（达巴万星）以下列包装配置提供：
500毫克/小瓶：1包（NDC 57970-100-01）
注射用未重组的DALVANCE（达巴万星）应储存在25ºC（77ºF）; 允许偏移15至30ºC（59至86ºF）[见USP受控室温]。
完整说明资料附件： https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4b4674d8-4d1e-4728-8465-d42ada33fa5c。
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).
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
Important Safety Information
Contraindications
DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.
Warnings and Precautions
HYPERSENSITIVITY REACTIONS
Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DALVANCE should be discontinued.
INFUSION-RELATED REACTIONS
Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.
HEPATIC EFFECTS
ALT elevations with DALVANCE treatment were reported in clinical trials.
CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. eva luate if diarrhea occurs.
DEVELOPMENT OF DRUG-RESISTANT BACTERIA
Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
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
•There have been no adequate and well-controlled studies with DALVANCE in pregnant or nursing women. DALVANCE should only be used if the potential benefit justifies the potential risk in these populations.
•In patients with renal impairment whose known creatinine clearance is less than 30 mL/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.
•Caution should be exercised when prescribing DALVANCE to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients.
