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”。
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). 
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. eva luate 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 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.
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 eva luated 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