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 详细处方信息以本药内容附件PDF文件（201152300213511.pdf）的“原文Priscribing Information”为准
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部分中文阿尼芬净处方资料（仅供参考）

FDA批准抗真菌药阿尼芬净(anidulafungin)上市
    FDA批准抗真菌药阿尼芬净(anidulafungin,Eraxis)上市
    辉瑞公司2月21日宣布，FDA已批准其在研药物阿尼芬净（anidulafungin，Eraxis）的上市申请，用于念珠菌病的治疗。念珠菌病是最致命的1种常见的医院获得性血液感染，死亡率约40%。
    念珠菌病高危人群包括免疫系统受损患者、干细胞或器官移植接受者以及接受化疗或导尿管放置的患者、接受外科手术患者、长期接受抗菌药物治疗患者及重症监护室中的患者等。在美国，念珠菌病发生率约1/5000，每年导致约6万例感染。感染念珠菌病后患者平均将在医院多住10天，额外多支出39000美元/人。
    本品的获准将充实辉瑞公司的抗感染产品线，特别是抗真菌产品线。长期以来被视为念珠菌和其它真菌感染的金标准药物氟康唑(fluconazole，Diflucan)也是辉瑞的产品。而本品是唯一在临床研究中被证明疗效超过氟康唑的药物。本品原为Vicuron公司所开发，2005年9月该公司被辉瑞收购。

藥品英文名：ERAXIS INJ 

藥品中文名：助黴飛注射劑

主成分名：ANIDULAFUNGIN;

適應症：治療非白血球低下之成人念珠菌血症, 念珠菌腹膜炎及念珠菌腹腔內膿瘍。

可能的副作用：低血鉀、腹瀉

用藥注意事項：
1)原瓶於2-8℃儲存。
2)每100 mg本藥須以30 mL無菌注射用水配製成每毫升3.3 mg的濃度，再以100 mL D5W或NS稀釋後靜脈輸注。
3)輸注速率不可超過1.1 mg/min，100 mg最短輸注時間為90分鐘；輸注溶液於室溫下應於4小時內使用完畢。
4)不可與其他藥物混合。
5)配製後未稀釋溶液，於2-8℃最多儲放1小時。

未開封貯存方法：本品須冷藏貯存
 
特殊使用注意事項：無

    侵袭性真菌感染是越来越多的免疫低下患者死亡的一个重要原因。常见致病菌为白色念珠菌、烟曲菌、热带念珠菌和新型隐球菌。近年来深部真菌感染呈持续增多趋势，这与人类平均寿命延长，肿瘤化疗、器官移植等免疫缺陷患者增多，以及广谱抗生素、肾上腺皮质激素、免疫抑制剂等药物的广泛应用有关。目前仅有3类药物可用于系统性真菌感染的治疗，包括多烯类（两性霉素B），康唑类(伊曲康唑、伏立康唑、泊沙康唑、氟康唑等)，以及棘球白素类（卡泊芬净、阿尼芬净、米卡芬净等）。
    Echinocandin B是生产阿尼芬净的主要原料。阿尼芬净（anidulafungin）于2006年获FDA批准，是第三个上市的棘球白素类药物。

Eraxis (anidulafungin)
Company: Pfizer
Approval Status: Approved February 2006
Treatment for: Fungal infections
Areas: Immunology/Infectious Diseases

General Information
Eraxis (anidulafungin) is an echinocandin semi-synthetic lipopetide, designed to eradicate fungal infections through disruption of enzyme synthesis pathways in these cells without affecting human tissues.

Eraxis is specifically indicated for the treatment of several types of fungal infections: Candidemia; intra-abdominal abscess and peritonitis caused by Candida species; and esophageal candidiasis. The drug has not been studied for the treatment of Candida related endocarditis, osteomyelitis, or meningitis, and efficacy in the treatment of neutropenic patients has not been fully established.

Eraxis is supplied as a lyophilized powder for reconstitution and injection. The recommended initial dose of the drug for the treatment of Candidemia/additional Candida infections is a single loading dose of 200 mg Eraxis on day 1, followed by 100 mg daily thereafter, until clinical response is observed (generally through at least 14 days after the last positive fungal culture). For esophageal candidiasis, recommended dosing is a single loading dose of 100 mg on day 1, followed by 50 mg daily thereafter for at least 14 days and at least 7 days following the resolution of symptoms.

Clinical Results
FDA Approval
Candidemia/Additional Candida Infections
Approval of Eraxis for the treatment of Candidemia and additional Candida infections was based on a phase III trial. This randomized, double-blind, controlled study treated 256 patients with candidemia and/or other forms of invasive candidiasis. Subjects received a fixed dose regimen of either Eraxis (200 mg loading dose/100 mg daily maintenance dose) or fluconazole (800 mg loading dose/400 mg daily maintenance dose) via intravenous infusion for 14 to 42 days. Patients from either arm were permitted to transfer to oral fluconazole following at least 10 days of IV therapy and a negative blood culture. At the end of IV treatment, treatment 75.6% of subjects receiving Eraxis achieved global clinical success, vs. 60.2% for fluconazole. Superiority was maintained at the end of all treatment, (74.0% global success, vs. 56.8%, respectively), and at 2-week (64.6% vs. 49.2%) and 6-week (55.9% vs. 44.1%) follow-ups. All-cause mortality during the study (22.8% vs. 31.4%) all cause mortality during study therapy (7.9% vs. 14.4%), and mortality attributed to Candida (1.6% vs. 4.2%) all showed reductions for Eraxis relative to fluconazole.

Esophageal Candidiasis
Approval of Eraxis for the treatment of esophageal candidiasis was based on a double-blind, double-dummy, randomized phase III trial. 601 subjects were randomized to receive Eraxis (100 mg loading dose/50 mg daily maintenance dose) or fluconazole (200 mg loading dose/100 mg daily maintenance dose) via intravenous infusion. Treatment was administered for a minimum of 14 days, and for 7 days following the resolution of symptoms, through a maximum of 21 days. In both treatment groups, median time to resolution of symptoms was 5 days, and median duration of therapy was 14 days. Endoscopic success (the combined rate of clinical improvement and cure) at the end of therapy (the trial's primary endpoint) was 97.4% for Eraxis and 98.7% for fluconazole; this included cure rates of 88.3% vs. 93.6%, respectively, and improvement rates of 9.1% vs. 5.1%. At 2-weeks post-treatment subjects receiving Eraxis experienced significantly more endoscopically-documented relapses (53.3%) than subjects receiving fluconazole (19.3%).

Ongoing Study Commitments
Deferred pediatric study under PREA for the treatment of candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in pediatric patients ages zero months to sixteen years of age.
Final Report Submission: February 17, 2011

Side Effects
Adverse events associated with the use of Eraxis may include, but are not limited to, the following:
Diarrhea
Hypokalemia
Liver Enzyme Abmormalities
Headache
Rash
Neutropenia
Nausea

Mechanism of Action
Anidulafungin is a semi-synthetic echinocandin designed to inhibit glucan synthase, an enzyme present in fungal (but not mammalian) cells. Inhibition of glucan synthase disrupts formation of 1,3-ß-D-glucan, an essential component of the fungal cell wall.

Additional Information
For additional information regarding Eraxis or Candida fungal infections, please visit the Eraxis web page.

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 详细处方信息以本药内容附件PDF文件（201152300213511.pdf）的“原文Priscribing Information”为准
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