Eraxis(Anidulafungin)
INTRODUCTION
Over the last 25 years, the incidence of fungal infections has increased dramatically. Predominantly a nosocomial complication, invasive fungal infections are growing in the expanding population of at-risk hospitalized patients. The greatest risk lies in the ever-increasing number of immunocompromised patients, including patients with human immunodeficiency virus (HIV) infection and those receiving chemotherapy or other immunosuppressive agents.
Although Candida species remain the most common cause of fungal infections, the epidemiology of invasive fungal infections has changed. The frequency and relative importance of infections caused by Aspergillus are increasing. The lungs are the most common site of primary invasive disease, followed by the central nervous system (CNS).
A shift has also been seen in the infections caused by candidal organisms. Candida albicans remains the most common pathogen associated with noninvasive disease, such as esophageal or vaginal candidiasis, but non-albicans species of Candida are increasingly associated with invasive candidiasis. This is of particular concern because Candida infections are now the fourth leading cause of noso-comial bloodstream infections in the U.S., and non-albicans species are often less susceptible to conventional therapy with azoles or amphotericin B.
In addition to concerns regarding efficacy of existing antifungal agents, problems of tolerability also exist. Ampho-tericin B is associated with significant nephrotoxicity, whereas the azoles have been associated with hepatotoxicity and drug-drug interactions.
Caspofungin (Cancidas, Merck) was the first of the echinocandin antifungal agents to be licensed; micafungin (My-camine, Astellas) received Food and Drug Administration (FDA) approval in March 2005. Micafungin is thus the second in the class of echinocandins to be approved, making anidulafungin the third. The Food and Drug Administration (FDA) approved anidulafungin in February 2006 for the treatment of candidemia, esophageal candidiasis, and intra-abdom-inal abscess and peritonitis caused by candidal infection. Although more data are needed to determine whether ani-dulafungin offers any clinical advantage over the existing agent in this class, one large in vitro surveillance study of C. albi-cans bloodstream isolates showed that anidulafungin was eight-fold to 16-fold more effective than caspofungin.
Generic Name for ERAXIS
Anidulafungin 50mg/vial; pwd for IV infusion after reconstitution and dilution; preservative-free; contains fructose and mannitol.
Legal Classification:
Rx
Pharmacological Class for ERAXIS
Glucan synthesis inhibitor (echinocandin).
Manufacturer of ERAXIS
Pfizer Labs
Indications for ERAXIS
Candidemia. Esophageal candidiasis. Other Candida infections (intra-abdominal abscess, peritonitis).
Adult dose for ERAXIS
Give by IV infusion; max rate 1.1mg/minute. Candidiasis, intra-abdominal abscess, peritonitis: 200mg on day 1, then 100mg/day for at least 14 days after last positive culture. Esophageal candidiasis: 100mg on day 1, then 50mg/day for at least 14 days and at least 7 days after symptom resolution.
Children's dosing for ERAXIS
Not recommended.
Warnings/Precautions for ERAXIS
Follow-up if hepatic dysfunction develops. Pregnancy (Cat.C). Nursing mothers.
Adverse Reactions for ERAXIS
Infusion reactions.
How is ERAXIS supplied?
Vial (w. diluent)—1
Eraxis(Anidulafungin)-阿尼芬净
美国FDA批准真菌感染的新疗法Eraxis(anidulafungin)
FDA批准了Eraxis™(通用名：阿尼芬净[anidulafungin])用于治疗假丝酵母（Candida）引起的某些感染。Candida是一种能在就医病人或免疫系统受损的病人中引起严重感染的类似酵母的真菌。
“该产品为与假丝酵母相关的几种感染提供了一种新的可选疗法”，FDA的药品评价与研究中心主任Steven Galson博士称。“它是现有用于治疗这些潜在的严重真菌病症的抗菌药物的有益补充。”
一种从未在美国上市的新分子实体Eraxis，是一种静脉注射的抗真菌药物，并被用于治疗食道（念珠菌病）、血液（念珠菌血症）中的假丝酵母感染以及其他类型的假丝酵母感染，包括腹部脓肿和腹膜炎（腹腔内壁发炎）。
临床研究评价了Eraxis的安全性和有效性，并且显示Eraxis在食道念珠菌病、念珠菌血症（candidemia）以及其他包括腹部脓肿和腹膜炎在内的假丝酵母感染的治疗中是安全且有效的。
Eraxis在临床研究中普遍很耐受。最常见报告的不良事件是：轻度腹泻，肝酶的实验室测试水平轻微上升，以及头痛。一些病人经历了与输液相关的反应，其中多数为轻度。在具有重大的潜在医学状况的且正伴服多重药物的少数病人中，有严重肝异常的报道。
Eraxis由纽约州的Pfizer公司生产。
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原产地英文商品名:
ERAXIS(WATER DIL) 100mg/vial
原产地英文药品名:
ANIDULAFUNGIN
中文参考商品译名:
助霉飞(DIL水) 100毫克/瓶
中文参考药品译名:
阿尼芬净
生产厂家中文参考译名:
辉瑞
生产厂家英文名:
PFIZER
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原产地英文商品名:
ERAXIS(WATER DIL) 50mg/vial
原产地英文药品名:
ANIDULAFUNGIN
中文参考商品译名:
助霉飞(DIL水) 50毫克/瓶
中文参考药品译名:
阿尼芬净
生产厂家中文参考译名:
辉瑞
生产厂家英文名:
PFIZER
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原产地英文商品名:
ERAXIS 100mg/vial
原产地英文药品名:
ANIDULAFUNGIN
中文参考商品译名:
助霉飞 100毫克/瓶
中文参考药品译名:
阿尼芬净
生产厂家中文参考译名:
辉瑞
生产厂家英文名:
PFIZER
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原产地英文商品名:
ERAXIS 50mg 100mg
原产地英文药品名:
ANIDULAFUNGIN
中文参考商品译名:
助霉飞 50毫克/瓶
中文参考药品译名:
阿尼芬净
生产厂家中文参考译名:
辉瑞
生产厂家英文名:
PFIZER