Manufacturer:
Salix Pharmaceuticals, Inc.
Pharmacological Class:
Rifamycin
Active Ingredient(s):
Rifaximin 550mg; tabs.
Indication(s):
Reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age.
Pharmacology:
Hepatic encephalopathy is caused by an accumulation of toxic substances (eg, ammonia) in the blood that may occur when liver function is reduced. Rifaximin, a non-aminoglycoside semi-synthetic antibacterial derived from rifamycin SV, acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase resulting in inhibition of bacterial RNA synthesis. Rifaximin is believed to have an effect on gastrointestinal flora, thereby reducing the intestinal bacteria that is producing the ammonia.
Clinical Trials:
A multicenter, randomized, placebo-controlled, double-blind, 6-month trial was conducted to assess the efficacy of Xifaxan 550mg in reducing the recurrence of overt hepatic encephalopathy episodes. The study enrolled 299 adult patients who experienced ≥2 episodes of hepatic encephalopathy associated with chronic liver disease in the previous 6 months and who were defined as being in remission (Conn score 0 or 1).
Efficacy of Xifaxan 550mg was assessed by the time to first breakthrough overt hepatic encephalopathy episode (defined as marked deterioration in neurological function and Conn score ≥2). During the 6-month treatment period, breakthrough overt hepatic encephalopathy episodes were experienced by 22% of patients treated with Xifaxan 550mg compared to 46% of patients who received placebo. Comparison of Kaplan-Meier estimates of event-free curves showed that Xifaxan 550mg significantly reduced the risk of hepatic encephalopathy breakthrough by 58% during the 6-month treatment period.
Legal Classification:
Rx

Adults:
≥18yrs: 550mg twice daily.

Children:
<18yrs: not recommended.
Warnings/Precautions:
Not studied in patients with MELD scores >25; only 8.6% of patients in the controlled trial had MELD >19. Increased systemic exposure in patients with more severe hepatic dysfunction; caution should be exercised in patients with severe hepatic impairment (Child-Pugh C). Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Adverse Reaction(s):
Peripheral edema, nausea, dizziness, fatigue, ascites.

How Supplied:
Tabs—60

美国食品药品管理局FDA于2010年3月24日宣布，它已批准将Xifaxan利福昔明 用于晚期肝病患者，作为降低其显性肝性脑病HE复发风险的一种手段。Xifaxan之前曾被批准用于治疗旅行者腹泻。
一项随机安慰剂对照临床试验证实了Xifaxan用于预防HE的有效性，该试验的受试者由来自美国、加拿大和俄罗斯的成年肝病患者组成。Xifaxan在最严重肝病患者中的疗效未被研究。试验受试者从未或仅出现过轻微的HE症状。与接受安慰剂对照的受试者相比，接受Xifaxan治疗的患者在试验期间更少出现HE。然而，由于大部分患者在试验期间同时还在服用乳果糖，所以尚无法评估Xifaxan作为HE的一种独立疗法的疗效。
使用Xifaxan治疗肝病患者所报告的最常见不良反应包括外周性水肿、恶心、打嗝及头痛。

Learn how Xifaxan 550 mg reduces risk of overt HE recurrence.
IMPORTANT SAFETY INFORMATION
XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age. In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. XIFAXAN has not been studied in patients with MELD scores >25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
The most common adverse reactions occurring in >8% of patients in the clinical study were edema peripheral (15%), nausea (14%), dizziness (13%), fatigue (12%), ascites (11%), muscle spasms (9%), pruritus (9%), and abdominal pain (9%).
Xifaxan550 is not available for sale outside the U.S.
Xifaxan550 is licensed by Alfa Wassermann S.p.A. to Salix Pharmaceuticals, Inc.

Xifaxan 550mg片剂获得批准用于降低≥18岁患者的肝性脑病（hepatic encephalopathy，HE）复发的风险。此项批准是基于一项在299例患者中进行的双盲、安慰剂对照、国际多中心Ⅲ期临床试验。该试验证明Xifaxan 550mg片剂在统计学上和临床上均可显著降低HE复发风险。
FDA批准利福昔明（Xifaxan）治疗肝性脑病新适应症
利福昔明(Rifaximin)为利福霉素的衍生物，通过与细菌DNA-依赖RNA聚合酶的β-亚单位不可逆的结合而抑制细菌RNA的合成，最终抑制细菌蛋白质的合成。是第一个非氨基糖苷类肠道用抗生素。临床主要用于对利福昔明敏感的病原菌引起的肠道感染。
2010年3月25日，美国食品药品管理局（FDA）宣布批准利福昔明（Xifaxan）用于降低肝性脑病（HE）的复发风险。此前Xifaxan曾作为治疗旅行者腹泻药物获批。此次利福昔明作为罕见病药获优先审评的资格并批准此新适应症。
 一项安慰剂随机对照临床试验评估了Xifaxan治疗HE的有效性，该临床试验的受试者由美国、加拿大和俄罗斯的成年患者组成。参加试验的肝病患者为无HE症状或有轻度HE症状者，与使用安慰剂治疗的患者相比，使用Xifaxan治疗的患者更少出现肝性脑病。
Xifaxan在严重肝病患者中的疗效尚未得以确认。在试验过程中，由于大部分患者同时服用了半乳糖甙果糖（一种合成糖，有助于阻止肠道的氨吸收进入血液），因此，无法评估Xifaxan作为单独治疗HE的确切疗效。
Xifaxan的常见不良反应主要为上下肢肿胀（外周性水肿）、恶心、嗳气和头痛。
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【中文参考药品译名】利福昔明
原产地英文商品名】XIFAXAN UNIT DOSE PACK 550mg/tab 60tabs/bottle
【原产地英文药品名】RIFAXIMIN
【中文参考商品译名】
注：以下产品是不同的规格和不同的价格，购买时请以电话咨询为准！
·XIFAXAN单位剂量包装 550毫克/片 60片/瓶
·XIFAXAN单位剂量包装 200毫克/片 100片/瓶
·XIFAXAN 550毫克/片 60片/瓶
·XIFAXAN 200毫克/片 100片/瓶
【生产厂家中文参考译名】SALIX PHARMS
【生产厂家英文名】SALIX PHARMS