近日，美国食品和药物管理局（FDA）已批准XERAVA(eravacycline) 治疗18岁以上成年人的复杂腹腔内感染（complicated intra-abdominal infections，cIAIs）。
批准日期：2018年8月30日 公司：TetraphasePharmaceuticals Inc
•严重肝功能损害（Child Pugh C）：第1天每12小时1次/kg XERAVA，第2天开始每24小时1 mg/kg总持续时间为4至14天。
要报告疑似不良反应，请致电1-833-7-XERAVA（1-833-793-7282）或FDA 1-800--FDA-1088或www.fda.gov/medwatch联系TetraphasePharmaceuticals Inc.
注射用XERAVA，50毫克/瓶，是一种黄色至橙色，无菌，无防腐剂的粉末，用于单剂量10mL透明玻璃瓶中，配有橡胶塞和铝质外壳。 每个小瓶含有50mg的eravacycline（相当于63.5mg的eravacyclinedihydrochloride）。 XERAVA提供两种包装配置：
TETRAPHASE PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF XERAVA™ (ERAVACYCLINE) FOR COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI)
U.S. Food and Drug Administration (FDA) has granted approval of XERAVA™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). In clinical trials, XERAVA was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem.
XERAVA is indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older. To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Important Safety Information
XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.
XERAVA is not indicated for the treatment of complicated urinary tract infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline or to tetracycline-class antibacterial drugs. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.
The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.
The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.
XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti‑anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.
XERAVA (eravacycline for injection) is a novel, fully-synthetic fluorocycline, FDA-approved antibiotic for the treatment of cIAI. XERAVA has demonstrated potent activity against MDR pathogens.
XERAVA was investigated for the treatment of cIAI as part of the Company's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) phase 3 programs. In the first pivotal phase 3 trial in patients with cIAI, twice-daily intravenous (IV) eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second phase 3 clinical trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.
About Tetraphase Pharmaceuticals, Inc.
Tetraphase is a biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening bacterial infections, including those caused by many of the MDR bacteria highlighted as urgent public health threats by the WHO and CDC. The Company has created more than 3,000 novel tetracycline compounds using its proprietary technology platform. Tetraphase's lead product, XERAVA™ (eravacycline) is FDA-approved for the treatment of complicated intra-abdominal infections (cIAI), has received a positive opinion from the CHMP for cIAI, and is under consideration for potential marketing approval by the European Commission for cIAI.