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Avycaz(ceftazidime-avibactam) for injection头孢他啶阿维巴坦注射液
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Avycaz（ceftazidime-avibactam) for injection头孢他啶阿维巴坦注射液
2015年2月27日，新型抗生素产品Avycaz获得FDA批准，用于复杂性腹腔内感染 (cIAI)（联合甲硝唑）及复杂性尿路感染 (cUTI) 的治疗。此前，FDA已授予Avycaz合格传染病产品 (QIDP)资格，并根据II期临床数据进行了优先审查，因此Avycaz应保守用于有限或无替代治疗方案的患者群体。该药的III期临床正在进行中，相关数据将用于支持Avycaz的标签扩展。
Avycaz（ceftazidime-avibactam，头孢他啶-阿维巴坦）是由一种广谱头孢菌素（ceftazidime）与一种新型β-内酰胺酶抑制剂 (avibactam) 组成的复方产品，开发用于治疗革兰氏阴性细菌感染，包括对现有抗生素产品有耐药性的广谱β-内酰胺酶及肺炎克雷伯杆菌碳青霉烯酶。Avycaz原本由森林实验室（Forest Lab）和阿斯利康联合开发，但去年2月，阿特维斯耗资250亿美元收购Forest Lab后将Avycaz收入囊中。根据协议，阿特维斯拥有Avycaz在北美市场的权利，阿斯利康拥有Avycaz在全球其他地区的权利.
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Drug Name(s) |
AVYCAZ |
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FDA Application No. |
(NDA) 206494 |
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Active Ingredient(s) |
CEFTAZIDIME;AVIBACTAM |
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Company |
CEREXA |
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Original Approval or Tentative Approval Date |
February 25, 2015 |
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Chemical Type |
1 New molecular entity (NME) |
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Review Classification |
P Priority review drug |
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AVYCAZ |
CEFTAZIDIME;AVIBACTAM |
2G; 0.5G |
INJECTABLE;INJECTION |
Prescription |
TBD  |
TBD |
View the label approved on 02/25/2015 (PDF) for AVYCAZ, NDA no. 206494
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Drug Name(s) |
AVYCAZ |
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FDA Application No. |
(NDA) 206494 |
|
Active Ingredient(s) |
CEFTAZIDIME;AVIBACTAM |
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Company |
CEREXA |
Indications and Usage
Complicated Intra-Abdominal Infections (cIAI)
AVYCAZ™ (ceftazidime-avibactam), in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Providencia stuartii, Enterobacter cloacae, Klebsiella oxytoca, and Pseudomonas aeruginosa in patients 18 years or older.
As only limited clinical safety and efficacy data for AVYCAZ are currently available, reserve AVYCAZ for use in patients who have limited or no alternative treatment options.
Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
AVYCAZ is indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Citrobacter freundii, Proteus spp., and Pseudomonas aeruginosa in patients 18 years or older.
As only limited clinical safety and efficacy data for AVYCAZ are currently available, reserve AVYCAZ for use in patients who have limited or no alternative treatment options.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVYCAZ and other antibacterial drugs, AVYCAZ should be used to treat only indicated infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Important Safety Information
Contraindications
AVYCAZ is contraindicated in patients with known serious hypersensitivity to AVYCAZ, avibactam-containing products, ceftazidime, or other members of the cephalosporin class.
WARNINGS AND PRECAUTIONS
•In a Phase 3 complicated intra-abdominal infections (cIAI) trial, clinical cure rates were lower in a subgroup of patients with baseline creatinine clearance (CrCL) of 30 to 50 mL/min compared to those with CrCL greater than 50 mL/min. The reduction in clinical cure rates was more marked in patients treated with AVYCAZ plus metronidazole compared to meropenem-treated patients. Within this subgroup, patients treated with AVYCAZ received a 33% lower daily dose than is currently recommended for patients with CrCL 30 to 50 mL/min. Monitor CrCL at least daily in patients with changing renal function and adjust the dosage of AVYCAZ accordingly.
•Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with AVYCAZ is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. Exercise caution if this product is to be given to a penicillin or other beta-lactam-allergic patient because cross sensitivity among beta-lactam antibacterial drugs has been established. Discontinue the drug if an allergic reaction to AVYCAZ occurs.
•Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs, including AVYCAZ, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial drugs. If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible.
•Seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in patients treated with ceftazidime, particularly in the setting of renal impairment. Adjust dosing based on creatinine clearance.
•Prescribing AVYCAZ in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
ADVERSE REACTIONS
•The most common adverse reactions (incidence of ≥10% in either indication) were vomiting, nausea, constipation, and anxiety. |
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