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NUZYRA(omadacycline injection/tablets)

2018-10-07 03:28:05  作者:新特药房  来源:互联网  浏览次数:6  文字大小:【】【】【
简介:——新型抗生素Nuzyra(omadacycline获美国FDA批准上市近日,美国FDA批准Paratek公司研发的创新抗生素Nuzyra(omadacycline)上市,用于治疗社区获得性细菌性肺炎(CABP)和急性皮肤和皮肤结构感染(AB ...

——新型抗生素Nuzyra(omadacycline获美国FDA批准上市
近日,美国FDA批准Paratek公司研发的创新抗生素Nuzyra(omadacycline)上市,用于治疗社区获得性细菌性肺炎(CABP)和急性皮肤和皮肤结构感染(ABSSSI)的成人患者。Nuzyra是一种四环素类的创新广谱抗生素,可以通过静脉注射或者口服给药。
根据美国疾病预防与控制中心(CDC)估计,耐药性细菌每年在美国导致200万人次感染和2.3万人的死亡。导致CABP的主要菌种肺炎链球菌(Streptococcus pneumoniae),每年会造成120万人次感染和七千人死亡,而ABSSSI会导致超过75万人住院。随着细菌对抗生素的耐药性不断增强,患者迫切需要有效的新疗法。
Nuzyra是一种每日一次,通过静脉注射或者口服给药的创新抗生素。它被特别设计成能够克服细菌对四环素的耐药性,而且对广谱细菌都可以表现出活性,包括革兰氏阳性和阴性菌,非典型细菌和其它耐药菌株。
批准日期:
2018年10月4日 公司:Paratek Pharmaceuticals
NUZYRA(omadacycline)注射用,用于静脉注射
NUZYRA(omadacycline)片剂,用于口服
美国最初批准:2018年
作用机制
NUZYRA是一种抗菌药物[见微生物学]
适应症和用法
NUZYRA是一种四环素类抗菌药,适用于治疗由易感微生物引起的下列感染的成年患者:
社区获得性细菌性肺炎(CABP)。
急性细菌性皮肤和皮肤结构感染(ABSSSI)。
为了减少抗药性细菌的发展并保持NUZYRA和其他抗菌药物的有效性,NUZYRA应该仅用于治疗或预防被证实过度怀疑是由易感细菌引起的感染。
剂量和给药
NABZYRA在CABP和ABSSSI成人患者中的用量:
  感染          装载剂量                维持剂量
CABP 
     第1天:200毫克     静脉注射100毫克
                   静脉滴注               输液超过30分钟
          60分钟或100毫克          每日一次或300毫克
                   静脉滴注                 每天口服一次
                  两次30分钟
ABSSSI   第1天:200毫克    静脉注射100毫克
                    静脉滴注               输液超过30分钟
            60分钟或100毫克       每日一次或300毫克
                    静脉滴注               每天口服一次
                  两次30分钟OR
ABSSSI     第1天和第2天:   每日口服300毫克
(NUZYRA
    450毫克
tablet         每天口服一次
sonly)
CABP和ABSSSI:
治疗持续时间为7至14天。
快速至少4小时,然后服用NUZYRA片剂加水。
口服给药后,2小时内不得食用任何食物或饮料(水除外),4小时内不得食用乳制品,抗酸剂或多种维生素。
有关NUZYRA IV的准备和其他管理说明,请参阅完整的处方信息。
剂量形式和强度
用于注射:100 mg omadacycline(相当于131 mgomadacycline tosylate)作为冻干粉末,在单剂量小瓶中重新配制并在静脉输注前进一步稀释
片剂:150 mg omadacycline(相当于196 mg omadacyclinetosylate)
禁忌症
已知对Omadacycline,四环素类抗菌药物或NUZYRA中任何赋形剂的超敏反应。
警告和注意事项
CABP患者的死亡率不平衡:在CABP试验中,NUZYRA治疗患者的死亡率为2%,莫西沙星治疗患者的死亡率为1%。造成永生不平衡的原因尚未确定。密切监测CABP患者对治疗的临床反应,特别是那些患者死亡风险较高。
牙齿变色和牙釉质发育不良:NUZYR的使用牙齿发育(妊娠的后半部分,婴儿期和婴儿期至8岁)可能导致牙齿永久性变色(黄灰棕色)和牙釉质发育不全。
抑制骨骼生长:在怀孕的第二和第三个三个月,婴儿期和儿童期间使用NUZYRA可达到8年,这可能会导致骨骼生长的可逆抑制。
艰难梭菌相关性腹泻:评估腹泻是否发生。
不良反应
最常见的不良反应(发生率≥2%)是恶心,呕吐,输液部位反应,丙氨酸氨基转移酶增加,天冬氨酸转氨酶增加,γ-谷氨酰转移酶增加,高血压,头痛,腹泻,失眠和便秘。
要报告疑似不良反应,请致电1-833-727-2835联系ParatekPharmaceuticals,Inc。或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
药物相互作用
接受抗凝治疗的患者在服用NUZYRA时可能需要向下调整抗凝剂剂量。
四环素(包括NUZYRA)的吸收损害了含有铝,钙或镁,水杨酸铋和含铁制剂的含酸。
用于特定人群
哺乳期:在使用NUZYRA治疗期间不建议母乳喂养。
包装提供/存储和处理
提供
注射用NUZYRA
注射用NUZYRA作为无菌冻干粉末在单剂量无色玻璃小瓶中提供,每个小瓶含有100mg NUZYRA(相当于131mg omadacycline甲苯磺酸盐)。
它们按如下方式提供:100毫克单剂量小瓶(NDC 71715-001-02),包装在10个纸盒中。
NUZYRA片剂
NUZYRA片含有150毫克的omadacycline(相当于196毫克omadacycline甲苯磺酸盐)黄色,菱形,薄膜包衣片,一面用OMC压印,另一面用150片压印。
它们的供货如下:30片装有儿童防护帽的瓶子(NDC 71715-002-12)。
存储和处理
注射用NUZYRA和NUZYRA片剂应储存在20°C至25°C(68°F至77°F);允许偏移15°C至30°C(59°F至86°F)[见USP Controlled 室温] [见剂量和管理]。 不要冻结。


完整资料附件:https://www.nuzyra.com/PI.pdf
FDA Approval of NUZYRA™ (Omadacycline)
NUZYRA™ (Omadacycline)First and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSI patients in nearly 20 Years
U.S. Food and Drug Administration (FDA) has approved NUZYRA™ (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). NUZYRA, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains.
“In the face of ever-increasing antibiotic resistance, the FDA approved NUZYRA with a label having full approval for both CABP and ABSSSI.  We are excited to bring to physicians an effective, well-tolerated monotherapy option for patients,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “NUZYRA offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays.”
The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States. The main bacteria causing CABP, Streptococcus pneumoniae, is responsible for 1.2 million infections and 7,000 deaths, whereas ABSSSI is responsible for more than 750,000 hospitalizations. The increase of antibiotic resistance continues to drive the need for new, effective therapies.
“Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients,” said Keith Kaye, M.D., MPH, Director of Clinical Research, Division of Infectious Diseases, University of Michigan. “There continues to be a need for novel antibiotics with both IV and oral formulations, such as NUZYRA, to help physicians stay ahead of the evolving resistance landscape.”
About NUZYRA
NUZYRA (omadacycline) is a novel antibiotic with both once-daily intravenous (IV) and oral formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.
Indications and Usage
NUZYRA™ is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Important Safety Information
Contraindications
NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.
Warnings and Precautions
Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin.  The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities.  The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.
The use of NUZYRA 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 NUZYRA 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.
Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs.  NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.
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. Evaluate if diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class of 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 NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.
Prescribing NUZYRA 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 ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.
Drug Interactions
Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.
Use in Specific Populations
Lactation: Breastfeeding is not recommended during treatment with NUZYRA.

责任编辑:p53


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