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近日，以开发新型抗生素治疗严重细菌感染的Melinta公司获美国食品和药物管理局(FDA)已批准其旗下新药Baxdela用于治疗由易感细菌引起的急性细菌性皮肤和皮肤结构感染。为患者提供了一个新的选择。
批准日期： 2017年6月19日:公司：Melinta Therapeutics
BAXDELA(delafloxacin)片，为口服使用。BAXDELA(delafloxacin)注射用，为静脉使用
美国初次批准：2017
作用机制
BAXDELA是一种抗细菌药[见微生物学]。
适应证和用途
BAXDELA是一种氟喹诺酮类抗菌药适用在成年为被指定的一种细菌所致的急性细菌性皮肤和皮肤结构感染(ABSSSI)的治疗。
减低耐药细菌的发展和维持BAXDELA和其他抗菌药的有效性，BAXDELA只应被使用治疗被证明或强烈地怀疑是细菌所致的感染。
剂量和给药方法
● 通过每12小时历时60分钟静脉输注给予注射用BAXDELA 300mg，或每12小时口服一片450-mg BAXDELA片总时间共5至14天。
●对有肾受损患者剂量是根据估算的肾小球滤过率(eGFR)
剂型和规格
● 注射用：300 mg的delafloxacin(等同于433 mg delafloxacin甲基葡胺[meglumine])作为一个冻干粉在一个单次剂量小瓶为静脉输注前重建和进一步稀释。
● 口服片：450 mg delafloxacin(等同于649 mg delafloxacin甲基葡胺)。
禁忌证
已知对BAXDELA或其他氟喹诺酮类[fluoroquinolones]超敏性。
警告和注意事项
● 超敏性反应：首次或随后BAXDELA的给药后可能发生。在一个皮肤皮疹的首次征象或超敏性任何其他的征象终止BAXDELA。
● 艰难梭菌伴随腹泻：如发生腹泻时评价。
不良反应
最常见不良反应(发生率 ≥ 2%)是恶心，腹泻，头痛，转氨酶升高和呕吐。
报告怀疑不良反应，联系Melinta Therapeutics电话(844) 635-4682或FDA电话1-800-FDA-1088或www.fda.gov/medwatch。
特殊人群中使用
肾受损：密切地监视血清肌酐水平在有严重肾受损患者(eGFR 15-29 mL/min/1.73 m2)接受静脉delafloxacin。如血清肌酐水平发生增加，考虑改变至口服delafloxacin。如eGFR减低至<15 mL/min/1.73 m2终止BAXDELA。
包装规格/贮存和处置
注射用BAXDELA
BAXDELA作为一个无菌，冻干粉在单次-剂量清晰玻璃小瓶300 mg delafloxacin(等同于433 mg delafloxacin甲基葡胺)供应。冻干粉是一个淡黄色至棕黄色饼，它可能纹理和颜色可能有裂纹和邹缩轻微变异。
供应如下：300-mg一次性-剂量小瓶(NDC 70842-102-03)，包装在10个纸盒。
BAXDELA片
BAXDELA片含450 mg delafloxacin(等同于649 mg delafloxacin甲基葡胺)；各修饰胶囊-形片在米色至斑驳的米色在一侧凹陷有RX3341。它们被供应如下：
20片瓶有防儿童密封(NDC 70842-101-01)
含20片单位剂量吸塑包装(2个吸塑卡各10片)(NDC 70842-101-02)
贮存和处置
BAXDELA片和注射用BAXDELA 应被贮存在20°C至25°C(68°F至77°F)；外出允许至15°C至30°C(59°F至86°F)[见USP控制室温度]。
重建的粉可被贮存共至24小时在冰箱或控制室温度和然后进一步稀释为静脉输注。在输注袋中重建的溶液可被贮存在冰箱或控制室温度条件共至24小时[见剂量和给药方法]。不要冻结。
完整处方资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb77637a-88d9-4aea-958f-e270030ce30d
BAXDELA™ (delafloxacin) is FDA approved in the US for the treatment of serious skin infections
BAXDELA™ (delafloxacin) is FDA approved in the US for the treatment of serious skin infections known as acute bacterial skin and skin structure infections (ABSSSI).
For more information about Baxdela for treatment of ABSSSI, please visit www.Baxdelarx.com.
Baxdela is an anionic fluoroquinolone antibiotic, a class currently used in one out of three hospital-treated infections. Baxdela has demonstrated in-vitro and clinical activity against Gram-positive and Gram-negative pathogens, including activity against MRSA (methicillin-resistant Staphylococcus aureus), a major cause of hospital-treated skin infections. Baxdela provides for convenient administration with both intravenous and oral forms.
Baxdela is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:
Gram-positive organisms.
Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis;
Gram-negative organisms.
Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
WARNINGS AND PRECAUTIONS:
Tendinitis and Tendon Rupture, Peripheral Neuropathy, Central Nervous System Effects, Exacerbation of Myasthenia Gravis, Hypersensitivity Reactions, and Clostridium difficile-Associated Diarrhea, and Development of Drug-Resistant Bacteria.
CONTRAINDICATIONS:
Baxdela is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs, or any of the components of Baxdela.
ADVERSE REACTIONS:
Most common adverse reactions (incidence ≥ 2%) are nausea, diarrhea, headache, transaminase elevations and vomiting.
Development Status for New Indications
Melinta is conducting a Phase 3 clinical program in serious community-acquired bacterial pneumonia (CABP) and may develop additional indications such as complicated urinary tract infections (cUTI). Quinolones are considered a standard of care in the treatment of CABP and cUTI. Baxdela is not currently FDA approved for the treatment of CABP or cUTI.
Melinta has received Qualified Infectious Disease Product (QIDP) designation from the U.S. FDA for the ABSSSI and CABP indications, which provides Baxdela with priority review and extends its market exclusivity period by an additional 5 years beyond the 5 years provided by Hatch-Waxman legislation. Melinta has partnerships in place for delafloxacin outside the US.
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