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Delafloxacin

[Delafloxacin photo]

KEY POINTS:

  • Delafloxacin (Baxdela) is an anionic fluoroquinolone antibiotic that works by acting on DNA gyrase (toposiomerase-II) and topoisomerase-IV, which are required for bacterial DNA replication, transcription, repair, and recombination
    • Exhibits concentration-dependant bactericidal activity versus Gram-positive and Gram-negative bacteria in vitro
  • FDA-approved in June 2017 for treatment of acute bacterial skin and skin structure infections
  • FDA-approved in October 2019 for community acquired bacterial pneumonia
    • Studies are ongoing for complicated urinary tract infection
  • Has activity versus Gram negative and Gram positive organisms
    • Has activity versus methicillin-resistant Staphylococcus aureus (MRSA)
    • Has activity versus Pseudomonas aeruginosa
  • Is available in oral and injectable formulations
    • Package insert recommends dose for oral as 450 mg twice daily
    • Package insert recommends dose of IV as 300 mg twice daily
      • Manufacturer recommends dose adjustments for injectable, but not the oral formulation
  • Oral formulation should be taken 2 hours before or 6 hours after antacids that contain magnesium or aluminum, iron, etc.
  • Carries warnings for hypersensitivity reaction, Clostridium difficile-associated diarrhea, and development of drug-resistant bacteria
  • The most common adverse reactions are nausea, diarrhea, headache, transaminase elevations, and vomiting
  • Per FDA, should only be used when benefits outweigh potential risks if treating acute sinusitis, acute bronchitis or uncomplicated urinary tract infections
  • FDA boxed warnings: tendonitis, tendon rupture, CNS effects, peripheral neuropathy, can worsen existing myasthenia gravis
  • FDA warnings: hypoglycemia (including coma), altered mental health, aortic dissection
  • Other ADRs to beware: QTC prolongation, photosensitivitity
    • Suicidal thoughts added to drug safety label warning by the FDA in February 2017

RESOURCES

  • Delafloxacin Package Insert
  • Baxdela Manufacturer Webpage
  • Clinical review of delafloxacin: a novel anionic fluoroquinolone (2018)
  • What Is Old Is New Again: Delafloxacin, a Modern Fluoroquinolone (2018)
  • Delafloxacin: design, development and potential place in therapy (2017)
  • Delafloxacin for the treatment of respiratory and skin infections (2015)



Photo source: Melinta Pharmaceutics via www.helio.com

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