[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
- Studies are ongoing for (1) community acquired bacterial pneumonia, and (2) 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