About BAXDELA

Explore Your Path Forward With BAXDELA® (delafloxacin)

INDICATION & USAGE:

BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: 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, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

BAXDELA is indicated in adults for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

Demonstrated Safety Profile

  • No evidence of QT prolongation was observed in patients taking BAXDELA 300 or 900 mg IV in a definitive QT study vs oral moxifloxacin 400 mg or placebo
  • No clinically significant phototoxic potential was observed in BAXDELA 200 or 400 mg/day oral in a photosafety study vs lomefloxacin as the active comparator
  • Minimal potential for drug interactions demonstrated during development
    • No drug-drug interactions due to CYP450
    • Oral BAXDELA should be taken 2 hours before or 6 hours after antacids or multivitamins containing iron or zinc
    • Do not administer any solution containing multivalent cations (eg, calcium and magnesium) through the same IV line
  • The most common adverse reactions in patients treated with BAXDELA during Phase 3 trials were nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%), and vomiting (2%)

Next: Efficacy

BAXDELA® is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.