Baxdela (delafloxacin) is a new oral/IV fluoroquinolone antibiotic in Canada

Baxdela (delafloxacin) is a new broad-spectrum fluoroquinolone antibiotic now available in oral and intravenous (IV) dosage forms in Canada. It is supplied by Xediton Pharmaceuticals as 450 mg oral tablets and a powder for solution for IV infusion in 300 mg single-dose vials.1 The drug has been available in the United States since 2018.2Baxdela has received Health Canada approval for two therapeutic indications. It is indicated for treatment of acute bacterial skin and skin structure infections in adults caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae and Pseudomonas aeruginosa.1 It is also indicated for the treatment of community-acquired bacterial pneumonia in adults caused by the following susceptible microorganisms: Streptococcus pneumoniae, S. aureus (methicillin-susceptible isolates only), K. pneumoniae, E. coli, Ps. aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae.1Delafloxacin inhibits bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes, which are required for bacterial DNA replication, transcription, repair and recombination. It exhibits a concentration-dependent bactericidal activity against gram-positive and gram-negative bacteria in vitro.1The recommended dosage of delafloxacin injection is 300 mg every 12 hours by IV infusion. Patients can then be switched to 450 mg orally every 12 hours at the discretion of the prescribing physician. The recommended oral dosage is 450 mg every 12 hours. The usual duration of therapy is five to 14 days for acute bacterial skin and skin structure infections, or five to 10 days for community-acquired bacterial pneumonia.1 No dosage adjustment is necessary in patients with hepatic impairment. No dosage reduction is required for delafloxacin tablets if eGFR is ≥ 15 or for delafloxacin injection if eGFR is ≥ 30. For eGFR 15–29, the recommended dosage for delafloxacin injection is 200 mg IV every 12 hours, or 200 mg IV every 12 hours, then switching to the 450 mg tablet orally every 12 hours at the discretion of the physician. The drug is not recommended in end stage renal disease (eGFR < 15), including patients on hemodialysis.1To administer delafloxacin, the injection must first be reconstituted and then further diluted prior to administration (consult product monograph for details). Each IV dose should be infused over 60 minutes. The oral tablets can be taken with or without food.1 Diarrhea, nausea, infection, infusion site extravasation, transaminase (AST, ALT) elevations and headache are the most common adverse effects of delafloxacin. The drug also shares potentially serious warnings and precautions of the fluoroquinolone class, including tendinitis and tendon rupture (especially in patients > 60 years of age, those taking corticosteroids, and patients with kidney, heart or lung transplants); exacerbation of muscle weakness in myasthenia gravis (avoid in patients with a history of myasthenia gravis); increased risk of psychiatric adverse reactions; serious hypersensitivity and/or anaphylactic reactions; Clostridium difficile-associated disease (from mild diarrhea to fatal colitis); increased risk of convulsions, increased intracranial pressure, dizziness and tremors; possible increased risk of aortic aneurysm and aortic dissection; peripheral neuropathy; and moderate to severe phototoxicity reactions (avoid excessive exposure to sunlight or UV light). Women of childbearing potential must use effective contraception during treatment with delafloxacin.1In terms of drug interactions, delafloxacin tablets should be administered at least two hours before or six hours after antacids containing magnesium or aluminum, or with sucralfate, metal cations such as iron, or multivitamin preparations containing zinc or iron, or didanosine buffered tablets for oral suspension. For delafloxacin injection, do not administer any solution containing multivalent cations (e.g., calcium, magnesium) through the same IV line.1Baxdela tablets and vials should be stored at 15°C–30°C. Reconstituted vials may be stored for up to 24 hours under refrigerated (2°C–8°C) or controlled room temperature (20°C–25°C) and then further diluted for intravenous infusion. Reconstituted solution in the infusion bag may be stored under refrigerated (2°C–8°C) or controlled room temperature conditions (20°C–25°C) for up to 24 hours.1ReferencesXediton Pharmaceuticals Inc. Baxdela (delafloxacin tablets and delafloxacin for injection) product monograph. Oakville, ON; January 17, 2025. (accessed March 24, 2026).Anon. Delafloxacin (Baxdela) – a new fluoroquinolone antibiotic. Med Lett Drugs Ther 2018;60:49-51.

Baxdela (delafloxacin) is a new oral/IV fluoroquinolone antibiotic in Canada

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