Medication Monitor

Generic Name (Trade Name—Company)
October 31, 2019


(Baxdela—Melinta Therapeutics)
FDA approves delafloxacin for treatment of community-acquired bacterial pneumonia

On October 24, FDA approved a new indication for delafloxacin, a fluoroquinolone antibacterial, to treat adult patients with community-acquired bacterial pneumonia (CABP) caused by 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.

Delafloxacin was FDA approved in 2017 to treat adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.

Delafloxacin has a boxed warning cautioning that fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together. These include tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Patients who experience any of these serious adverse reactions should discontinue use immediately. Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis; patients with a known history of myasthenia gravis should avoid use.

The recommended dosage of delafloxacin is 300 mg by I.V. infusion over 60 minutes every 12 hours or a 450-mg tablet orally every 12 hours for 5 to 14 days.

Common adverse reactions are nausea, diarrhea, headache, transaminase elevations, and vomiting.