Delafloxacin

Delafloxacin inhibits bacterial DNA topoisomerase IV and DNA gyrase (topoisomerase II) enzymes, which are required for bacterial DNA replication, transcription, repair, and recombination. It exerts concentration-dependent bactericidal activity. Delafloxacin is active against a wide range of bacteria including Staphylococcus aureus (including MRSA) and Pseudomonas aeruginosa.

• Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
• Community-Acquired Bacterial Pneumonia (CABP)

Delafloxacin inhibits bacterial DNA topoisomerase IV and DNA gyrase (topoisomerase II) enzymes. It interferes with bacterial DNA replication and exerts concentration-dependent bactericidal activity.

Delafloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing bacterial DNA replication and leading to bacterial cell death.

Adult - ABSSSI: 300 mg IV every 12 hours for 5-14 days; OR 450 mg PO every 12 hours for 5-14 days.
Adult - CABP: 300 mg IV every 12 hours for 5-10 days.
Severe renal impairment (eGFR 15-29): 200 mg IV every 12 hours.

IV: Reconstitute 300 mg vial with 10.5 mL D5W or 0.9% NaCl, dilute to 250 mL, infuse over 60 minutes. PO: May take with or without food.

If a dose is missed, take it within 4 hours; if more than 4 hours, wait until the next scheduled dose.

Common (1-10%): Nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%), vomiting (2%).
Other (<2%): Sinus tachycardia, palpitations, tinnitus, vertigo, blurred vision, infusion site reactions, abdominal pain, hypersensitivity, myalgia, dizziness, anxiety, insomnia, pruritus, rash.

Fluoroquinolones are associated with disabling and potentially irreversible serious reactions (tendinitis, tendon rupture, arthralgia, peripheral neuropathy, CNS effects). Risk of tendinitis and tendon rupture in all ages. Risk of peripheral neuropathy. CNS reactions (convulsions, increased intracranial pressure, hallucinations, depression, suicidal thoughts). May exacerbate muscle weakness in myasthenia gravis. Hypersensitivity reactions.

Documented hypersensitivity to delafloxacin or other fluoroquinolones.

Antacids containing aluminum or magnesium, sucralfate, iron, zinc: May substantially interfere with absorption and decrease systemic exposure.

May take with or without food. Caution is advised when consuming alcohol.

There are limited data on the use of Delafloxacin in pregnant women. Please consult your doctor.

It is unknown whether Delafloxacin is distributed in human breast milk. Please consult your doctor.

Safety and efficacy in people under 18 years of age have not been established; use is not recommended.

Elderly patients are at increased risk for tendon disorders and aortic aneurysm; caution is required.

Renal impairment (IV): CrCl 30-89: No dose adjustment; CrCl 15-29: 200 mg IV q12hr; CrCl <15: Not recommended.
Hepatic impairment: No dosage adjustment necessary.

Treatment of overdose should consist of observation and general supportive measures. Hemodialysis removes about 19% of Delafloxacin and 56% of SBECD.

Store at 20°C-25°C in a dry place, protected from light. Reconstituted vial may be stored for up to 24 hours (refrigerated or at room temperature). Do not freeze.

Delafloxacin