delafloxacin meglumine: clinical use

Prescribing considerations

• Reserve for licensed infections when commonly recommended antibiotics are inappropriate; use microbiology and susceptibility information where available.
• Assess previous fluoroquinolone toxicity, tendon risk, renal function, aortic or valvular disease, neurological or psychiatric disorders, diabetes, myasthenia gravis and G6PD deficiency.
• Avoid concurrent systemic corticosteroids where possible.
• Confirm effective contraception when relevant.
• Clinical evidence is limited in some severely immunocompromised groups and certain presentations of skin infection.

Contraindications and cautions

• Hypersensitivity to delafloxacin, an excipient, or another quinolone or fluoroquinolone.
• Previous fluoroquinolone-related tendon disorder.
• Pregnancy or potential for pregnancy without effective contraception.
• Breastfeeding.
• Children and growing adolescents under 18 years.

Monitoring

• Clinical and microbiological response, including evidence of superinfection.
• Renal function, particularly with intravenous treatment because its cyclodextrin vehicle accumulates in renal impairment.
• Blood glucose in people with diabetes.
• New tendon, neurological, psychiatric, sensory, severe skin or hypersensitivity symptoms.
• Antibiotic-associated diarrhoea and possible Clostridioides difficile infection.
• Liver tests where clinically indicated.

Clinical pharmacology

Delafloxacin inhibits DNA gyrase and topoisomerase IV. It is mainly metabolised by glucuronidation, has minimal oxidative metabolism and a low in-vitro potential for clinically significant CYP-mediated interactions. Oral and intravenous formulations provide comparable total systemic exposure.

Formulation and product differences

• Tablets may be taken with or without food but have chelation interactions with antacids, sucralfate, iron, zinc and other multivalent cations.
• The intravenous powder requires aseptic reconstitution and dilution and must not be co-infused with other medicines; a shared line should be flushed appropriately.
• The intravenous formulation contains sulfobutylbetadex sodium, which can accumulate in renal impairment, and has a higher sodium content than the tablet.
• A clinician-directed switch between intravenous and oral formulations is possible.

Solution for infusion

Route: Intravenous

Strengths: 300 mg

Tablet

Route: Oral

Strengths: 450 mg