BLACK BOX WARNING
- tendinitis and tendon rupture
- peripheral neuropathy
- CNS effects
- exacerbation of myasthenia gravis
delafloxacin
Brand: Baxdela
⚠ BBW Prototype: ciprofloxacin
Drug Class: fluoroquinolone antibiotic
Drug Family: antibiotic
Subclass: anionic fluoroquinolone with enhanced acidic environment activity
Organ Systems: infectious-diseaserespiratory
Mechanism of Action
Inhibits DNA gyrase and topoisomerase IV; unique anionic structure enhances activity in acidic environments (abscesses, infected tissues), including against MRSA. More potent against gram-positive organisms than other fluoroquinolones while retaining gram-negative activity.
DNA gyrase (topoisomerase II)topoisomerase IV
Indications
- acute bacterial skin and skin structure infections (ABSSSI) including MRSA
- community-acquired bacterial pneumonia (CABP)
Contraindications
- fluoroquinolone hypersensitivity
Adverse Effects
Common
- nausea
- diarrhea
- headache
- elevated LFTs
Serious
- tendinopathy/rupture
- peripheral neuropathy
- QTc prolongation (less than moxifloxacin)
- C. difficile colitis
- CNS effects
Pharmacokinetics (ADME)
| Absorption | oral or IV; oral bioavailability ~58% |
| Distribution | large Vd; concentrated in tissues and acidic environments |
| Metabolism | primarily by glucuronidation and renal excretion |
| Excretion | renal (~50% IV) and fecal (~28%); dose adjustment for severe renal impairment |
| Half-life | 3.7–8.5 hours |
| Onset | rapid |
| Peak | 0.75 hours (IV), 1 hour (oral) |
| Duration | 12 hours |
| Protein Binding | 84% |
| Vd | large |
Drug Interactions
| Drug / Agent | Mechanism | Severity |
|---|---|---|
| antacids/sucralfate/iron/zinc | chelation reduces oral absorption; separate by 2 hours | moderate |
| QTc-prolonging drugs | additive QTc prolongation; monitor ECG | moderate |
Nursing Considerations
- Available in both IV and oral formulations enabling step-down therapy; oral bioavailability is lower than levofloxacin, so IV initiation for serious infections is preferred.
- Counsel patients on all fluoroquinolone class black box warnings; particular emphasis on tendon rupture and peripheral neuropathy.
- Dose adjustment is required for patients with eGFR <15 mL/min for the IV formulation (contains SBECD cyclodextrin vehicle that accumulates).
- Monitor for C. difficile infection; delafloxacin has broad-spectrum activity that disrupts gut flora.
Clinical Pearls
- Delafloxacin's anionic charge causes it to concentrate in acidic environments such as abscesses, where many antibiotics lose potency — an advantage for treating difficult-to-drain skin and soft tissue infections.
- Delafloxacin has FDA approval specifically for ABSSSI due to MRSA, distinguishing it from other fluoroquinolones and reflecting its superior gram-positive activity.
Safety Profile
Pregnancy avoid
Lactation avoid
Renal Adjustment Required
Hepatic Adjustment Not required
TDM Not required
Guideline Update pending
Concordance Terms
Cross-referenced clinical concepts — click any term to see all content where it appears.