BAXDELA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BAXDELA (BAXDELA).
BAXDELA (delafloxacin) is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, leading to inhibition of DNA replication and transcription.
| Metabolism | Delafloxacin is metabolized primarily by glucuronidation via UGT1A1, UGT1A3, and UGT2B15, with minor CYP450 involvement (primarily CYP1A2 and CYP3A4). |
| Excretion | Renal (approximately 65% of dose as unchanged drug) and fecal (approximately 20% as metabolites and unchanged drug). Biliary excretion is minimal. |
| Half-life | Terminal elimination half-life is approximately 9 hours in healthy adults; may be prolonged in patients with renal impairment (up to 20 hours in severe renal impairment). |
| Protein binding | Approximately 84% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution at steady state is approximately 30-50 L (0.4-0.7 L/kg), indicating extensive tissue penetration. |
| Bioavailability | Oral bioavailability is approximately 88% under fasting conditions. |
| Onset of Action | Oral: Clinical effect typically within 24-48 hours of first dose; intravenous: onset within hours of initiation. |
| Duration of Action | Duration of action supports once-daily dosing; clinical effect persists throughout the dosing interval (24 hours). |
Oral: 450 mg (as single tablet) twice daily for 5 days. Intravenous: 450 mg once daily (over 3 hours) or 300 mg twice daily (over 1 hour) for 5 days.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min or hemodialysis: oral dose 450 mg twice daily; IV dose 450 mg once daily (over 3 hours) only. |
| Liver impairment | Child-Pugh A and B: no adjustment. Child-Pugh C: not recommended (no data). |
| Pediatric use | Not approved for patients <18 years; safety and efficacy not established. |
| Geriatric use | No specific dose adjustment; caution due to potential age-related renal impairment and comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BAXDELA (BAXDELA).
| Breastfeeding | It is not known whether delafloxacin is excreted in human breast milk. In animal studies, delafloxacin was present in rat milk. Because fluoroquinolones may cause arthropathy in immature animals, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. The milk-to-plasma (M/P) ratio is unknown in humans. |
| Teratogenic Risk | BAXDELA (delafloxacin) is a fluoroquinolone antibiotic. Fluoroquinolones are associated with an increased risk of musculoskeletal adverse events (arthropathy) in immature animals and human pediatric patients. In pregnant women, data are limited. Based on animal studies, there is evidence of fetal toxicity (e.g., reduced fetal weight, increased skeletal variations) at maternal toxic doses. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, especially in the first and second trimesters when organogenesis occurs. Avoid use in the third trimester unless clearly needed, as fluoroquinolones may cause cartilage damage in the developing fetus. |
■ FDA Black Box Warning
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS AND TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS. Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together. BAXDELA should be discontinued immediately at the first signs of any serious adverse reaction.
| Serious Effects |
["Known hypersensitivity to delafloxacin or any fluoroquinolone","Patients with myasthenia gravis (boxed warning)"]
| Precautions | ["Disabling and potentially irreversible serious adverse reactions (tendinitis, tendon rupture, peripheral neuropathy, CNS effects)","Exacerbation of myasthenia gravis","Hypersensitivity reactions","Clostridioides difficile-associated diarrhea","Photosensitivity/phototoxicity","Risk of aortic aneurysm and dissection"] |
| Food/Dietary | Delafloxacin absorption is reduced by divalent and trivalent cations. Avoid concomitant administration with dairy products (milk, yogurt, cheese), calcium-fortified juices, antacids containing magnesium or aluminum, sucralfate, and iron or zinc supplements. Separate oral BAXDELA by at least 2 hours before or 6 hours after these products. No specific food restrictions beyond cation-containing items. |
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| Fetal Monitoring | Monitor pregnant women receiving BAXDELA for potential fetal effects, including growth restriction and skeletal abnormalities via serial ultrasound. Assess for maternal signs of fluoroquinolone toxicity (e.g., tendonitis, neuropathy, QT prolongation). Pediatric follow-up after birth is recommended to evaluate for musculoskeletal development. |
| Fertility Effects | In animal fertility studies, delafloxacin did not impair fertility or reproductive performance in rats at oral doses up to 6 times the human dose based on AUC. No human data are available. |
| Clinical Pearls | BAXDELA (delafloxacin) is a fluoroquinolone antibiotic with activity against MRSA and Gram-negative pathogens, including Pseudomonas aeruginosa. It is available in both IV and oral formulations with nearly 100% oral bioavailability, allowing for IV-to-oral switch without dose adjustment. Avoid use in patients with known fluoroquinolone hypersensitivity, tendinopathy, or QT prolongation. Monitor for tendon rupture, peripheral neuropathy, CNS effects, and Clostridioides difficile diarrhea. Dose adjustment required for renal impairment (CrCl <30 mL/min) but not for hepatic impairment. |
| Patient Advice | Take oral BAXDELA with or without food, but avoid taking with dairy products, antacids, or iron/zinc supplements as they may reduce absorption. · Complete the full course of therapy even if you feel better; do not skip doses. · Contact your healthcare provider immediately if you experience tendon pain or swelling, numbness or tingling, or changes in mood or behavior. · Report any signs of allergic reaction such as rash, hives, or difficulty breathing. · Avoid driving or operating heavy machinery until you know how BAXDELA affects you, as it may cause dizziness or lightheadedness. · Stay well hydrated and notify your doctor if you have severe diarrhea lasting more than 2 days. · Do not use this medication if you have a history of fluoroquinolone allergy or tendon problems from other quinolones. · Inform your doctor of all medications and supplements you are taking, especially antacids, sucralfate, and multivitamins. |