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Baxdela

DELAFLOXACIN MEGLUMINE

Manufacturer: Melinta Therapeutics, LLC

Score: 144.0

Quick Summary

Baxdela is a fluoroquinolone antibacterial drug used for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria. The drug has shown efficacy in clinical trials, but it also carries important safety information, including warnings about tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of myasthenia gravis. The recommended dosage regimen is 300 mg by intravenous infusion every 12 hours or 450 mg orally every 12 hours, with duration of treatment ranging from 5 to 14 days for ABSSSI and 5 to 10 days for CABP. Special population considerations include use in pregnancy, pediatric use, and geriatric use, with warnings about potential risks and limited data available.

Key Clinical Findings and Indications

  • Treatment of ABSSSI caused by susceptible microorganisms
  • Treatment of CABP caused by susceptible microorganisms
  • Efficacy in clinical trials for ABSSSI and CABP

Important Safety Information

Warning

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions, including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of myasthenia gravis

Contraindications

  • Known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs

Adverse Reactions

  • Nausea
  • Diarrhea
  • Headache
  • Transaminase elevations
  • Vomiting

Dosing Recommendations

General Guidance

Dosage adjustment is required for patients with severe renal impairment (eGFR 15-29 mL/min/1.73m^2)

ABSSSI

Adult Dose

300 mg by intravenous infusion every 12 hours or 450 mg orally every 12 hours

Pediatric Dose

Not recommended for use in patients under 18 years of age

CABP

Adult Dose

300 mg by intravenous infusion every 12 hours or 450 mg orally every 12 hours

Pediatric Dose

Not recommended for use in patients under 18 years of age

Special Population Considerations

Pregnancy

  • Limited data available on use in pregnant women
  • No malformations or fetal death observed in animal studies

Nursing Mothers

  • No data available on use in nursing mothers

Pediatric Use

  • Not recommended for use in patients under 18 years of age
  • Fluoroquinolones cause arthropathy in juvenile animals

Geriatric Use

  • Geriatric patients are at increased risk for developing severe tendon disorders
  • Mean Cmax and AUC∞ of delafloxacin were about 35% higher in elderly subjects compared to young adults