Delafloxacin

BAXDELA is an antibacterial drug [see Microbiology (12.4) ] .

• BAXDELA is a fluoroquinolone antibacterial indicated for the treatment of adults with the following infections caused by designated susceptible bacteria: Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ( 1.1 ) Community-Acquired Bacterial Pneumonia (CABP) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.ICD-10: J18.9

• BAXDELA is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs, or any of the components of BAXDELA [see Warnings and Precautions (5.6) ] . Known hypersensitivity to BAXDELA or other fluoroquinolones.contraindicated

For ABSSSI and CABP: Administer BAXDELA for injection 300 mg by intravenous infusion over 60 minutes, every 12 hours, or a 450 mg BAXDELA tablet orally every 12 hours. ( 2.1 , 2.2 ) Recommended duration of treatment: ( 2.2 ) ABSSSI: 5 to 14 days CABP: 5 to 10 days Dosage for patients with renal impairment is based on the estimated glomerular filtration rate (eGFR) ( 2.3 ) Estimated Glomerular Filtration Rate (eGFR)(mL/min/1.73m 2 ) Estimate of GFR based on a Modification of Diet in Renal Disease (MDRD) equation. Recommended Dosage Regimen for BAXDELA For a total treatment duration of 5 to 14 days for the treatment of ABSSSI and 5 to 10 days for the treatment of CABP. Oral Intravenous All intravenous doses of BAXDELA are administered over 60 minutes. 30-89 No dosage adjustment No dosage adjustment 15-29 No dosage adjustment 200 mg every 12 hours End Stage Renal Disease (ESRD) (< 15 including hemodialysis) Not Recommended Not recommended due to insufficient information to provide dosing recommendations. 2.1 Important Administration Instructions BAXDELA Tablets Administer BAXDELA at least 2 hours before or 6 hours after antacids containing magnesium, or aluminum, with sucralfate, with metal cations such as iron, or with multivitamin preparations containing zinc or iron, or with didanosine buffered tablets for oral suspension or the pediatric powder for oral solution [see Drug Interactions (7.1) ] . BAXDELA Tablets can be taken with or without food [see Clinical Pharmacology (12.3) ] .

Hypersensitivity Reactions: May occur after first or subsequent doses of BAXDELA. Discontinue BAXDELA at the first sign of a skin rash or any other sign of hypersensitivity. ( 5.6 ) Clostridium difficile -associated diarrhea: Evaluate if diarrhea occurs. ( 5.7 ) 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy and Central Nervous System Effects Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions could occur within hours to weeks after starting a fluoroquinolone. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions (5.2 , 5.3 and 5.4) ] . Discontinue BAXDELA immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including BAXDELA, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones. 5.2 Tendinitis and Tendon Rupture Fluoroquinolones have been associated with an increased risk of tendinitis and tendon rupture in all ages.

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions (5.1) ] Tendinitis and Tendon Rupture [see Warnings and Precautions (5.2) ] Peripheral Neuropathy [see Warnings and Precautions (5.3) ] Central Nervous System Effects [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.7) ] Blood Glucose Disturbances [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥ 2%) are nausea, diarrhea, headache, transaminase elevations, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Melinta Therapeutics at 1-844-633-6568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of BAXDELA cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Overview of the Safety Evaluation of BAXDELA BAXDELA was evaluated in three Phase 3 multicenter, multinational, randomized, double-blind clinical trials. These trials included two trials in ABSSSI patients (Trial 1 and Trial 2) and one trial in CABP (Trial 3).

Renal Impairment: Closely monitor serum creatinine levels in patients with severe renal impairment (eGFR 15-29 mL/min/1.73 m 2 ) receiving intravenous delafloxacin. If serum creatinine level increases occur, consider changing to oral delafloxacin. Discontinue BAXDELA if eGFR decreases to < 15 mL/min/1.73 m 2 ( 8.6 ). 8.1 Pregnancy Risk Summary The limited available data with BAXDELA use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriages. When delafloxacin (as the N-methyl glucamine salt) was administered orally to rats during the period of organogenesis, no malformations or fetal death were observed at up to 7 times the estimated clinical exposure based on AUC. When rats were dosed intravenously in late pregnancy and through lactation, there were no adverse effects on offspring at exposures approximating the clinical intravenous (IV) exposure based on AUC [see Data ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Metabolism

The pharmacokinetic parameters of delafloxacin following single- and multiple-dose (every 12 hours) oral (450 mg) and intravenous (300 mg) administration are shown in Table 6. Steady-state was achieved within approximately three days with accumulation of approximately 10% and 36% following IV and oral administration, respectively.

Treatment of overdose with BAXDELA should consist of observation and general supportive measures. Hemodialysis removed about 19% of delafloxacin and 56% of SBECD (Sulfobutylether β cyclodextrin) after intravenous administration of BAXDELA [see Clinical Pharmacology (12.3) ].

• Jun 19, 2017NDANDA208610Melinta
• Jun 19, 2017NDANDA208611Melinta

1. 1Diarrhoea7632%
2. 2Off Label Use2812%
3. 3Nausea197.9%
4. 4Decreased Appetite145.8%
5. 5Rash135.4%
6. 6Malaise125.0%
7. 7Arthralgia104.2%
8. 8Drug Effective For Unapproved Indication104.2%
9. 9Product Use In Unapproved Indication104.2%
10. 10Tremor104.2%
11. 11Hypertension93.8%
12. 12Pallor93.8%
13. 13Presyncope93.8%
14. 14Autonomic Nervous System Imbalance83.3%
15. 15Drug Ineffective72.9%

The 10 most recently updated of 14 ClinicalTrials.gov registrations naming Delafloxacin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections.
  Not yet recruiting · Observational · 20 enrolled · IRCCS San Raffaele
  NCT07426471updated 2026-02-23
• Pathogenicity Factors of Staphylococcus Pettenkoferi in Foot Wounds and Osteitis in Diabetic Patients
  Active not recruiting · Observational · 230 enrolled · Centre Hospitalier Universitaire de Nīmes
  NCT06688084updated 2025-11-17
• A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults
  Terminated · Phase 1 · Interventional · 16 enrolled · Melinta Therapeutics, Inc.
  NCT06612255updated 2025-09-26
• Comparing Oral Versus Parenteral Antimicrobial Therapy
  Terminated · Phase 4 · Interventional · 94 enrolled · West Virginia University
  NCT05977868updated 2025-08-26
• Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
  Terminated · Phase 3 · Interventional · 268 enrolled · Menarini Group
  NCT04042077updated 2022-02-02
• Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia
  Completed · Phase 3 · Interventional · 860 enrolled · Melinta Therapeutics, Inc.
  NCT02679573updated 2020-02-27
• A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
  Completed · Phase 2 · Interventional · 256 enrolled · Melinta Therapeutics, Inc.
  NCT01283581updated 2019-10-16
• Evaluate Safety and Pharmacokinetic To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults
  Completed · Phase 1 · Interventional · 30 enrolled · Melinta Therapeutics, Inc.
  NCT03534622updated 2018-08-15
• Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
  Terminated · Phase 3 · Interventional · 460 enrolled · Melinta Therapeutics, Inc.
  NCT02015637updated 2018-06-20
• Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
  Completed · Phase 3 · Interventional · 850 enrolled · Melinta Therapeutics, Inc.
  NCT01984684updated 2017-11-17

Frequently asked questions

How does Delafloxacin work?

BAXDELA is an antibacterial drug [see Microbiology (12.4) ] .

What is Delafloxacin used for?

According to FDA labeling, Delafloxacin carries indications including: BAXDELA is a fluoroquinolone antibacterial indicated for the treatment of adults with the following infections caused by designated susceptible bacteria: Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ( 1.1 ) Community-Acquired Bacterial Pneumonia (CABP) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Delafloxacin?

Delafloxacin is classified as Fluoroquinolones, Fluoroquinolone Antibacterial.

What are the brand names for Delafloxacin?

Delafloxacin is marketed under brand names including Baxdela.

What are the contraindications for Delafloxacin?

Delafloxacin labeling lists contraindications including: BAXDELA is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs, or any of the components of BAXDELA [see Warnings and Precautions (5.6) ] . Known hypersensitivity to BAXDELA or other fluoroquinolones.. Always consult the full prescribing information and a clinician.