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Delafloxacin: Drug information

Delafloxacin: Drug information
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For additional information see "Delafloxacin: Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Serious adverse reactions:

Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinopathy and tendon rupture, peripheral neuropathy, and CNS effects.

Discontinue delafloxacin immediately and avoid the use of fluoroquinolones in patients who experience any of these serious adverse reactions.

Exacerbation of myasthenia gravis:

Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid delafloxacin in patients with known history of myasthenia gravis.

Brand Names: US
  • Baxdela
Pharmacologic Category
  • Antibiotic, Fluoroquinolone
Dosing: Adult
Pneumonia, community acquired, outpatients with comorbidities or inpatients

Pneumonia, community acquired, outpatients with comorbidities or inpatients (alternative agent):

Note: Clinical experience is limited; some experts reserve for patients who cannot take other agents (Ref).

Oral: 450 mg every 12 hours.

IV: 300 mg every 12 hours.

Duration of therapy: Duration is a minimum of 5 days; patients should be clinically stable with normal vital signs before therapy is discontinued (Ref).

Skin and skin structure infection

Skin and skin structure infection:

Oral: 450 mg every 12 hours for 5 to 14 days.

IV: 300 mg every 12 hours for 5 to 14 days.

Missed dose: If ≥8 hours prior to next dose, missed dose should be taken as soon as possible. If <8 hours before next dose, wait until next scheduled dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Oral, IV:

Estimated glomerular filtration rate (eGFR) 30 to 89 mL/minute/1.73 m2: No dosage adjustment necessary.

eGFR 15 to 29 mL/minute/1.73 m2:

Oral: No dosage adjustment necessary.

IV: 200 mg every 12 hours

eGFR <15 mL/minute/1.73 m2: Use is not recommended.

ESRD on hemodialysis: Use is not recommended.

Dosing: Liver Impairment: Adult

No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Cardiovascular: Bradycardia (<2%), flushing (<2%), hypertension (<2%), hypotension (<2%), palpitations (<2%), presyncope (<2%), sinus tachycardia (<2%), syncope (<2%), ventricular premature contractions (<2%)

Dermatologic: Dermatitis (<2%), pruritus (<2%), skin rash (<2%), urticaria (<2%)

Endocrine & metabolic: Hyperglycemia (<2%), hypoglycemia (<2%)

Gastrointestinal: Abdominal pain (<2%), Clostridioides difficile associated diarrhea (<2%), diarrhea (5% to 8%), dysgeusia (<2%), dyspepsia (<2%), nausea (8%), oral candidiasis (<2%), vomiting (2%)

Genitourinary: Vulvovaginal candidiasis (<2%)

Hematologic & oncologic: Agranulocytosis (<2%), anemia (<2%), leukopenia (<2%), neutropenia (<2%), pancytopenia (<2%)

Hepatic: Increased serum alkaline phosphatase (<2%), increased serum transaminases (3% to 5%)

Hypersensitivity: Hypersensitivity reaction (<2%)

Infection: Fungal infection (<2%)

Nervous system: Abnormal dreams (<2%), agitation (<2%), anxiety (<2%), confusion (<2%), dizziness (<2%), headache (3%), hypoesthesia (<2%), insomnia (<2%), paresthesia (<2%), vertigo (<2%)

Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (<2%), myalgia (<2%)

Ophthalmic: Blurred vision (<2%)

Otic: Tinnitus (<2%), vestibular disturbance (<2%)

Renal: Increased serum creatinine (<2%), renal failure syndrome (<2%), renal insufficiency (<2%)

Miscellaneous: Infusion related reaction (<2%)

Frequency not defined:

Nervous system: Central nervous system disease, exacerbation of myasthenia gravis, peripheral neuropathy

Neuromuscular & skeletal: Rupture of tendon, tendinopathy

Postmarketing: Hepatic: Hepatotoxicity (Chalasani 2021)

Contraindications

Hypersensitivity to delafloxacin, other fluoroquinolones, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Aortic aneurysm and dissection: Fluoroquinolones have been associated with aortic aneurysm ruptures or dissection within 2 months following use, particularly in elderly patients. Fluoroquinolones should not be used in patients with a known history of aortic aneurysm or those at increased risk, including patients with peripheral atherosclerotic vascular diseases, hypertension, genetic disorders involving blood vessel changes (eg, Marfan syndrome, Ehlers-Danlos syndrome), and elderly patients, unless no other treatment options are available. Longer treatment duration (eg, >14 days) may increase risk (Lee 2018).

• Glucose regulation: Fluoroquinolones have been associated with disturbances in glucose regulation, including hyperglycemia and hypoglycemia. These events have occurred most often in patients receiving concomitant oral hypoglycemic agents or insulin. Severe cases of hypoglycemia, including coma and death, have been reported. Diabetic patients should be monitored closely for signs/symptoms of disordered glucose regulation. Discontinue if a hypoglycemic reaction occurs and immediately initiate appropriate therapy.

• Hypersensitivity reactions: Severe and sometimes fatal hypersensitivity reactions, including anaphylaxis, have occurred with fluoroquinolone therapy. May occur after first or subsequent doses, and may be accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and pruritus. Discontinue therapy at the first sign of skin rash or any other sign of a hypersensitivity reaction.

• Serious adverse reactions: [US Boxed Warning]: Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions that may occur together, including tendinopathy and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue delafloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Patients of any age or without preexisting risk factors have experienced these reactions; may occur within hours to weeks after initiation.

- CNS effects: Fluoroquinolones have been associated with an increased risk of CNS effects including seizures, increased intracranial pressure (including pseudotumor cerebri), dizziness, and tremors. May occur following the first dose; discontinue immediately and avoid further use of fluoroquinolones in patients who experience these reactions. Use with caution in patients with known or suspected CNS disorder, or risk factors that may predispose to seizures or lower the seizure threshold.

- Peripheral neuropathy: Fluoroquinolones have been associated with an increased risk of peripheral neuropathy; may occur soon after initiation of therapy and may be irreversible; discontinue if symptoms of sensory or sensorimotor neuropathy occur. Avoid use in patients who have previously experienced peripheral neuropathy.

- Psychiatric reactions: Fluoroquinolones have been associated with an increased risk of psychiatric reactions, including toxic psychosis, hallucinations, or paranoia; may also cause nervousness, agitation, delirium, attention disturbances, insomnia, anxiety, nightmares, memory impairment, confusion, depression, and suicidal thoughts or actions. Use with caution in patients with a history of or risk factor for depression. Reactions may occur following the first dose; discontinue if reaction occurs and institute appropriate therapy.

- Tendinopathy/Tendon rupture: Fluoroquinolones have been associated with an increased risk of tendinopathy and tendon rupture in all ages; risk may be increased with concurrent corticosteroids, solid organ transplant recipients, and in patients >60 years of age, but has also occurred in patients without these risk factors. Rupture of the Achilles tendon has been reported most frequently; but other tendon sites (eg, rotator cuff, biceps, hand) have also been reported. Inflammation and rupture may occur bilaterally. Cases have been reported within hours or days of initiation, and up to several months after discontinuation of therapy. Strenuous physical activity, renal failure, and previous tendon disorders may be independent risk factor for tendon rupture. Discontinue at first sign of tendon pain, swelling, inflammation, or rupture. Avoid use in patients with a history of tendon disorders or who have experienced tendinopathy or tendon rupture.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to myasthenia gravis; avoid use in patients with known history of myasthenia gravis. Cases of severe exacerbations, including the need for ventilatory support, and deaths have been reported.

• Renal impairment: Use with caution and reduce dose in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/minute/1.73 m2). Use is not recommended in patients with end-stage renal disease (eGFR <15 mL/minute/1.73 m2). See also “Dosage form specific issues: Injection”.

Special populations:

• Older adult: Adverse effects (eg, tendon rupture) may be increased in elderly patients.

• G6PD deficiency: Hemolytic reactions may (rarely) occur with fluoroquinolone use in patients with G6PD deficiency (Luzzatto 2020).

Dosage form specific issues:

• Injection: Avoid use of IV formulation in patients with end-stage renal disease (eGFR <15 mL/minute/1.73 m2); injection contains excipient cyclodextrin (sulfobutylether-beta-cyclodextrin [SBECD]), which may accumulate. Closely monitor serum creatinine levels in patients with severe renal impairment (eGFR 15 to 29 mL/minute/1.73 m2) and consider using oral delafloxacin in these patients if serum creatinine levels increase; discontinue use if eGFR decreases to <15 mL/minute/1.73 m2.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Baxdela: 300 mg (1 ea) [contains edetate (edta) disodium]

Tablet, Oral:

Baxdela: 450 mg

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Baxdela Intravenous)

300 mg (per each): $170.28

Tablets (Baxdela Oral)

450 mg (per each): $85.05

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: Administer with or without food. Administer at least 2 hours before or 6 hours after antacids containing magnesium or aluminum, sucralfate, metal cations (eg, iron), multivitamins containing zinc or iron, or with didanosine buffered tablets for oral suspension or pediatric powder for oral solution.

Enteral feeding tube:

The following recommendations are based upon the best available evidence and clinical expertise. Senior editorial team: Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN; Peggi A. Guenter, PhD, RN, FASPEN; Kathleen Gura, PharmD, BCNSP, FASHP, FASPEN, FPPA, FMSHP; Mark G. Klang MS, RPh, BCNSP, PhD, FASPEN; Linda Lord, NP, ACNP-BC, CNSC, FASPEN; Lucas E. Orth, PharmD, BCPPS; Russel J. Roberts, PharmD, BCCCP, FCCM.

Oral tablet:

Gastric (eg, NG, G-tube ) or post-pyloric (eg, J-tube) tubes: Consider separating delafloxacin from enteral nutrition (EN) based on patient-specific factors and institutional policy (Ref). Crush tablet(s) into a fine powder and disperse in 15 to 30 mL purified water immediately prior to administration; draw up mixture into enteral dosing syringe and administer via feeding tube (Ref).

General guidance: May consider holding EN for 1 hour prior to and 2 hours following delafloxacin administration for adequate absorption based on patient-specific factors and institutional policy (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) before administration (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) and restart EN (Ref); consider restarting EN 2 hours after delafloxacin administration to ensure adequate absorption (Ref). The interruption of enteral feeding to allow for delafloxacin administration may impact patient nutrition; adjustment of feeding rates may be necessary to meet patient’s nutritional needs (Ref).

Enteral nutrition considerations: Manufacturer’s labeling suggests delafloxacin tablets can be administered without regard to meals; however, clinical studies validating this recommendation for EN are lacking. Studies evaluating absorption of other fluoroquinolones when administered with EN have mixed results; while studies in healthy volunteers suggest separation of EN and fluoroquinolones is not necessary, other studies suggest absorption can be variable, particularly in certain patient populations (eg, critically ill). Patient-specific parameters (eg, illness severity, post abdominal surgery, composition of feeds) and institutional policies should be considered when determining how to time administration (Ref).

Note: Recommendations may not account for differences in inactive ingredients, osmolality, or other formulation properties that may vary among products from different manufacturers.

IV: Administer by IV infusion over 60 minutes. Do not administer with any solution containing multivalent cations (eg, calcium and magnesium) through the same IV line. Do not co-infuse with other medications.

If a common IV line is being used to administer other drugs in addition to delafloxacin, the line should be flushed before and after each infusion with NS or D5W.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product and as follows, must be dispensed with this medication:

Baxdela: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208611s007lbl.pdf#page=28

Use: Labeled Indications

Pneumonia, community-acquired: Treatment of adults with community-acquired bacterial pneumonia caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

Skin and skin structure infection: Treatment of acute bacterial skin and skin structure infection caused by susceptible isolates of S. aureus (including methicillin-resistant and methicillin-susceptible isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, Enterococcus faecalis, E. coli, Enterobacter cloacae, K. pneumoniae, and P. aeruginosa.

Metabolism/Transport Effects

Substrate of BCRP, P-glycoprotein (Minor), UGT1A1, UGT1A3, UGT2B15; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Agents with Blood Glucose Lowering Effects: Quinolones may increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Quinolones may decrease therapeutic effects of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor

Amphetamines: May increase cardiotoxic effects of Quinolones. Risk C: Monitor

Antacids: May decrease absorption of Quinolones. Of concern only with oral administration of quinolones. Management: Avoid concurrent administration of quinolones and antacids to minimize the impact of this interaction. Recommendations for optimal dose separation vary by specific quinolone; see full monograph for details. Risk D: Consider Therapy Modification

Atazanavir: May increase serum concentration of UGT1A1 Substrates. Management: Do not use UGT1A1 substrates for which small increases in exposure can cause serious adverse effects together with atazanavir, and use caution with any UGT1A1 substrate, even when small changes in exposure are less likely to cause serious adverse effects. Risk D: Consider Therapy Modification

Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification

BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid

BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor

Belumosudil: May increase serum concentration of UGT1A1 Substrates. Management: Avoid coadministration of belumosudil with substrates of UGT1A1 for which minimal concentration increases can cause serious adverse effects. If coadministration is required, dose reductions of the UGT1A1 substrate may be required. Risk D: Consider Therapy Modification

Calcium Salts: May decrease absorption of Quinolones. Of concern only with oral administration of both agents. Management: Consider administering an oral quinolone at least 2 hours before or 6 hours after the dose of oral calcium to minimize this interaction. Monitor for decreased therapeutic effects of quinolones during coadministration. Risk D: Consider Therapy Modification

Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid

Corticosteroids (Systemic): May increase adverse/toxic effects of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor

Delamanid: Quinolones may increase QTc-prolonging effects of Delamanid. Management: Avoid concomitant use if possible. If coadministration is unavoidable, frequent monitoring of electrocardiograms (ECGs) throughout the full delamanid treatment period should occur. Risk D: Consider Therapy Modification

Didanosine: Quinolones may decrease serum concentration of Didanosine. Didanosine may decrease serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after didanosine. Monitor for decreased therapeutic effects of quinolones, particularly if doses cannot be separated as recommended. This does not apply to unbuffered enteric coated didanosine. Risk D: Consider Therapy Modification

Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Iron Preparations: May decrease serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, oflox-, peflox, or nalidixic acid) oral iron. Risk D: Consider Therapy Modification

Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor

Lanthanum: May decrease serum concentration of Quinolones. Management: Administer oral quinolone antibiotics at least one hour before or four hours after lanthanum. Risk D: Consider Therapy Modification

Magnesium Salts: May decrease serum concentration of Quinolones. Management: Administer oral quinolones several hours before (4 h for moxi/pe/spar/enox-, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome/pe/enox-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral magnesium salts. Risk D: Consider Therapy Modification

Methylphenidate: May increase cardiotoxic effects of Quinolones. Risk C: Monitor

Mitapivat: May decrease serum concentration of UGT1A1 Substrates. Risk C: Monitor

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease serum concentration of Quinolones. Specifically, polyvalent cations in multivitamin products may decrease the absorption of orally administered quinolone antibiotics. Management: Administer oral quinolones at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (ie, calcium, iron, magnesium, selenium, zinc). Monitor for decreased quinolone efficacy. Risk D: Consider Therapy Modification

Multivitamins/Minerals (with AE, No Iron): May decrease serum concentration of Quinolones. Specifically, minerals in the multivitamin/mineral product may impair absorption of quinolone antibiotics. Management: Administer oral quinolones at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (ie, calcium, iron, magnesium, selenium, zinc). Monitor for decreased therapeutic effects of quinolones. Risk D: Consider Therapy Modification

Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor

Nadifloxacin: May increase adverse/toxic effects of Quinolones. Risk X: Avoid

Nonsteroidal Anti-Inflammatory Agents: May increase neuroexcitatory and/or seizure-potentiating effects of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase serum concentration of Quinolones. Risk C: Monitor

Polyethylene Glycol-Electrolyte Solution: May decrease absorption of Quinolones. Management: Give oral quinolones at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider Therapy Modification

Probenecid: May increase serum concentration of Quinolones. Probenecid may decrease excretion of Quinolones. Specifically, probenecid may decreased the renal excretion of quinolone antibiotics. Risk C: Monitor

Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification

Strontium Ranelate: May decrease serum concentration of Quinolones. Management: In order to minimize any potential impact of strontium ranelate on quinolone antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during quinolone therapy. Risk X: Avoid

Sucralfate: May decrease serum concentration of Quinolones. Management: Avoid concurrent administration of quinolones and sucralfate to minimize the impact of this interaction. Recommendations for optimal dose separation vary by specific quinolone. Risk D: Consider Therapy Modification

Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification

Vitamin K Antagonists: Quinolones may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor

Zinc Salts: May decrease serum concentration of Quinolones. Management: Give oral quinolones at several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, pe- or ofloxacin or nalidixic acid) oral zinc salts. Risk D: Consider Therapy Modification

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies.

Breastfeeding Considerations

It is not known if delafloxacin is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

WBC, signs of infection, serum creatinine; signs and symptoms of disordered glucose regulation

Mechanism of Action

Delafloxacin inhibits DNA gyrase (topoisomerase II) and topoisomerase IV enzymes, which are required for bacterial DNA replication, transcription, repair, and recombination.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: 30 to 48 L

Protein binding: ~84%, primarily albumin

Metabolism: Glucuronidation by UGT1A1, UGT1A3, and UGT2B15.

Bioavailability: Oral: 58.8%

Half-life elimination: IV: 3.7 hours (single dose); Oral: 4.2 to 8.5 hours (multiple dose)

Time to peak: ~1 hour

Excretion: IV: Urine (65% as unchanged drug); Feces (28% as unchanged drug); Oral: Urine (50% as unchanged drug); Feces (48% as unchanged drug)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Mean total exposure (AUCt) was 1.3, 1.6, 1.8, 2.1, and 2.6-fold higher in subjects with mild impairment (eGFR 51 to 80 mL/minute/1.73 m2), moderate impairment (eGFR 31 to 50 mL/minute/1.73 m2), severe impairment (eGFR 15 to 29 mL/minute/1.73 m2), or end-stage renal disease on hemodialysis, respectively, compared to normal subjects following a single IV dose. Mean AUCt was 1.5-fold higher in subjects with moderate (eGFR 31 to 50 mL/minute/1.73 m2) or severe (eGFR 15 to 29 mL/minute/1.73 m2) impairment compared to normal subjects following a single oral dose.

Anti-infective considerations:

Parameters associated with efficacy:

Concentration dependent, associated with free drug area under the curve (fAUC24)/minimum inhibitory concentration (MIC) (Thabit 2016). Note: Based on other fluoroquinolones, in critically ill patients, some experts recommend AUC24/MIC goal >125 to 250 and Cmax/MIC goal ≥12 (Abdul-Aziz 2020).

Pathogen specific:

E. coli: fAUC24/MIC: 14.5 (bacteriostatic); 26.2 (1-log10 kill) (Cho 2018).

K. pneumoniae: fAUC24/MIC: 1.4 to 155 (bacteriostatic); 5.47 to 321 (1-log10 kill) (Lepak 2016; Thabit 2016; Zhao 2019).

P. aeruginosa: fAUC24/MIC: 3.41 to 24.8 (bacteriostatic); 9.82 to 51.6 (1-log10 kill) (Zhao 2019).

S. aureus (methicillin-sensitive S. aureus): fAUC24/MIC 0.4 to 3.12 (bacteriostatic); 0.4 to 10.8 (1-log10 kill) (Lepak 2016; Thabit 2016).

S. aureus (methicillin-resistant S. aureus): fAUC24/MIC: <1.05 to 8.1 (bacteriostatic); 6.61 to 24.7 (1-log10 kill) (Lepak 2016; Thabit 2016).

S. pneumoniae: fAUC24/MIC: <0.26 to 7.1 (bacteriostatic); 0.39 to 31.8 (1-log10 kill) (Lepak 2016; Thabit 2016).

Expected drug exposure in adults with normal renal function:

AUC24:

300 mg every 12 hours (steady state): IV: 46.8 mg•hour/L.

450 mg twice daily (steady state): Oral: 61.6 mg•hour/L.

Cmax (peak):

300 mg every 12 hours (steady state): IV: 9.29 mg/L.

450 mg twice daily (steady state): Oral: 7.45 mg/L.

Postantibiotic effect: Bacterial killing continues after drug concentration falls below the MIC of targeted pathogen and varies based on the organism. No data are available for delafloxacin specifically; however, for other fluoroquinolones, the postantibiotic effect is generally 1 to 3 hours (Boswell 1999; Craig 1991; Fu 1992; Fuursted 1987; Houston 1994; Kumar 1992; Licata 1997; Spangler 1998).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Baxdela;
  • (AR) Argentina: Delabaxi;
  • (AT) Austria: Quofenix;
  • (BD) Bangladesh: Delaflox | Delameg;
  • (BR) Brazil: Delabaxi;
  • (CH) Switzerland: Quofenix;
  • (CL) Chile: Delabaxi;
  • (EC) Ecuador: Delabaxi;
  • (ES) Spain: Quofenix;
  • (FI) Finland: Quofenix;
  • (FR) France: Quofenix;
  • (GB) United Kingdom: Quofenix;
  • (IE) Ireland: Quofenix;
  • (IT) Italy: Quofenix;
  • (JO) Jordan: Baxdela;
  • (LT) Lithuania: Quofenix;
  • (MX) Mexico: Baxfella;
  • (PE) Peru: Delabaxi;
  • (PR) Puerto Rico: Baxdela;
  • (QA) Qatar: Baxdela;
  • (SA) Saudi Arabia: Baxdela;
  • (UY) Uruguay: Delabaxi
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  4. Blaszczyk A, Brandt N, Ashley J, Tuders N, Doles H, Stefanacci RG. Crushed tablet administration for patients with dysphagia and enteral feeding: challenges and considerations. Drugs Aging. 2023;40(10):895-907. doi:10.1007/s40266-023-01056-y [PubMed 37707775]
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