Delafloxacin (Baxdela) is an anionic fluoroquinolone antibiotic that is used in the treatment of skin and soft tissue infections. It has good gram-positive and gram-negative activity.

Delafloxacin (Baxdela) Uses:

• Skin and skin structure infections:
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of:
    • Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates),
    • Staphylococcus haemolyticus,
    • Staphylococcus lugdunensis,
    • Streptococcus agalactiae,
    • Streptococcus anginosus group (including Streptococcus anginosus,
    • Streptococcus intermedius, and Streptococcus constellatus),
    • Streptococcus pyogenes,
    • Enterococcus faecalis,
    • Escherichia coli,
    • Enterobacter cloacae,
    • Klebsiella pneumoniae, and
    • Pseudomonas aeruginosa.

Delafloxacin (Baxdela) Dose in  Adults

Delafloxacin (Baxdela) Dose in the treatment of Skin and skin structure infections:

• 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 earlier to the next dose, the missed dose should be taken as early as possible. If <8 hours before the next dose, wait until the next scheduled dose.

Use in Children:

Not indicated.   

Pregnancy Risk Category: C

• Some adverse events were seen in animal reproduction studies.

Delafloxacin use during breastfeeding:

• It is not known if breast milk contains delafloxacin.
• The manufacturer advises weighing the benefits to the mother, the dangers to the baby, and the risks to the mother while deciding whether to breastfeed during treatment.

Delafloxacin (Baxdela) Dose in Kidney disease:

• Oral, IV:
  • Estimated glomerular filtration rate (eGFR) 30 to 89 mL/minute/1.73 m²:
    • Dosage adjustment not required. 
• eGFR 15 to 29 mL/minute/1.73 m²:
  • Oral: Dosage adjustment not required. 
  • IV: 200 mg every 12 hours
• eGFR <15 mL/minute/1.73 m²:
  • Not recommended.
• ESRD on hemodialysis:
  • Not recommended.

Dose in Liver disease:

No dosage adjustment is necessary.   

Side Effects of  Delafloxacin (Baxdela):

• Cardiovascular:
  • Bradycardia
  • Edema
  • Flushing
  • Hypertension
  • Hypotension
  • Localized Phlebitis
  • Palpitations
  • Phlebitis
  • Presyncope
  • Sinus Tachycardia
  • Syncope
  • Thrombosis
• Central Nervous System:
  • Headache
  • Abnormal Dreams
  • Anxiety
  • Dizziness
  • Hypoesthesia
  • Insomnia
  • Local Discomfort
  • Paresthesia
  • Vertigo
• Dermatologic:
  • Dermatitis
  • Localized Erythema
  • Extravasation Reactions
  • Pruritus
  • Skin Rash
  • Urticaria
• Endocrine & Metabolic:
  • Hyperglycemia
  • Hypoglycemia
• Gastrointestinal:
  • Diarrhea
  • Nausea
  • Abdominal Pain
  • Clostridioides Difficile
  • Dysgeusia
  • Dyspepsia
  • Oral Candidiasis
  • Vomiting
• Genitourinary:
  • Vulvovaginal Candidiasis
• Hepatic:
  • Increased Serum Transaminases
  • Increased Serum Alkaline Phosphatase
• Hypersensitivity:
  • Hypersensitivity Reaction
• Infection:
  • Fungal Infection
• Local:
  • Infusion Site Irritation
  • Infusion Site Reaction
  • Local Pain
  • Local Swelling
• Neuromuscular & Skeletal:
  • Increased Creatine Phosphokinase
  • Myalgia
• Ophthalmic:
  • Blurred Vision
• Otic:
  • Tinnitus
• Renal:
  • Increased Serum Creatinine
  • Renal Failure
  • Renal Insufficiency

Contraindications to  Delafloxacin (Baxdela):

• Hypersensitivity to delafloxacin or other fluoroquinolones or any component of this formulation

Warnings and precautions

• Regulation of Glucose
  • Fluoroquinolones have been linked to abnormalities in the control of glucose. Hypo- and hyperglycemia are two of these. Treatment with fluoroquinolones has been linked to serious, occasionally fatal hypersensitivity responses.
  • Patients who receive insulin or oral hypoglycemic drugs concurrently are most likely to experience these events.
  • Reports have come in of severe hypoglycemia - which can lead to coma or death - cases.
  • Diabetic patients need to be closely monitored for signs/symptoms that may indicate disordered glucose regulation.
  • Stop using the medication if you experience hypoglycemic reactions. Get immediate treatment.
• Hypersensitivity reactions
  • For patients who have suffered any of these serious side events, cease taking delafloxacin right away, and stop using fluoroquinolones.
  • It can occur following first or subsequent doses.
  • The first sign of hypersensitivity reactions, such as skin rash, is the time to stop therapy.
• Warning: Serious adverse reactions
  • Fluoroquinolones can cause severe and possibly irreversible adverse reactions. These include tendon rupture, tendon underpin, peripheral neuropathy and CNS effects.
  • Fluoroquinolones have been associated with a higher incidence of CNS side effects, including tremors, disorientation, and elevated intracranial pressure (including pseudotumor cerebri).
  • These reactions can occur in patients of all ages and without any preexisting risk factors.
• CNS effects
  • Fluoroquinolones have been associated with a higher incidence of CNS side effects, including tremors, disorientation, and elevated intracranial pressure (including pseudotumor cerebri).
  • This reaction may occur after the first dose. If you experience this, discontinue using fluoroquinolones immediately.
  • Patients with a CNS disorder or other risk factors, such as a known or suspected CNS disorder or a seizure threshold lower or predisposing factors, should be cautious.
• Peripheral neuropathy:
  • Peripheral neuropathy risk has been connected to the use of fluoroquinolones.
  • After therapy starts, it may happen rapidly and may not go away. Stop taking them if sensorimotor or sensory neuropathy symptoms appear.
  • Patients who have had peripheral neuropathy in the past should not be used.
• Psychiatric reactions
  • Fluoroquinolones have been associated with a higher incidence of psychiatric side effects.
  • Hallucinations, toxic psychosis, and paranoia are a few of these. Additionally, it may result in jitters, anxiety, nightmares, or memory loss.
  • Patients with depression history or other risk factors should be cautious.
  • After the first dose, reactions may occur. If this happens, discontinue use and seek appropriate treatment.
• Tendinitis and Tendon rupture
  • All ages of people have experienced tendinitis and tendon rupture after using fluoroquinolones.
  • Patients over 60, those undergoing solid organ transplants, those receiving concurrent corticosteroid therapy, and patients receiving solid organ transplants are at a higher risk.
  • However, patients without these risk factors have also experienced it.
  • Achilles tendon rupture has been seen most frequently.
  • Hand, biceps, and rotator cuff have all been mentioned.
  • Bilateral inflammation or rupture are both possible.
  • Patients have reported cases within hours or days of the start of their therapy as well as for several months after stopping it.
  • Tendon rupture can also be caused by strenuous activity, kidney failure, or previous tendon disorders.
  • Stop using it immediately if you feel tendon pain, swelling or inflammation.
  • Patients with tendon disorders, tendinitis, or tendon rupture should not use it.
• Superinfection
  • The continued use of this drug might result in fungal or bacterial overinfections, such as pseudomembranous collitis and C. difficile-associated diarrhoea (CDAD).
  • After more than two months of receiving antibiotics, CDAD was noticed.
• Myasthenia gravis: [US Boxed Warning]:
  • Myasthenia Gravis might result in muscle weakening as a result. It shouldn't be used by people who have had myasthenia gravis in the past.
  • There have been cases of death and severe exacerbations.
• Renal impairment
  • If the estimated GFR is between 15 and 29 mL/minute/1.73m2, patients with severe renal impairment should exercise caution and the dose may be decreased.
  • It is not indicated for use by people with end-stage renal disease (eGFR 15mL/min/1.73m2).
  • Also see the "Dosage form specific issues - Injection" section.

Delafloxacin: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

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

How to administer Delafloxacin (Baxdela)?

Oral:

• Either with or without food, administer it.
• Give at least two hours before or six hours after sucralfate, iron- or magnesium-containing antacids, metal cations, multivitamins, didanosine buffered tablets for oral suspension, or child powder for oral solution.

IV:

• Give it by IV infusion over a 60-minute period.
• Using the same IV line to administer any solution containing multivalent cations (such as calcium and magnesium) is not necessary.
  Infuse it separately from other drugs.

If delafloxacin is being administered by a standard IV line along with other medications, the line needs to be flushed with NS or D5W before and after each infusion.

Mechanism of action of  Delafloxacin (Baxdela):

The topoisomerase II and topoisomerase III enzymes, which are necessary for bacterial DNA replication, repair, and recombination, are inhibited by delafloxacin.

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 doses)

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)

International Brands of Delafloxacin:

• Baxdela

Delafloxacin Brand Names in Pakistan:

No Brands are Available in Pakistan.