Delafloxacin

Take delafloxacin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

delafloxacin comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may take delafloxacin with or without food.

If you are taking didanosine buffered tablets for oral suspension or the pediatric powder for oral suspension, sucralfate, or antacids, multivitamins, or other products containing aluminum, magnesium, iron, or zinc, take them at least 6 hours before or 2 hours after taking delafloxacin. These medicines may keep delafloxacin from working properly.

Keep using delafloxacin for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using delafloxacin too soon.

Dosing

The dose of delafloxacin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of delafloxacin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of infection:
    • Adults—450 milligrams (mg) every 12 hours for 5 to 14 days.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of delafloxacin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 8 hours until your next dose, skip the missed dose and go back to your regular dosing schedule.

If you miss a dose and it is more than 8 hours until your next dose, take it as soon as possible and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Baxdela
• Delafloxacin Meglumine

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

Distribution

30 to 48 L

Metabolism

Glucuronidation by UGT1A1, UGT1A3, and UGT2B15.

Excretion

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

Time to Peak

~1 hour

Half-Life Elimination

IV: 3.7 hours (single dose); Oral: 4.2 to 8.5 hours (multiple dose)

Protein Binding

~84%, primarily albumin

No dosage adjustment necessary.

Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis 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.

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

Concerns related to adverse effects:

• 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 tendinitis 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), and toxic psychosis; may also cause nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or actions. 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.

- Tendinitis/Tendon rupture: Fluoroquinolones have been associated with an increased risk of tendonitis 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 tendinitis 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”.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

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

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.