Indications

Acute Bacterial Skin and Skin Structure Infections: Delaflox is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: 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.

Community-Acquired Bacterial Pneumonia: Delaflox is indicated in adults for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.

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Pharmacology

Delafloxacin inhibits the activity of bacterial DNA topoisomerase IV and DNA gyrase (topoisomerase II). This interferes with bacterial DNA replication by preventing the relaxation of positive supercoils introduced as part of the elongation process. The resultant strain inhibits further elongation. Delafloxacin exerts concentration-dependent bacteriocidal activity.

The antibacterial activity of delafloxacin appears to best correlate with the ratio of area under the concentration-time curve of free delafloxacin to minimal inhibitory concentration (fAUC/MIC) for Gram-positive organisms such as Staphylococcus aureus and Gram-negative organisms such as Escherichia coli based on animal models of infection.

Dosage & Administration

Route of administration: Intravenous (IV) Injection

Hepatic Impairment: No dosage adjustment is necessary for Delaflox (Delafloxacin) in patients with hepatic impairment.

Renal Impairment: Dosage adjustment is required for patients with severe renal impairment (eGFR 15-29 mL/min/1.73m2). In patients with severe renal impairment or ESRD (eGFR of < 15 mL/min/1.73 m2), accumulation of the intravenous vehicle, sulfobutylether-β-cyclodextrin (SBECD) occurs. Serum creatinine levels should be carefully monitored in patients in such case. If serum creatinine level increases, consider switching to oral Delafloxacin. Discontinue Delafloxacin if eGFR decreases to < 15 mL/min/1.73 m2.

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Interaction

With medicine: Do not administer Delaflox for Injection with any solution containing multivalent cations (e.g. calcium and magnesium) through the same intravenous line. Do not co-infuse Delaflox for Injection with other medications. With food & others: Not applicabl

Contraindications

Delafloxacin is contraindicated in patients with known hypersensitivity to Delafloxacin or any of the fluoroquinolone class of antibacterial drugs. Discontinue Delafloxacin at the first appearance of a skin rash or any other sign of hypersensitivity

Side Effects

Common Side Effects: The most common side effects of Delaflox include nausea, diarrhea, headache, transaminase elevations and vomiting.

Pregnancy & Lactation

The limited available data with Delafloxacin use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriages. There are no data available on the presence of Delafloxacin in human milk, the effects on the breast-fed infant or the effects on milk production.

Precautions & Warnings

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy and CNS effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). Discontinue Delaflox immediately at the first signs or symptoms of any serious adverse reaction

Fluoroquinolones have been associated with an increased risk of tendinitis and tendon rupture in all ages. Tendinitis or tendon rupture can occur, within hours or days of starting a fluoroquinolone, or even several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally. Discontinue Delaflox immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon.

Fluoroquinolones have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including Delaflox. Discontinue Delaflox immediately if the patient experiences symptoms of peripheral neuropathy.

Fluoroquinolones, including Delaflox, have been associated with an increased risk of psychiatric adverse reactions. Toxic psychosis; hallucinations or paranoia; depression or suicidal thoughts or acts; delirium, disorientation, confusion or disturbances in attention; anxiety, agitation or nervousness; insomnia or nightmares; memory impairment may occur. Discontinue Delaflox immediately if the patient experiences symptoms.

Fluoroquinolones have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (including pseudotumor cerebri), dizziness and tremors. Discontinue Delaflox immediately if the patient experiences symptoms.

Fluoroquinolones have neuromuscular blocking activity and may cause muscle weakness in persons with myasthenia gravis. Avoid Delaflox in patients with known history of myasthenia gravis.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, have been reported in patients receiving fluoroquinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticarial and itching. Discontinue Delaflox at the first appearance of a skin rash or any other sign of hypersensitivity.

Clostridium difficile-associated diarrhea (CDAD) has been reported in users of nearly all systemic antibacterial drugs, including Delaflox, with severity ranging from mild diarrhea to fatal colitis.

Increased risk of aortic aneurysm and dissection have been reported within two months following use of fluoroquinolones, particularly in elderly patients.

Fluoroquinolones have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported with other fluoroquinolones. If a hypoglycemic reaction occurs, discontinue Delaflox immediately.

Delaflox can make you feel dizzy and lightheaded. Do not drive, operate machinery or do other activities that require mental alertness or coordination until you know how Delaflox affects you.

Use in Special Populations

Use in children & adolescents: It is not known if Delaflox is safe and effective in people under 18 years of age and use in people under 18 years of age is not recommended.

Geriatric use: Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone. Caution should be used when prescribing Delaflox to elderly patients especially those on corticosteroids. If any symptoms of tendinitis or tendon rupture occur, then discontinuation of Delaflox is recommended. Case of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients were reported. Caution should be used when prescribing Delaflox to elderly patients.

Overdose Effects

Treatment of overdose with Delaflox should consist of observation and general supportive measures. Hemodialysis found to remove about 19% of Delaflox and 56% of Sulfobutylether-β-cyclodextrin after IV administration of Delaflox.

Therapeutic Class

4-Quinolone preparations

Storage Conditions

Store within 20º C - 25º C (Excursions permitted to 15°C to 30°C) & dry place, protected from light. Keep all medicines out of reach of children. Reconstituted vial may be stored either refrigerated (2°C to 8°C) or at controlled room temperature (20°C to 25°C) for up to 24 hours. Do not freeze. Once diluted into the intravenous bag, Delaflox may be stored either refrigerated (2°C to 8°C) or at a controlled room temperature (20°C to 25°C) for up to 24 hours. Do not freeze.