Delaflox IV Injection

Acute Bacterial Skin and Skin Structure Infections: Delafloxacin 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: Delafloxacin 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.

Usage: To reduce the development of drug-resistant bacteria and maintain the effectiveness of Delafloxacin and other antibacterial drugs, Delafloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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.

Delafloxacin Tablets: Administer Delafloxacin 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. Delafloxacin Tablets can be taken with or without food. If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

Delafloxacin Injection: Do NOT administer Delafloxacin for Injection with any solution containing multivalent cations, e.g., calcium and magnesium, through the same intravenous line. Do NOT co-infuse Delafloxacin for Injection with other medications. 

Acute bacterial skin and skin structure infections: 300 mg of Delafloxacin for Injection every 12 hours over 60 minutes by intravenous infusion Or 300 mg of Delafloxacin for Injection every 12 hours over 60 minutes by intravenous infusion, then switch to a 450 mg Delafloxacin tablet orally every 12 hours at the discretion of the physician Or 450 mg Delafloxacin tablet orally every 12 hours for 5 to 14 days.

Community-Acquired Bacterial Pneumonia: 300 mg of Delafloxacin for Injection every 12 hours over 60 minutes by intravenous infusion Or 300 mg of Delafloxacin for Injection every 12 hours over 60 minutes by intravenous infusion, then switch to a 450 mg Delafloxacin tablet orally every 12 hours at the discretion of the physician Or 450 mg Delafloxacin tablet orally every 12 hours for 5 to 10 days.

Fluoroquinolones form chelates with alkaline earth and transition metal cations. Oral administration of Delafloxacin with antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the pediatric powder for oral solution, may substantially interfere with the absorption of Delafloxacin, resulting in systemic concentrations considerably lower than desired. Therefore, Delafloxacin should be taken at least 2 hours before or 6 hours after these agents. There are no data concerning an interaction of intravenous Delafloxacin with oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, Delafloxacin should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line

Delafloxacin is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs, or any of the components of Delafloxacin.

Most common adverse reactions (incidence ≥2%) are nausea, diarrhea, headache, transaminase elevations, and vomiting.

Pregnancy: The limited available data with Delafloxacin 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.

Lactation: 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. Delafloxacin is excreted in the breast milk of rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Delafloxacin and any potential adverse effects on the breast-fed child from Delafloxacin or from the underlying maternal condition.

Hypersensitivity Reactions: May occur after first or subsequent doses of Delafloxacin. Discontinue Delafloxacin at the first sign of a skin rash or any other sign of hypersensitivity. Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs.

4-Quinolone preparations

Pediatric Use: Use in patients under 18 years of age is not recommended. Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

Geriatric use: Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone. This risk is further increased in patients receiving concomitant corticosteroid therapy.

Renal Impairment: Closely monitor serum creatinine levels in patients with severe renal impairment (eGFR 15 29 mL/min/1.73 m2 ) receiving intravenous delafloxacin. If serum creatinine level increases occur, consider changing to oral delafloxacin. Discontinue Delafloxacin if eGFR decreases to <15 mL/min/1.73 m2.

Hepatic Impairment: No dosage adjustment is necessary for Delafloxacin in patients with hepatic impairment

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.