Delafloxacin

BAXDELA is a fluoroquinolone antibacterial indicated for the treatment of adults with the following infections caused by designated susceptible bacteria: Acute Bacterial Skin and Skin Structure Infections (ABSSSI). Community-Acquired Bacterial Pneumonia (CABP). To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

BAXDELA is an antibacterial drug.

For ABSSSI and CABP: Administer BAXDELA for injection 300 mg by intravenous infusion over 60 minutes, every 12 hours, or a 450 mg BAXDELA tablet orally every 12 hours. Recommended duration of treatment: ABSSSI: 5 to 14 days CABP: 5 to 10 days Dosage for patients with renal impairment is based on the estimated glomerular filtration rate (eGFR). Estimated Glomerular Filtration Rate (eGFR)(mL/min/1.73m 2 ) Estimate of GFR based on a Modification of Diet in Renal Disease (MDRD) equation. Recommended Dosage Regimen for BAXDELA For a total treatment duration of 5 to 14 days for the treatment of ABSSSI and 5 to 10 days for the treatment of CABP.

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

Boxed warning: Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including: Tendinitis and tendon rupture. Peripheral neuropathy. Central nervous system effects. Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions. Hypersensitivity Reactions: May occur after first or subsequent doses of BAXDELA. Discontinue BAXDELA at the first sign of a skin rash or any other sign of hypersensitivity. Clostridium difficile -associated diarrhea: Evaluate if diarrhea occurs.

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions Tendinitis and Tendon Rupture Peripheral Neuropathy Central Nervous System Effects Hypersensitivity Reactions Clostridium difficile -Associated Diarrhea Blood Glucose Disturbances Most common adverse reactions (incidence ≥ 2%) are nausea, diarrhea, headache, transaminase elevations, and vomiting.

Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins Fluoroquinolones form chelates with alkaline earth and transition metal cations. Oral administration of BAXDELA 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 BAXDELA, resulting in systemic concentrations considerably lower than desired. Therefore, BAXDELA should be taken at least 2 hours before or 6 hours after these agents. There are no data concerning an interaction of intravenous BAXDELA with oral antacids, sucralfate, multivitamins, didanosine, or metal cations.

BAXDELA Tablets and BAXDELA for Injection should be stored at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze. The reconstituted powder may be stored for up to 24 hours under refrigerated or controlled room temperature and then further diluted for intravenous infusion. The reconstituted solution in the infusion bag may be stored under refrigerated or controlled room temperature conditions for up to 24 hours.