BAXDELA Tablet / Powder for solution for injection Ref.[9994] Active ingredients: Delafloxacin

2.1 Important Administration Instructions

BAXDELA Tablets

Administer BAXDELA 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 [see Drug Interactions (7.1)].

BAXDELA Tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

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.

BAXDELA for Injection

Do NOT administer BAXDELA for Injection with any solution containing multivalent cations, e.g., calcium and magnesium, through the same intravenous line [see Drug Interactions (7.1)]. Do NOT co-infuse BAXDELA for Injection with other medications [see Dosage and Administration (2.4)].

2.2 Recommended Dosage Regimen

For treatment of adults with ABSSSI or CABP, the recommended dosage regimen of BAXDELA is described in Table 1 below.

Table 1. Dosage of BAXDELA in Adult ABSSSI or CABP Patients:

2.3 Dosage in Patients with Renal Impairment

Table 2 below describes the dosage modification based on the estimated glomerular filtration rate (eGFR) that is recommended in patients with 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 receiving BAXDELA intravenously, closely monitor serum creatinine levels and eGFR [see Use in Specific Populations (8.7)]. If serum creatinine level increases, consider switching to BAXDELA Tablets. Discontinue BAXDELA if eGFR decreases to <15 mL/min/1.73 m².

Table 2. Dosage Adjustment of BAXDELA in Patients with Renal Impairment:

* As calculated using the MDRD eGFR equation as follows: eGFR (mL/min/1.73m²)
= 175 × (serum creatinine)^-1.154 × (age)^-0.203 × (0.74 2 if female) × (1.212 if African American).
^† 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 in adult patients.
^‡ All doses of BAXDELA are administered by intravenous infusion over 60 minutes.
^§ Not recommended due to insufficient information to provide dosing recommendations.

2.4 Preparation and Administration of BAXDELA for Injection Intravenous Solution

Reconstitution and Dilution

1. BAXDELA must be reconstituted and then further diluted under aseptic conditions. Reconstitute the powder in the BAXDELA vial using 10.5 mL of 5% Dextrose Injection (D5W) or 0.9% Sodium Chloride Injection for each 300 mg vial. Shake the vial vigorously until contents are completely dissolved. The reconstituted vial contains 300 mg per 12 mL (25 mg/mL) of BAXDELA as a clear yellow to amber colored solution.

2. The reconstituted solution must then be diluted to a total volume of 250 mL using either 0.9% Sodium Chloride or D5W to achieve a concentration of 1.2 mg/mL, prior to administration. Prepare the required dose for intravenous infusion by withdrawing the appropriate volume from the reconstituted vial per Table 3 below:

Table 3. Preparation of BAXDELA Doses:

3. Aseptically transfer the required volume of BAXDELA reconstituted solution from the vial to an intravenous bag to achieve a 250 mL volume of infusion solution. Discard any unused portion of the reconstituted solution.

4. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Storage of the Reconstituted and Diluted Solutions

Reconstituted vials, as described above, may be stored either refrigerated at 2°C to 8°C (36°F to 46°F), or at controlled room temperature 20°C to 25°C (68°F to 77°F) for up to 24 hours. Do not freeze.

Once diluted into the intravenous bag, as described above, BAXDELA may be stored either refrigerated at 2°C to 8°C (36°F to 46°F) or at a controlled room temperature of 20°C to 25°C (68°F to 77°F) for up to 24 hours. Do not freeze.

Administration

After reconstitution and dilution, administer BAXDELA by intravenous infusion, using a total infusion time of 60 minutes [see Dosage and Administration (2.1)].

The compatibility of reconstituted BAXDELA with intravenous medications, additives, or substances other than D5W or 0.9% Sodium Chloride Injection has not been established. If a common intravenous line is being used to administer other drugs in addition to BAXDELA the line should be flushed before and after each BAXDELA infusion with 0.9% Sodium Chloride Injection or D5W.

Treatment of overdose with BAXDELA should consist of observation and general supportive measures. Hemodialysis removed about 19% of delafloxacin and 56% of SBECD (Sulfobutylether β cyclodextrin) after intravenous administration of BAXDELA [see Clinical Pharmacology (12.3)].

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) [see USP Controlled Room Temperature].

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 [see Dosage and Administration (2.4)]. Do not freeze.