Baxdela (Delafloxacin Meglumine)

• Tendinitis and tendon rupture (5.2)
• Peripheral neuropathy (5.3)
• Central nervous system effects (5.4)

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) (
  1.1 Acute Bacterial Skin and Skin Structure Infections

  BAXDELA 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 (CABP) (
  1.2 Community-Acquired Bacterial Pneumonia

  BAXDELA 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.
  )

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. (

• 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. (
  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

  Infection	Dosage and Route of Administration	Total Duration (days)
  ABSSSI	300 mg of BAXDELA for Injection every 12 hours over 60 minutes by intravenous infusion Or 300 mg of BAXDELA for Injection every 12 hours over 60 minutes by intravenous infusion, then switch to a 450 mg BAXDELA tablet orally every 12 hours at the discretion of the physician Or 450 mg BAXDELA tablet orally every 12 hours.	5 to 14
  CABP		5 to 10
  )
• Recommended duration of treatment: (
  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

  Infection	Dosage and Route of Administration	Total Duration (days)
  ABSSSI	300 mg of BAXDELA for Injection every 12 hours over 60 minutes by intravenous infusion Or 300 mg of BAXDELA for Injection every 12 hours over 60 minutes by intravenous infusion, then switch to a 450 mg BAXDELA tablet orally every 12 hours at the discretion of the physician Or 450 mg BAXDELA tablet orally every 12 hours.	5 to 14
  CABP		5 to 10
  )
  • 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) (
  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

  Estimated Glomerular Filtration Rate (eGFR) (mL/min/1.73 m2)As calculated using the MDRD eGFR equation as follows: eGFR (mL/min/1.73m2) = 175 × (serum creatinine)-1.154× (age)-0.203× (0.742 if female) × (1.212 if African American).	Recommended Dosage RegimenFor 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.
  	BAXDELA Tablets	BAXDELA for InjectionAll doses of BAXDELA are administered by intravenous infusion over 60 minutes.
  30-89	No dosage adjustment	No dosage adjustment
  15-29	No dosage adjustment	200 mg every 12 hours Or 200 mg every 12 hours, then switch to a 450 mg BAXDELA tablet orally every 12 hours at the discretion of the physician
  End Stage Renal Disease (ESRD) (< 15), including patients on hemodialysis (HD)	Not RecommendedNot recommended due to insufficient information to provide dosing recommendations.
  )

• For Injection: 300 mg of delafloxacin (equivalent to 433 mg delafloxacin meglumine) as a lyophilized powder in a single dose vial for reconstitution and further dilution before intravenous infusion. (
  3 DOSAGE FORMS AND STRENGTHS

  • For Injection: 300 mg of delafloxacin (equivalent to 433 mg delafloxacin meglumine) as a lyophilized powder in a single dose vial for reconstitution and further dilution before intravenous infusion.
  • Oral Tablets: 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine).

  BAXDELA for Injection

  : A sterile, lyophilized powder containing 300 mg delafloxacin (equivalent to 433 mg delafloxacin meglumine) in a single-dose vial, which must be reconstituted and further diluted prior to intravenous infusion. The lyophilized powder is a light yellow to tan cake, which may exhibit cracking and shrinkage and slight variation in texture and color.

  BAXDELA Tablets

  : Modified capsule shaped tablets in beige to mottled beige color with RX3341 debossed on one side containing 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine).
  )
• Oral Tablets: 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine). (
  3 DOSAGE FORMS AND STRENGTHS

  • For Injection: 300 mg of delafloxacin (equivalent to 433 mg delafloxacin meglumine) as a lyophilized powder in a single dose vial for reconstitution and further dilution before intravenous infusion.
  • Oral Tablets: 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine).

  BAXDELA for Injection

  : A sterile, lyophilized powder containing 300 mg delafloxacin (equivalent to 433 mg delafloxacin meglumine) in a single-dose vial, which must be reconstituted and further diluted prior to intravenous infusion. The lyophilized powder is a light yellow to tan cake, which may exhibit cracking and shrinkage and slight variation in texture and color.

  BAXDELA Tablets

  : Modified capsule shaped tablets in beige to mottled beige color with RX3341 debossed on one side containing 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine).
  )

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 BAXDELA if eGFR decreases to < 15 mL/min/1.73 m² (