Baxdela

BAXDELA- delafloxacin meglumine tablet
BAXDELA- delafloxacin meglumine injection, powder, lyophilized, for solution
Melinta Therapeutics, Inc

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (5.1), including:

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

Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions (5.1)

Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid BAXDELA in patients with known history of myasthenia gravis. (5.5)

1 INDICATIONS AND USAGE

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.

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.

1.3 Usage

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 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.

2 DOSAGE AND ADMINISTRATION

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

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)* Recommended Dosage Regimen
BAXDELA Tablets BAXDELA for Injection
*
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).
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.
30-89 No dosage adjustment No dosage adjustment
15-29 No dosage adjustment 200 mg every 12 hours Or200 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 Recommended §

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