Baxdela

Name: Baxdela

Introduction

Delafloxacin meglumine is a fluoroquinolone anti-infective agent.1

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Delafloxacin Meglumine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablet

450 mg

Baxdela

Melinta

Parenteral

For Injection, for IV infusion

300 mg

Baxdela

Melinta

Commonly used brand name(s)

In the U.S.

  • Baxdela

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

Proper Use of Baxdela

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may take this medicine with or without food.

If you are taking didanosine buffered tablets for oral suspension or the pediatric powder for oral suspension, sucralfate, or antacids, multivitamins, or other products containing aluminum, magnesium, iron, or zinc, take them at least 6 hours before or 2 hours after taking delafloxacin. These medicines may keep delafloxacin from working properly.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using this medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of infection:
      • Adults—450 milligrams (mg) every 12 hours for 5 to 14 days.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 8 hours until your next dose, skip the missed dose and go back to your regular dosing schedule.

If you miss a dose and it is more than 8 hours until your next dose, take it as soon as possible and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Use in specific populations

Pregnancy

Risk Summary

The limited available data with Baxdela 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 [see Data].

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Data

Animal Data

In embryo-fetal studies, oral administration of delafloxacin to pregnant rats during the period of major organogenesis resulted in maternal toxicity and reduced fetal body weights at the highest dose (1600 mg/kg/day) and fetal ossification delays at all doses. No malformations were reported up to the highest dose tested (approximately 7 times the estimated human plasma exposure based on AUC). The lowest dose, 200 mg/kg/day (approximately 2.5 times the estimated human plasma exposure based on AUC), was still toxic to the fetus, based on ossification delays. In rabbits, a species known to be extremely sensitive to maternal toxicity of antibacterial drugs, no embryo-fetal developmental toxicity was observed up to the highest dose which induced maternal toxicity (1.6 mg/kg/day, or approximately 0.01 times the estimated human plasma exposure based on AUC). In a pre-postnatal study in rats of IV administered delafloxacin, dams at the highest dose tested (120 mg/kg/day) exhibited slightly lower body weights and slightly longer gestation length than control animals. Exposure at that dose was estimated to be approximately 5 times human plasma exposure based on AUC, as determined in a separate shorter term study at an earlier stage of pregnancy. Effects on pups at that dose included increased mortality during lactation, small stature, and lower body weights, but no changes in learning and memory, sensory function, locomotor activity, developmental landmarks, or reproductive performance were reported. The No Adverse Effect Level (NOAEL) for maternal toxicity pup development in that study was 60 mg/kg/day (approximately 580 mg/day IV for a 60 kg patient, or just below the clinical IV dose).

Lactation

Risk Summary

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 [see Data]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Baxdela and any potential adverse effects on the breast-fed child from Baxdela or from the underlying maternal condition.

Data

After single oral dose of 20 mg/kg (approximately 194 mg for a 60 kg patient) 14C labeled delafloxacin on post-natal day 11, the radioactivity was transferred into the milk of lactating rats. The mean milk/plasma radioactivity concentration ratios in dams at 4 and 8 hours after dosing were 8.5 and 4.0, respectively, and essentially background by 24 hours. The rate of elimination of radioactivity was similar in milk and plasma. Absorption of radioactive drug by rat pups following nursing was observed.

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. Pediatric studies were not conducted because risk-benefit considerations do not support the use of Baxdela for ABSSSI in this population. Fluoroquinolones cause arthropathy in juvenile animals.

Geriatric Use

Of the 754 adults patients treated with Baxdela in the Phase 3 ABSSSI trials, 111 (15%) were ≥ 65 years of age. The clinical response rates at 48-72 hours in the Baxdela group (ITT Population) in patients aged ≥ 65 years old were 75.7% and 82.3% in patients aged < 65 years old; comparator response rates were 71.3% in patients aged ≥ 65 years old and 82.1% in patients aged < 65 years old.

In the safety population, of the 741 adult patients treated with Baxdela, 110 (16.4%) patients aged ≥ 65 years old and 146 (23.1%) patients aged < 65 years old had at least one adverse drug reaction.

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolones. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Baxdela to elderly patients especially those on corticosteroids. Patients should be informed of this potential adverse reaction and advised to discontinue Baxdela and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see Warnings and Precautions (5.1)].

In elderly subjects (≥ 65 years), the mean Cmax and AUC∞ of delafloxacin were about 35% higher compared with young adults, which is not considered clinically significant [see Clinical Pharmacology (12.3)].

Hepatic Impairment

No dosage adjustment is necessary for Baxdela in patients with hepatic impairment [see Clinical Pharmacology (12.3)]

Renal Impairment

No dosage adjustment of Baxdela is necessary in patients with mild (eGFR 60-89 mL/min/1.73 m2) or moderate (eGFR 30-59 mL/min/1.73 m2) renal impairment. The dose of Baxdela intravenous IV infusion in patients with severe renal impairment (eGFR 15-29 mL/min/1.73 m2) should be decreased to 200 mg intravenously every 12 hours; the dose of oral Baxdela in patients with severe renal impairment (eGFR 15-29 mL/min/1.73 m2) is 450mg orally every 12 hours. Baxdela is not recommended in patients with End Stage Renal Disease [ESRD] (eGFR of <15 mL/min/1.73 m2) [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

In patients with severe renal impairment or ESRD (eGFR of < 15 mL/min/1.73 m2), accumulation of the intravenous vehicle, sulfobutylether-β-cyclodextrin (SBECD) occurs. Serum creatinine levels should be closely monitored in patients with severe renal impairment receiving intravenous Baxdela. If serum creatinine level increases occur, consideration should be given to changing to oral Baxdela. If eGFR decreases to <15 mL/min/1.73 m2, Baxdela should be discontinued.

Baxdela - Clinical Pharmacology

Mechanism of Action

Baxdela is an antibacterial drug [see Microbiology (12.4)].

Pharmacodynamics

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.

Cardiac Electrophysiology

In a randomized, positive- and placebo-controlled, thorough QT/QTc study, 51 healthy subjects received Baxdela 300 mg IV, Baxdela 900 mg IV, oral moxifloxacin 400 mg, or placebo. Neither Baxdela 300 mg nor Baxdela 900 mg (three times the intravenous therapeutic dose) had any clinically relevant adverse effect on cardiac repolarization.

Photosensitivity Potential

A study of photosensitizing potential to ultraviolet (UVA and UVB) and visible radiation was conducted in 52 healthy volunteers (originally 13 subjects per treatment group). Baxdela, at 200 mg/day and 400 mg/day (0.22 and 0.44 times the approved recommended daily oral dosage, respectively) for 7 days, and placebo did not demonstrate clinically significant phototoxic potential at any wavelengths tested (295 nm to 430 nm), including solar simulation. The active comparator (lomefloxacin) demonstrated a moderate degree of phototoxicity at UVA 335 nm and 365 nm and solar simulation wavelengths.

Pharmacokinetics

The pharmacokinetic parameters of delafloxacin following single- and multiple-dose (every 12 hours) oral (450 mg) and intravenous (300 mg) administration are shown in Table 4. Steady-state was achieved within approximately three days with accumulation of approximately 10% and 36% following IV and oral administration, respectively.

Table 4 Mean (SD) Delafloxacin Pharmacokinetic Parameters Following Single and Multiple Oral and Intravenous Administration
Tablet Intravenous Injection
Parameters Single Dose
450 mg
Steady State
450 mg Q12h*
Single Dose
300 mg
Steady State
300 mg Q12h*
Cmax = maximum concentration; Tmax = time to reach Cmax; AUC = area under the concentration-time curve; CL = systemic clearance; CL/F = apparent oral clearance; Rac = accumulation ratio
* Q12h is every 12 hours † Median (range) ‡ AUC is AUCτ (AUC from time 0 to 12 hours) for single dose and multiple-dose administration § CL is reported for intravenous injection. CL/F is reported for tablet
T max (h)† 0.75 (0.5, 4.0) 1.00 (0.50, 6.00) 1.0 (1.0, 1.2) 1.0 (1.0, 1.0)
Cmax (µg/mL) 7.17 (2.01) 7.45 (3.16) 8.94 (2.54) 9.29 (1.83)
AUC (µg∙h/mL)‡ 22.7 (6.21) 30.8 (11.4) 21.8 (4.54) 23.4 (6.90)
CL or CL/F(L/h)§ 20.6 (6.07) 16.8 (6.54) 14.1 (2.81) 13.8 (3.96)
CLr (L/h) - 5.89 (1.53) 6.69 (2.19)
Rac 1.36 1.1

Absorption

The absolute bioavailability for Baxdela 450 mg oral tablet administered as a single dose was 58.8%. The AUC of delafloxacin following administration of a single 450 mg oral (tablet) dose was comparable to that following a single 300 mg intravenous dose. The Cmax of delafloxacin was achieved within about 1 hour after oral administration under fasting condition. Food (kcal:917, Fat: 58.5%, Protein: 15.4%, Carbohydrate: 26.2%). did not affect the bioavailability of delafloxacin [see Dosage and Administration (2.1)].

Distribution

The steady state volume of distribution of delafloxacin is 30–48 L which approximates total body water. The plasma protein binding of delafloxacin is approximately 84%; delafloxacin primarily binds to albumin. Plasma protein binding of delafloxacin is not significantly affected by renal impairment.

Elimination

In a mass balance study, the mean half-life for delafloxacin was 3.7 hours (SD 0.7 hour) after a single dose intravenous administration. The mean half-life values for delafloxacin ranged from 4.2 to 8.5 hours following multiple oral administrations. Following administration of a single 300 mg intravenous dose of Baxdela, the mean clearance (CL) of delafloxacin was 16.3 L/h (SD 3.7 L/h), and the renal clearance (CLr) of delafloxacin accounts for 35-45% of the total clearance.

Metabolism

Glucuronidation of delafloxacin is the primary metabolic pathway with oxidative metabolism representing about 1% of an administered dose. The glucuronidation of delafloxacin is mediated mainly by UGT1A1, UGT1A3, and UGT2B15. Unchanged parent drug is the predominant component in plasma. There are no significant circulating metabolites in humans.

Excretion

After single intravenous dose of 14C-labeled delafloxacin, 65% of the radioactivity was excreted in urine as unchanged delafloxacin and glucuronide metabolites and 28% was excreted in feces as unchanged delafloxacin. Following a single oral dose of 14C-labeled delafloxacin, 50% of the radioactivity was excreted in urine as unchanged delafloxacin and glucuronide metabolites and 48% was excreted in feces as unchanged delafloxacin.

Specific Populations

Based on a population pharmacokinetic analysis, the pharmacokinetics of delafloxacin were not significantly impacted by age, sex, race, weight, body mass index, and disease state (ABSSSI).

Patients with Hepatic Impairment

No clinically meaningful changes in delafloxacin Cmax and AUC were observed, following administration of a single 300-mg intravenous dose of Baxdela to patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B, and C) compared to matched healthy control subjects.

Patients with Renal Impairment

Following a single intravenous (300 mg) administration of delafloxacin to subjects with mild (eGFR = 51-80 mL/min/1.73 m2), moderate (eGFR = 31–50 mL/min/1.73 m2), severe (eGFR = 15-29 mL/min/1.73 m2) renal impairment, and ESRD on hemodialysis receiving intravenous delafloxacin within 1 hour before and 1 hour after hemodialysis, mean total exposure (AUCt) of delafloxacin was 1.3, 1.6, 1.8, 2.1, and 2.6-fold higher, respectively than that for matched normal control subjects. The mean dialysate clearance (CLd) of delafloxacin was 4.21 L/h (SD 1.56 L/h). After about 4 hours of hemodialysis, the mean fraction of administered delafloxacin recovered in the dialysate was about 19% [see Use in Specific Populations (8.7)].

Following a single oral (400 mg) administration of delafloxacin to subjects with mild (eGFR = 51-80 mL/min/1.73 m2), moderate (eGFR = 31-50mL/min/1.73m2), or severe (eGFR = 15-29 mL/min/1.73m2) renal impairment, the mean total exposure (AUCt) of delafloxacin was about 1.5-fold higher for subjects with moderate and severe renal impairment compared with healthy subjects, whereas total systemic exposures of delafloxacin in subjects with mild renal impairment were comparable with healthy subjects.

In patients with moderate (eGFR = 31–50 mL/min/1.73 m2), or severe (eGFR = 15–29 mL/min/1.73 m2) renal impairment or ESRD on hemodialysis, accumulation of the intravenous vehicle SBECD occurs. The mean systemic exposure (AUC) increased 2-fold, 5-fold, 7.5-fold, and 27-fold for patients with moderate impairment, severe impairment, ESRD on hemodialysis receiving intravenous delafloxacin within 1 hour before, and 1 hour after hemodialysis respectively, compared to the healthy control group. In subjects with ESRD undergoing hemodialysis, SBECD is dialyzed with a clearance of 4.74 L/h. When hemodialysis occurred 1 hour after the Baxdela infusion in subjects with ESRD, the mean fraction of SBECD recovered in the dialysate was 56.1% over approximately 4 hours.

Geriatric Patients

Following single oral administration of 250 mg delafloxacin (approximately 0.6 times the approved recommended oral dose), the mean delafloxacin Cmax and AUC∞ values in elderly subjects (≥ 65 years) were about 35% higher compared to values obtained in young adults (18 to 40 years). This difference is not considered clinically relevant. A population pharmacokinetic analysis of patients with ABSSSI showed no significant impact of age on delafloxacin pharmacokinetics.

Male and Female Patients

Following single oral administration of 250 mg delafloxacin (approximately 0.6 times the approved recommended oral dose), the mean delafloxacin Cmax and AUC∞ values in male subjects were comparable to female subjects. Results from a population pharmacokinetic analysis showed that females have a 24% lower AUC than males. This difference is not considered clinically relevant.

Drug Interaction Studies

Drug Metabolizing Enzymes

Delafloxacin at clinically relevant concentrations does not inhibit the cytochrome P450 isoforms CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5 in vitro in human liver microsomes. At a delafloxacin concentration (500 µM) well above clinically relevant exposures, the activity of CYP2E1was increased.

In human hepatocytes, delafloxacin showed no potential for in vitro induction of CYP1A2, 2B6, 2C19, or 2C8 but was a mild inducer of CYP2C9 at a concentration of 100 µM and CYP3A4 at a clinically relevant concentration. Administration of Baxdela 450 mg every 12 hours for 5 days to healthy male and female subjects (n = 22) prior to and on Day 6 with a single oral 5-mg dose of midazolam (a sensitive CYP3A substrate), did not affect the Cmax and AUC values for midazolam or 1-hydroxy midazolam compared to administration of midazolam alone.

Transporters

Delafloxacin was not an inhibitor of the following hepatic and renal transporters in vitro at clinically relevant concentrations: MDR1, BCRP, OAT1, OAT3, OATP1B1, OATP1B3, BSEP, OCT1 and OCT2. Delafloxacin was not a substrate of OAT1, OAT3, OCT1, OCT2, OATP1B1 or OATP. Delafloxacin was shown to be a substrate of P-gp and BCRP in vitro. The clinical relevance of co-administration of delafloxacin and P-gp and/or BCRP inhibitors is unknown.

Microbiology

Mechanism of Action

Delafloxacin belongs to the fluoroquinolone class of antibacterial drugs and is anionic in nature. The antibacterial activity of delafloxacin is due to the inhibition of both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes which are required for bacterial DNA replication, transcription, repair, and recombination. Delafloxacin exhibits a concentration-dependent bactericidal activity against gram-positive and gram-negative bacteria in vitro.

Resistance

Resistance to fluoroquinolones, including delafloxacin, can occur due to mutations in defined regions of the target bacterial enzymes topoisomerase IV and DNA gyrase referred to as Quinolone-Resistance Determining Regions (QRDRs), or through altered efflux.

Fluoroquinolones, including delafloxacin, have a different chemical structure and mechanism of action relative to other classes of antibacterial compounds (e.g. aminoglycosides, macrolides, β-lactams, glycopeptides, tetracyclines and oxazolidinones).

In vitro resistance to delafloxacin develops by multiple step mutations in the QRDRs of gram-positive and gram-negative bacteria. Delafloxacin-resistant mutants were selected in vitro at a frequency of <10-9.

Although cross-resistance between delafloxacin and other fluoroquinolone-class antibacterial agents has been observed, some isolates resistant to other fluoroquinolone-class antibacterial agents may be susceptible to Baxdela.

Interaction With Other Antimicrobials

In vitro drug combination studies with delafloxacin and aztreonam, ceftazidime, colistin, daptomycin, linezolid, meropenem, tigecycline, trimethoprim/sulfamethoxazole and vancomycin demonstrated neither synergy nor antagonism.

Antimicrobial Activity

Baxdela has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections, [see Indications and Usage (1)].

Aerobic bacteria

Gram-positive bacteria

Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains)
Staphylococcus haemolyticus
Staphylococcus lugdunensis
Streptococcus pyogenes
Streptococcus agalactiae
Streptococcus anginosus Group (including S. anginosus, S. intermedius, and S. constellatus)
Enterococcus faecalis

Gram-negative bacteria

Escherichia coli
Klebsiella pneumoniae
Enterobacter cloacae
Pseudomonas aeruginosa

The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint of delafloxacin against isolates of similar genus or organism group. However, the efficacy of Baxdela in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials.

Aerobic bacteria

Gram-positive bacteria

Streptococcus dysgalactiae

Gram-negative bacteria

Enterobacter aerogenes
Haemophilus parainfluenzae
Klebsiella oxytoca
Proteus mirabilis

Susceptibility Test Methods

When available, the clinical microbiology laboratory should provide cumulative reports of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid in the selection of an appropriate antibacterial drug for treatment.

Dilution Techniques

Quantitative methods are used to determine MICs. These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method 1,3 (broth and/or agar). The MIC values should be interpreted according to criteria provided in Table 5.

Diffusion Techniques

Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method 2,3. This procedure uses paper disks impregnated with 5 mcg of delafloxacin to test the susceptibility of bacteria to delafloxacin. The disk diffusion breakpoints are provided in Table 5.

Table 5 Susceptibility Test Interpretive Criteria for delafloxacin
Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion (Zone Diameter in mm)
Pathogen S I R S I R
S = susceptible; I = intermediate; R = resistant
* The current absence of resistant isolates precludes defining any results other than "Susceptible". Isolates yielding MIC results other than "Susceptible" should be submitted to a reference laboratory for further testing. † includes: S. anginosus, S. constellatus and S. intermedius ‡ E. coli, K. pneumoniae, and E. cloacae only.
Staphylococcus aureus (methicillin-resistant and methicillin-susceptible isolates) ≤ 0.25 0.5 ≥ 1 ≥ 23 20-22 ≤ 19
Staphylococcus haemolyticus ≤ 0.25 0.5 ≥ 1 ≥ 24 21-23 ≤ 20
Streptococcus pyogenes* ≤ 0.06 - - ≥ 20 - -
Streptococcus agalactiae ≤ 0.06 0.12 ≥ 0.25 -
Streptococcus anginosus Group*, † ≤ 0.06 - - ≥ 25 - -
Enterococcus faecalis ≤ 0.12 0.25 ≥ 0.5 ≥ 21 19-20 ≤ 18
Enterobacteriaceae‡ ≤ 0.25 0.5 ≥ 1 ≥22 19-21 ≤ 18
Pseudomonas aeruginosa ≤ 0.5 1 ≥ 2 ≥23 20-22 ≤ 19

A report of Susceptible (S) indicates that the antimicrobial drug is likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the site of infection. A report of Intermediate (I) indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of the drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant (R) indicates that the antimicrobial drug is not likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the infection site; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test 1,2,3. Standard delafloxacin powder should provide the following range of MIC values noted in Table 5. For the diffusion technique using the 5 mcg delafloxacin disk, the criteria in Table 6 should be achieved.

Table 6 Acceptable Quality Control Ranges for Delafloxacin
Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion
(zone diameters in mm)
ATCC = American Type Culture Collection
Staphylococcus aureus ATCC 29213 0.001–0.008 Not applicable
Staphylococcus aureus ATCC 25923 Not applicable 32–40
Enterococcus faecalis ATCC 29212 0.015–0.12 Not applicable
Streptococcus pneumoniae ATCC 49619 0.004–0.015 29–36
Escherichia coli ATCC 25922 0.008–0.03 28–35
Pseudomonas aeruginosa ATCC 27853 0.12–0.5 23–29
Haemophilus influenzae ATCC 49427 0.00025–0.001 40–51

References

  1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition. CLSI document M07-A10. Wayne, PA: Clinical and Laboratory Standards Institute; 2015
  2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests, Approved Standard – Twelfth Edition. CLSI document M02-A12. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.
  3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing – 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017.

FDA Approves Baxdela

The U.S. Food and Drug Administration (FDA) has approved intravenous (IV) and oral formulations of Baxdela (delafloxacin), a fluoroquinolone antibacterial active against both gram-positive and gram-negative pathogens (including MRSA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

How should I store Baxdela?

Tablets:

  • Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep the tablets away from moisture (humidity).

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Baxdela.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

Why is this medication prescribed?

Delafloxacin injection is used treat skin infections caused by bacteria in adults. Delafloxacin is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infections.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Baxdela Interactions

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Some medicines can make delafloxacin much less effective when taken at the same time. If you take any of the following medicines, take your delafloxacin dose 2 hours before or 6 hours after you take the other medicine.

  • antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate;
  • didanosine (Videx) powder or chewable tablets; or
  • vitamin or mineral supplements that contain magnesium, iron, or zinc.

Tell your doctor about all your other medicines, especially:

  • insulin or oral diabetes medicine (check your blood sugar regularly); or
  • steroid medicine (taken by mouth or injected).

This list is not complete. Other drugs may interact with delafloxacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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