Delafloxacin
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Boxed warning
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) WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, and EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning.
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 )
Dosing in kidney impairment
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/1.73m 2 ). In patients with severe renal impairment receiving BAXDELA intravenously, closely monitor serum creatinine levels and eGFR [see Use in Specific Populations ] .
If serum creatinine level increases, consider switching to BAXDELA Tablets. Discontinue BAXDELA if eGFR decreases to < 15 mL/min/1.73 m 2 . [See table below.]
| Estimated Glomerular Filtration Rate (eGFR)(mL/min/1.73m2)Estimate of GFR based on a Modification of Diet in Renal Disease (MDRD) equation. | Recommended Dosage Regimen for BAXDELAFor a total treatment duration of 5 to 14 days for the treatment of ABSSSI and 5 to 10 days for the treatment of CABP. | |
|---|---|---|
| Oral | IntravenousAll intravenous doses of BAXDELA are administered over 60 minutes. | |
| 30-89 | No dosage adjustment | No dosage adjustment |
| 15-29 | No dosage adjustment | 200 mg every 12 hours |
| End Stage Renal Disease (ESRD) (< 15 including hemodialysis) | Not RecommendedNot recommended due to insufficient information to provide dosing recommendations. | |
| 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. | |
Dosing in liver impairment
Hepatic Impairment No dosage adjustment is necessary for BAXDELA in patients with hepatic impairment [see Clinical Pharmacology ].
Preparation and administration
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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 ] .
BAXDELA Tablets can be taken with or without food [see Clinical Pharmacology ] . 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 ].
Do NOT co-infuse BAXDELA for Injection with other medications [see Dosage and Administration ] .
Preparation and Administration of BAXDELA for Injection Intravenous Solution Reconstitution and Dilution 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. 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: [See table below.] 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.
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 ] .
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.
| 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 Or300 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 Or450 mg BAXDELA tablet orally every 12 hours. | 5 to 14 |
| CABP | 5 to 10 |
| 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. | |
| BAXDELA for Injection Dose | Volume of Reconstituted Solution to Withdraw |
|---|---|
| 300 mg | 12 mL |
| 200 mg | 8 mL |
Drug interactions
Check delafloxacin against a medication listLabel text (3 paragraphs)
7 DRUG INTERACTIONS
7.1 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 [see Dosage and Administration (2.1) ] . There are no data concerning an interaction of intravenous BAXDELA with oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, BAXDELA should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.1) ] .
Supplement interactions
Dietary supplement interactions
3 noted- Simultaneous use of calcium supplements and quinolone antibiotics—such as ciprofloxacin (Cipro), gemifloxacin (Factive), and moxifloxacin (Avelox)—can reduce the absorption of quinolones. Taking the antibiotic 2 hours before or 2 hours after calcium supplements prevents this effect.
- Magnesium can form insoluble complexes with tetracyclines, such as demeclocycline (Declomycin) and doxycycline (Vibramycin), and with quinolone antibiotics, such as ciprofloxacin (Cipro) and levofloxacin (Levaquin). These antibiotics should be taken at least 2 hours before or 4 to 6 hours after a magnesium-containing supplement.
- Both quinolone antibiotics (such as Cipro) and tetracycline antibiotics (such as Achromycin and Sumycin) might interact with zinc in the gastrointestinal tract, which could inhibit the absorption of both zinc and the antibiotic if they are taken at the same time. Taking the antibiotic at least 2 hours before or 4 to 6 hours after the zinc supplement minimizes this interaction.
Contraindications
4 CONTRAINDICATIONS 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 [see Warnings and Precautions (5.6) ] . Known hypersensitivity to BAXDELA or other fluoroquinolones. ( 4 , 5.6 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
E*Likelihood score E*: Unproven but suspected cause of clinically apparent liver injury.
Delafloxacin is a fourth generation fluoroquinolone with expanded activity against gram-positive bacteria as well as atypical pathogens. Delafloxacin has been linked to mild ALT elevations during therapy, but has yet to be linked to instances of idiosyncratic acute liver injury with symptoms and jaundice as have been described with other fluoroquinolones.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 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…
Breastfeeding (LactMed)
No information is available on the use of delafloxacin during breastfeeding. Fluoroquinolones have traditionally not been used in infants because of concern about adverse effects on the infants' developing joints. However, recent studies indicate little risk. The calcium in milk might prevent absorption of fluoroquinolones in milk, but insufficient data exist to prove or disprove this assertion. Use of delafloxacin is acceptable in nursing mothers. However, it is preferable to use an alternate drug for which safety information is available.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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