delafloxacin (Rx)

Brand and Other Names:Baxdela
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 300mg/vial (equivalent to 433mg delafloxacin meglumine)

tablet

  • 450mg (equivalent to 649mg delafloxacin meglumine)

Skin and Skin Structure Infections

Indicated for treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria

300 mg IV q12hr for 5-14 days, OR

300 mg IV q12hr, then switch to a 450-mg tablet PO q12hr for 5-14 days, OR

450 mg PO q12hr for 5-14 days

Community-acquired Bacterial Pneumonia

Indicated for treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible bacteria

300 mg IV q12hr for 5-10 days, OR

300 mg IV q12hr, then switch to a 450-mg tablet PO q12hr for 5-10 days, OR

450 mg PO q12hr for 5-10 days

Dosage Modifications

Renal impairment

  • IV
    • CrCl 30-89 mL/min: No dosage adjustment needed
    • CrCl 15-29 mL/min: 200 mg IV q12hr OR 200 mg IV q12hr, then switch to 450 mg PO q12hr
    • CrCl <15 mL/min: Not recommended
  • PO
    • CrCl 15-89 mL/min: No dosage adjustment needed
    • CrCl <15mL/min: Not recommended

Hepatic impairment

  • No dosage adjustment needed

Dosing Considerations

Susceptible bacterial

  • ABSSSI
    • Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains), S haemolyticus, S lugdunensis, Streptococcus pyogenes, S agalactiae, Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Pseudomonas aeruginosa
  • CABP
    • Streptococcus pneumoniae, S aureus (methicillin-susceptible [MSSA] isolates only), K pneumoniae, E coli, P aeruginosa, Haemophilus influenzae, H parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae

Safety and efficacy not established

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Interactions

Interaction Checker

and delafloxacin

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Nausea (8%)

            Diarrhea (8%)

            Headache (3%)

            Transaminase elevations (3%)

            Vomiting (2%)

            <2%

            • Cardiac disorders: Sinus tachycardia, palpitations, bradycardia
            • Ear and labyrinth disorders: Tinnitus, vertigo
            • Eye disorders: Vision blurred
            • General disorders and administration site conditions: Infusion site extravasation, infusion site bruise, discomfort, edema, erythema, irritation, pain, phlebitis, swelling, thrombosis
            • Gastrointestinal disorders: Abdominal pain, dyspepsia
            • Immune system disorders: Hypersensitivity
            • Infections and infestations: Clostridium difficile infection, fungal infection, oral candidiasis, vulvovaginal candidiasis
            • Laboratory Investigations: Blood alkaline phosphatase increased, blood creatinine increased, blood creatine phosphokinase increased
            • Metabolism and nutrition disorders: Hyperglycemia, hypoglycemia
            • Musculoskeletal and connective tissue disorders: Myalgia
            • Nervous system disorders: Dizziness, hypoesthesia, paraesthesia, dysgeusia, presyncope, syncope
            • Psychiatric disorders: Anxiety, insomnia, abnormal dreams
            • Renal and urinary: Renal impairment, renal failure
            • Skin and subcutaneous tissue disorders: Pruritus, urticaria, dermatitis, rash
            • Vascular disorders: Flushing, hypotension, hypertension, phlebitis
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            Warnings

            Black Box Warnings

            Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects

            Discontinue the drug immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions

            May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with known history of myasthenia gravis

            Serious adverse effects and limitations-of-use

            • Both oral and injectable fluoroquinolones are associated with disabling adverse effects involving tendons, muscles, joints, nerves and the central nervous system
            • These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent
            • Because the risk of these serious adverse effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options
            • For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia, among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option

            Contraindications

            Hypersensitivity to delafloxacin or its components or other fluoroquinolones

            Cautions

            Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions from different body systems, including tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and CNS effects (eg, hallucinations, anxiety, depression, insomnia, severe headaches, confusion)

            Risk of tendinitis and tendon rupture in all ages; the Achilles tendon is most frequently involved, but rupture has also been reported with the rotator cuff, hand, biceps, thumb, and other tendons

            Fluoroquinolones are associated with increased risk of peripheral neuropathy; sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported

            Fluoroquinolones elicit neuromuscular blocking activity and may exacerbate muscle weakness with myasthenia gravis

            Serious and occasional fatal hypersensitivity reactions (including after first dose) reported

            Clostridium difficile-associated diarrhea (CDAD) reported with use of nearly all systemic antibiotics

            Prescribing an antibiotic in the absence of proven or strongly suspected bacterial infection is unlikely to provide benefit and increases risk developing drug-resistant bacteria

            Increased risk of aortic aneurysm and dissection within 2 months following fluoroquinolone use observed in epidemiologic studies, particularly in elderly patients; etiology has not been identified; reserve use in patients with known or at greater risk for aortic aneurysm only when there are no alternative antibacterial treatments available

            Blood glucose disturbances reported with fluoroquinolones, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (eg, glyburide) or with insulin; careful blood glucose monitoring recommended; severe cases of hypoglycemia resulting in coma or death reported with other fluoroquinolones

            Central nervous effects

            • If the following adverse effects occur, discontinue delafloxacin immediately and institute appropriate therapy
            • Psychiatric effects
              • Associated with increased risk of psychiatric adverse reactions, including: toxic psychosis, hallucinations, paranoia, depression, suicidal thoughts or acts, delirium, disorientation, confusion, disturbances in attention, anxiety, agitation, nervousness, insomnia, nightmares, or memory impairment; may occur after the first dose
              • If reactions occur, discontinue therapy and institute appropriate measures
            • CNS effects
              • Associated with increased risk of seizures, increased intracranial pressure (including pseudotumor cerebri), dizziness, and tremors
              • Assess benefits and risks of use in patients with known or suspected CNS disorders (eg, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold
              • If reactions occur, discontinue therapy and institute appropriate measures

            Drug interaction overview

            • Do not coadminister IV delafloxacin in the same IV line with any solution containing multivalent cations (eg, magnesium)
            • Chelation
              • Fluoroquinolones form chelates with alkaline earth and transition metal cations
              • Delafloxacin PO administration with antacids containing aluminum or magnesium, with sucralfate, with metal cations (eg, iron), or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations (eg, didanosine buffered tablets for oral suspension or the pediatric powder for oral solution), may substantially interfere with the absorption and decrease systemic exposure
              • Administer delafloxacin at least 2 hr before or 6 hr after the aforementioned agents
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            Pregnancy

            Pregnancy

            Data are limited regarding use in pregnant women and are insufficient to inform a drug-associated risk of major birth defects and miscarriages

            Animal studies

            • When administered PO to rats during organogenesis, no malformation or fetal death were observed at doses up to 7 times the estimated clinical exposure based on AUC
            • When rats were dosed with the IV form in late gestation and during lactation, no adverse effects on offspring were observed

            Lactation

            Unknown if distributed in human breast milk

            Excreted in the breast milk of rats

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Fluoroquinolone antibiotic; inhibits both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes, which are required for bacterial DNA replication, transcription, repair, and recombination

            Absorption

            Peak plasma concentration

            • Oral: 7.17 mcg/mL (single 450-mg dose); 7.45 mcg/mL (steady-state)
            • IV: 8.94 mcg/mL (single 300-mg dose); 9.29 mcg/mL (steady-state)

            Peak plasma time

            • Oral: 0.75 hr (single 450-mg dose); 1 hr (steady-state)
            • IV: 1 hr (single 300-mg dose); 1 hr (steady-state)

            AUC

            • Oral: 22.7 mcg·hr/mL (single 450-mg dose); 30.8 mcg·hr/mL (steady-state)
            • IV: 21.8 mcg·hr/mL (single 300-mg dose); 23.4 mcg·hr/mL (steady-state)

            Distribution

            Protein bound: ~84% (primarily albumin)

            Vd: 30-48 L

            Metabolism

            Glucuronidation is the primary metabolic pathway, with oxidative metabolism representing about 1% of an administered dose

            Glucuronidation is mediated mainly by UGT1A1, UGT1A3, and UGT2B15

            Elimination

            Half-life: 3.7 hr (single IV dose); 4.2-8.5 hr (multiple PO doses)

            Total clearance: 16.3 L/hr (single IV dose)

            Renal clearance: 35-45% of total clearance

            Excretion

            • IV: 65% urine; 28% feces
            • PO: 50% urine; 48% feces
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            Administration

            IV Compatibilities

            Solutions: D5W, 0.9% NaCl

            Y-site: Line should be flushed before and after IV infusion

            IV Preparation

            Reconstitute 300-mg vial with 10.5 mL D5W or 0.9% NaCl, resulting in 300 mg/12 mL (25 mg/mL)

            Shake vial vigorously until contents are completely dissolved; solution should appear clear yellow to amber colored

            Further dilute reconstituted solution to a total volume of 250 mL with D5W or 0.9% NaCl to achieve a final concentration of 1.2 mg/mL prior to administration

            IV Administration

            Infuse IV via volume control set or piggyback container

            Infuse IV over 60 minutes

            Oral Administration

            May take with or without food

            Missed dose: Take as soon as possible within 4 hr of missed dose; if >4 hr since missed dose, wait until next scheduled dose

            Storage

            Tablets and lyophilized powder: Store at controlled room temperature of 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

            Reconstituted vial: Up to 24 hr refrigerated (2-8ºC [36-46ºF]) or at controlled room temperature until further diluted for IV infusion; do not freeze

            Diluted solution: Up to 24 hr refrigerated or at controlled room; do not freeze

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.