delafloxacin (Rx)

Brand and Other Names:Baxdela
  • Print

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 (see Dosing Considerations)

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

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

Antimicrobial activity

  • Shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
  • Aerobic gram-positive bacteria
    • Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains)
    • Staphylococcus haemolyticus
    • Staphylococcus lugdunensis
    • Streptococcus pyogenes
    • Streptococcus agalactiae
  • Aerobic gram-negative bacteria
    • Escherichia coli
    • Klebsiella pneumoniae
    • Enterobacter cloacae
    • Pseudomonas aeruginosa

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and delafloxacin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            1-10%

            Nausea (8%)

            Diarrhea (8%)

            Headache (3%)

            Transaminase elevations (3%)

            Vomiting (2%)

            Cardiac disorders: Sinus tachycardia, palpitations, bradycardia (<2%)

            Ear and labyrinth disorders: Tinnitus, vertigo (<2%)

            Eye disorders: Vision blurred (<2%)

            General disorders and administration site conditions: Infusion site extravasation, infusion site bruise, discomfort, edema, erythema, irritation, pain, phlebitis, swelling, thrombosis (<2%)

            Gastrointestinal disorders: Abdominal pain, dyspepsia (<2%)

            Immune system disorders: Hypersensitivity (<2%)

            Infections and infestations: Clostridium difficile infection, fungal infection, oral candidiasis, vulvovaginal candidiasis (<2%)

            Laboratory Investigations: Blood alkaline phosphatase increased, blood creatinine increased, blood creatine phosphokinase increased (<2%); blood glucose disturbances

            Metabolism and nutrition disorders: Hyperglycemia, hypoglycemia (<2%)

            Musculoskeletal and connective tissue disorders: Myalgia (<2%)

            Nervous system disorders: Dizziness, hypoesthesia, paraesthesia, dysgeusia, presyncope, syncope (<2%)

            Psychiatric disorders: Anxiety, insomnia, abnormal dreams (<2%)

            Renal and urinary: Renal impairment, renal failure (<2%)

            Skin and subcutaneous tissue disorders: Pruritus, urticaria, dermatitis, rash (<2%)

            Vascular disorders: Flushing, hypotension, hypertension, phlebitis (<2%), increased risk of aortic aneurysm and dissection

            Previous
            Next:

            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

            Documented 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) (see Black Box Warnings)

            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 (see Black Box Warnings)

            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 (see Black Box Warnings)

            Fluoroquinolones elicit neuromuscular blocking activity and may exacerbate muscle weakness with myasthenia gravis (see Black Box Warnings)

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

            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

            CNS effects

            • Fluoroquinolones have been associated with an increased risk of CNS effects, including: convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis
            • May also cause CNS events including: nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide; reactions may occur following the first dose; advise patients to inform their healthcare provider immediately if these reactions occur, discontinue treatment, and institute appropriate care
            • Fluoroquinolone are also known to trigger seizures or lower the seizure threshold; use with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (eg, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (eg, certain drug therapy, renal dysfunction)

            FDA MedWatch Safety Alert

            • Issued 12-20-2018
            • Increase in rate of aortic aneurysm and dissection reported within two months following use of fluoroquinolones, particularly in elderly patients
            • May occur with fluoroquinolones for systemic use (IV or PO)
            • Patients who have an aortic aneurysm or are at risk for an aortic aneurysm (eg, patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions [eg, Marfan syndrome, Ehlers-Danlos syndrome], elderly patients)
            • Prescribe fluoroquinolones to these patients only when no other treatment options are available
            • Advise patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm
            • Stop treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection

            FDA MedWatch Safety Alert

            • Issued July 10, 2018
            • The FDA is strengthening the current warnings in the prescribing information for fluoroquinolone antibiotics to inform clinicians of significant decreases in blood glucose and certain mental health adverse effects
            • Hypoglycemia, sometimes resulting in coma, occurred more frequently in elderly patients or in diabetic patients taking oral hypoglycemic medicine or insulin; if hypoglycemic reaction occurs in a patient being treated discontinue therapy and initiate appropriate treatment immediately
            • Alert patients regarding hypoglycemic symptoms and carefully monitor blood glucose levels; instruct patients how to treat themselves if symptoms of hypoglycemia occur
            • This safety alert affects only systemic formulations; early signs and symptoms of low blood glucose include confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness, and/or unusual anxiety
            • Mental health side effects are to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium
            • Inform patients of the potential risk of psychiatric adverse reactions that can occur after just 1 dose
            • Immediately discontinue treatment if CNS adverse effects occur, including psychiatric adverse reactions, or blood glucose disturbances occur and switch to a nonfluoroquinolone antibiotic if possible

            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
            Previous
            Next:

            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.

            Previous
            Next:

            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

            450-mg oral tablet

            • Absolute bioavailability: 58.8%
            • Peak plasma time: 1 hr
            • AUC: 450 mg PO comparable to 300 mg IV

            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
            Previous
            Next:

            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 with10.5 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: 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

            Reconstituted vial: Up to 24 hr under refrigerated or controlled room temperature until further diluted for IV infusion; do not freeze

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

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.