Delafloxacin

Severe and sometimes fatal hypersensitivity reactions, including anaphylaxis, have occurred with fluoroquinolone therapy. May occur after first or subsequent doses, and may be accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and pruritus. Discontinue therapy at the first sign of skin rash or any other sign of a hypersensitivity reaction.

Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions that may occur together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue delafloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Patients of any age or without preexisting risk factors have experienced these reactions; may occur within hours to weeks after initiation. - CNS effects: Fluoroquinolones have been associated with an increased risk of CNS effects including seizures, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis; may also cause nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or actions. May occur following the first dose; discontinue immediately and avoid further use of fluoroquinolones in patients who experience these reactions. Use with caution in patients with known or suspected CNS disorder, or risk factors that may predispose to seizures or lower the seizure threshold. - Peripheral neuropathy: Fluoroquinolones have been associated with an increased risk of peripheral neuropathy; may occur soon after initiation of therapy and may be irreversible; discontinue if symptoms of sensory or sensorimotor neuropathy occur. Avoid use in patients who have previously experienced peripheral neuropathy. - Tendinitis/Tendon ruptu

Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment. Disease-related concerns:

May exacerbate muscle weakness related to myasthenia gravis; avoid use in patients with known history of myasthenia gravis. Cases of severe exacerbations, including the need for ventilatory support, and deaths have been reported.

Use with caution and reduce dose in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/minute/1.73 m2). Use is not recommended in patients with end-stage renal disease (eGFR 2). See also “Dosage form specific issues: Injection”. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Adverse effects (eg, tendon rupture) may be increased in elderly patients. Dosage form specific issues:

Avoid use of IV formulation in patients with end-stage renal disease (eGFR 2); injection contains excipient cyclodextrin (sulfobutylether-beta-cyclodextrin [SBECD]), which may accumulate. Closely monitor serum creatinine levels in patients with severe renal impairment (eGFR 15 to 29 mL/minute/1.73 m2) and consider using oral delafloxacin in these patients if serum creatinine levels increase; discontinue use if eGFR decreases to 2.