Estimate CCr with the Cockcroft-Gault formula using total body weight (TBW). For patients whose TBW is greater than their ideal body weight (IBW) by ≥25%, use IBW. Calculate dose using TBW. For patients whose TBW is greater than IBW by ≥25%, use adjusted body weight (IBW + 0.4 × [TBW-IBW]).
IV (Adults): 15 mg/kg every 24 hr for 4–7 days.
Renal Impairment IV (Adults): CCr 30–59 mL/min: 10 mg/kg every 24 hr for 4–7 days; CCr 15–29 mL/min: 10 mg/kg every 48 hr for 4–7 days.
Assess for infection (vital signs, urine, WBC) at beginning of and during therapy.
Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
Evaluate eighth cranial nerve function by audiometry before and throughout therapy. Hearing loss is usually in high-frequency range. Prompt recognition and intervention are essential in preventing permanent damage. Monitor for vestibular dysfunction (vertigo, ataxia, nausea, vomiting). Eighth cranial nerve dysfunction is associated with persistently elevated peak plazomicin levels. Discontinue plazomicin if tinnitus or subjective hearing loss occurs.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of CDAD. May begin up to several wk following cessation of therapy.
Monitor intake and output and daily weight to assess hydration status and renal function.
Assess for signs of superinfection (fever, upper respiratory infection, vaginal itching or discharge, increasing malaise, diarrhea).
Monitor for signs and symptoms of hypersensitivity reactions (rash, pruritus, laryngeal edema, wheezing) during therapy.
Lab Test Considerations:
Monitor CCr prior to starting and daily during therapy.
Toxicity and Overdose:
Monitor blood levels periodically during therapy. Timing of blood levels is important in interpreting results. Draw trough levels within 30 min before infusion of 2nd dose. Extend dosing interval by 1.5 fold (i.e., from every 24 hr to every 36 hr or from every 48 hr to every 72 hr) for patients with plasma trough concentrations ≥3 mcg/mL.
In patients with a known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies. Routine testing for mitochondrial DNA variants not currently recommended.
Intermittent Infusion: Dilution: Dilute solution in 0.9% NaCl or LR for a final volume of 50 mL.Solution is clear, colorless to yellow; do not infusion solutions that are cloudy, discolored or contain particulate matter. Diluted solution is stable at room temperature for 24 hr or 7 days if refrigerated at concentrations of 2.5 mg/mL to 45 mg/mL of 0.9% NaCl or LR.
Explain purpose of plazomicin to patient. Emphasize importance of daily labs to prevent side effects.
Advise patient of the importance of drinking plenty of liquids.
Advise patient to notify health care professional immediately if signs and symptoms of hypersensitivity reaction (rash, hives, itching, swelling of lips, difficulty breathing) or if diarrhea, abdominal cramping, fever, or bloody stools occur. Instruct patient not to treat with antidiarrheals without consulting health care professional.
Advise patient to notify health care professional if changes in hearing or balance or if new onset or changes in preexisting buzzing or roaring in ears occur, even if they occur after the completion of therapy.
Advise patient to report the signs of superinfection (black, furry overgrowth on the tongue; vaginal itching or discharge; loose or foul-smelling stools).
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during therapy. Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.