Applies to plazomicin: intravenous solution.
Warning
Intravenous route (Solution)
Warning: Nephrotoxicity, Ototoxicity, Neuromuscular Blockade and Fetal HarmNephrotoxicity has been reported with plazomicin. The risk of nephrotoxicity is greater in patients with impaired renal function, the elderly, and in those receiving concomitant nephrotoxic medications. Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy. Therapeutic drug monitoring (TDM) is recommended for complicated urinary tract infection (cUTI) patients with CrCl less than 90 mL/min to avoid potentially toxic levels.Ototoxicity, manifested as hearing loss, tinnitus, and/or vertigo, has been reported with plazomicin. Symptoms of aminoglycoside-associated ototoxicity may be irreversible and may not become evident until after completion of therapy. Aminoglycoside-associated ototoxicity has been observed primarily in patients with a family history of hearing loss, patients with renal impairment, and in patients receiving higher doses and/or longer durations of therapy than recommended.Aminoglycosides have been associated with neuromuscular blockade. During therapy with plazomicin, monitor for adverse reactions associated with neuromuscular blockade, particularly in high-risk patients, such as patients with underlying neuromuscular disorders (including myasthenia gravis) or in patients concomitantly receiving neuromuscular blocking agents.Aminoglycosides, including plazomicin, can cause fetal harm when administered to a pregnant woman.
Serious side effects of Plazomicin
Along with its needed effects, plazomicin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking plazomicin:
More common
- Blood in the urine
- change in the frequency of urination or amount of urine
- difficulty in breathing
- drowsiness
- increased thirst
- loss of appetite
- nausea
- swelling of the feet or lower legs
- vomiting
Less common
- Blurred vision
- cloudy urine
- confusion
- decrease in urine-concentrating ability
- diarrhea
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of fullness in the ears
- headache
- loss of balance
- loss of hearing
- nervousness
- pounding in the ears
- ringing or buzzing in the ears
- slow or fast heartbeat
- trouble in hearing
- unusual tiredness or weakness
Incidence not known
- Burning feeling in the chest or stomach
- chest tightness
- dry mouth
- indigestion
- irregular heartbeat
- mood changes
- muscle pain or cramps
- numbness or tingling in the hands, feet, or lips
- seizures
- stomach upset
- tenderness in the stomach area
Other side effects of Plazomicin
Some side effects of plazomicin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Constipation
For Healthcare Professionals
Applies to plazomicin: intravenous solution.
General
The most commonly reported side effects included serum creatinine increases of 0.5 mg/dL or greater, decreased renal function, and diarrhea.[Ref]
Renal
Serum creatinine increases of at least 0.5 mg/dL above baseline occurred in approximately 7% of patients given this drug, compared to 4% of patients given meropenem; this effect primarily occurred in patients with CrCl 90 mL/min or less, and resulted in trough levels of at least 3 mcg/mL.[Ref]
Common (1% to 10%): Acute kidney injury, chronic kidney disease, creatinine clearance decreased, decreased renal function/renal dysfunction, renal failure, serum creatinine increased
Frequency not reported: Nephrotoxicity[Ref]
Gastrointestinal
Common (1% to 10%): Diarrhea, nausea, vomiting
Frequency not reported: Clostridium difficile-associated diarrhea, constipation, gastritis[Ref]
Cardiovascular
Common (1% to 10%): Hypertension, hypotension[Ref]
Other
Common (1% to 10%): Ototoxicity
Uncommon (0.1% to 1%): Reversible hypoacusis
Frequency not reported: Abnormal audiogram, fetal harm, hearing loss, irreversible tinnitus, tinnitus[Ref]
Nervous system
Common (1% to 10%): Headache
Frequency not reported: Dizziness, neuromuscular blockade, vertigo[Ref]
Hypersensitivity
Frequency not reported: Anaphylactic reactions, hypersensitivity reactions[Ref]
Respiratory
Frequency not reported: Dyspnea[Ref]
Genitourinary
Frequency not reported: Hematuria[Ref]
Metabolic
Frequency not reported: Hypokalemia[Ref]
Hepatic
Frequency not reported: ALT increased[Ref]
