Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Nephrotoxicity Dose-related and cumulative renal insufficiency, including acute renal failure, is the major dose-limiting toxicity of cisplatin.
Renal toxicity has been noted in 28% to 36% of patients treated with a single dose of 50 mg/m 2 .
It is first noted during the second week after a dose and is manifested by elevations in BUN and creatinine, serum uric acid and/or a decrease in creatinine clearance.
Renal toxicity becomes more prolonged and severe with repeated courses of the drug.
Renal function must return to normal before another dose of cisplatin can be given.
Elderly patients may be more susceptible to nephrotoxicity (see PRECAUTIONS, Geriatric Use ).
Impairment of renal function has been associated with renal tubular damage.
The administration of cisplatin using a 6 hour to 8 hour infusion with intravenous hydration, and mannitol has been used to reduce nephrotoxicity.
However, renal toxicity still can occur after utilization of these procedures.
Ototoxicity Ototoxicity has been observed in up to 31% of patients treated with a single dose of cisplatin 50 mg/m 2 , and is manifested by tinnitus and/or hearing loss in the high frequency range (4,000 to 8,000 Hz).
WARNINGS Cisplatin produces cumulative nephrotoxicity which is potentiated by aminoglycoside antibiotics.
The serum creatinine, blood urea nitrogen (BUN), creatinine clearance, and magnesium, sodium, potassium, and calcium levels should be measured prior to initiating therapy, and prior to each subsequent course.
At the recommended dosage, cisplatin should not be given more frequently than once every 3 to 4 weeks (see ADVERSE REACTIONS ).
Elderly patients may be more susceptible to nephrotoxicity (see PRECAUTIONS, Geriatric Use ).
There are reports of severe neuropathies in patients in whom regimens are employed using higher doses of cisplatin or greater dose frequencies than those recommended.
Like all medications, Cisplatin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: