Cisplatin - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Cisplatin. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING Cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Cumulative renal toxicity associated with cisplatin is severe. Other major dose-related toxicities are myelosuppression, nausea, and vomiting. Ototoxicity, which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant. Anaphylactic-like reactions to cisplatin have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of cisplatin administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS ). Exercise caution to prevent inadvertent cisplatin overdose. Doses greater than 100 mg/m2/cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent cisplatin overdose due to confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle.
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.
These neuropathies may be irreversible and are seen as paresthesias in a stocking-glove distribution, areflexia, and loss of proprioception and vibratory sensation.
Elderly patients may be more susceptible to peripheral neuropathy (see PRECAUTIONS , Geriatric Use ).
Loss of motor function has also been reported.
Anaphylactic-like reactions to cisplatin have been reported.
These reactions have occurred within minutes of administration to patients with prior exposure to cisplatin, and have been alleviated by administration of epinephrine, corticosteroids, and antihistamines.
Cisplatin can commonly cause ototoxicity which is cumulative and may be severe.
Audiometric testing should be performed prior to initiating therapy and prior to each subsequent dose of drug (see ADVERSE REACTIONS ).
All pediatric patients receiving cisplatin should have audiometric testing at baseline, prior to each subsequent dose of drug and for several years post therapy.
Cisplatin can cause fetal harm when administered to a pregnant woman.
Cisplatin is mutagenic in bacteria and produces chromosome aberrations in animal cells in tissue culture.
In mice cisplatin is teratogenic and embryotoxic.
If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Patients should be advised to avoid becoming pregnant.
The carcinogenic effect of cisplatin was studied in BD IX rats.
Cisplatin was administered intraperitoneally (i.p.) to 50 BD IX rats for 3 weeks, 3 x 1 mg/kg body weight per week.
Four hundred and fifty-five days after the first application, 33 animals died, 13 of them related to malignancies: 12 leukemias and 1 renal fibrosarcoma.
The development of acute leukemia coincident with the use of cisplatin has been reported.
In these reports, cisplatin was generally given in combination with other leukemogenic agents.
Injection site reactions may occur during the administration of cisplatin (see ADVERSE REACTIONS ).
Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration.
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