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Cisplatin

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Cisplatin

WARNINGS

Cisplatin (cisplatin injection) produces cumulative nephrotoxicity which is potentiated by aminoglycoside antibiotics. The serum creatinine, 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 (cisplatin injection) should not be given more frequently than once every 3 to 4 weeks (see ADVERSE REACTIONS section). 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 (cisplatin injection) 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 (cisplatin injection) have been reported. These reactions have occurred within minutes of administration to patients with prior exposure to cisplatin (cisplatin injection) , and have been alleviated by administration of epinephrine, corticosteriods, and antihistamines.

Since ototoxicity of cisplatin (cisplatin injection) is cumulative, audiometric testing should be performed prior to initiating therapy and prior to each subsequent dose of drug (see ADVERSE REACTIONS section).

Cisplatin (cisplatin injection) can cause fetal harm when administered to a pregnant woman. Cisplatin (cisplatin injection) is mutagenic in bacteria and produces chromosome aberrations in animal cells in tissue culture. In mice, cisplatin (cisplatin injection) 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 (cisplatin injection) was studied in BD IX rats. Cisplatin (cisplatin injection) was administered 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 (cisplatin injection) has rarely been reported in humans. In these reports, cisplatin (cisplatin injection) was generally given in combination with other leukemogenic agents.

PRECAUTIONS

Peripheral blood counts should be monitored weekly. Liver function should be monitored periodically. Neurologic examination should also be performed regularly (see ADVERSE REACTIONS section).

Carcinogenesis, Mutagenesis, Impairment of Fertility- see WARNINGS section.

Pregnancy: Teratogenic Effects, Pregnancy Category D- see WARNINGS section.

Nursing Mothers - Cisplatin (cisplatin injection) has been reported to be found in human milk; patients receiving cisplatin (cisplatin injection) should not breast feed.

Pediatric Use - Safety and effectiveness in pediatric patients have not been established.

Geriatric Use - Insufficient data are available from clinical trials of cisplatin (cisplatin injection) in the treatment of metastatic testicular tumors or advanced bladder cancer to determine whether elderly patients respond differently than younger patients. In four clinical trials of combination chemotherapy for advanced ovarian carcinoma, 1484 patients received cisplatin (cisplatin injection) either in combination with cyclophosphamide or paclitaxel. Of these, 426 (29%) were older than 65 years. In these trials, age was not found to be a prognostic factor for survival. However, in a later secondary analysis for one of these trials, elderly patients were found to have shorter survival compared with younger patients. In all four trials, elderly patients experienced more severe neutropenia than younger patients. Higher incidences of severe thrombocytopenia and leukopenia were also seen in elderly compared with younger patients, although not in all cisplatin (cisplatin injection) -containing treatment arms. In the two trials where nonhematologic toxicity was evaluated according to age, elderly patients had a numerically higher incidence of peripheral neuropathy than younger patients. Other reported clinical experience suggests that elderly patients may be more susceptible to myelosuppression, infectious complications, and nephrotoxicity than younger patients.

Cisplatin (cisplatin injection) is known to be substantially excreted by the kidney and is contraindicated in patients with preexisting renal impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

Last reviewed on RxList: 6/13/2008
This monograph has been modified to include the generic and brand name in many instances.

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