CARBOPLATIN EBEWE
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Package(a):
VIAL: 1 x 15 ml (150 mg carboplatin).
Dosage(a):
Previously untreated adult patients with normal renal function receive 400 mg/m
2 body surfaces as I.V. short term infusion (15-60 minutes). Therapy cycles can be repeated after 4 weeks therapy free interval. Patients with risks (previously treated with myelosuppressive active drugs and/or radiation therapy or general poor conditions) should be treated with an initial dose of 300-320 mg/m
2. In patients with impaired renal function, the dose must be reduced and adapted to the glomerular filtration rate. A suggested dosage schedule based on creatinine clearance is as follows: 40 ml/minute clearance: 400 mg/m
2; 20-39 ml/minute: 250 mg/m
2; 0-19 ml/minute: 150 mg/m
2.
Children: No specific dosage recommendations because of lack of experience.
Prescribing Restrictions: None
Package(b):
VIAL: 1 x 45 ml (450 mg carboplatin).
Dosage(b):
Previously untreated adult patients with normal renal function receive 400 mg/m
2 body surfaces as I.V. short term infusion (15-60 minutes). Therapy cycles can be repeated after 4 weeks therapy free interval. Patients with risks (previously treated with myelosuppressive active drugs and/or radiation therapy or general poor conditions) should be treated with an initial dose of 300-320 mg/m
2. In patients with impaired renal function, the dose must be reduced and adapted to the glomerular filtration rate. A suggested dosage schedule based on creatinine clearance is as follows: 40 ml/minute clearance: 400 mg/m
2; 20-39 ml/minute: 250 mg/m
2; 0-19 ml/minute: 150 mg/m
2.
Children: No specific dosage recommendations because of lack of experience.
Prescribing Restrictions: None
Indications:
Alone or in combination with other antineoplastic agents in the treatment of advanced ovarian carcinoma and metastatic small cell lung cancer.
Contra-Indications:
Hypersensitivity to drug components or other platinum containing agents. Pregnancy and lactation. Severe myelosuppression. Renal impairment (glomerular filtration rate <30 ml/minute). Hearing impairment.
Special Precautions:
To be administered after preparation of the solution as I.V. short-time infusion over a period of 15-60 minutes. Solution should be discarded after eight hours from dilution if stored at room temperature or after 24 hours if stored refrigerated. Should be administered under the direction of an oncologist. Carboplatin myelosuppression is closely related to its renal clearance. Patients with abnormal kidney function or receiving concomitant therapy with other potentially nephrotoxic drugs. Renal function parameters should be carefully assessed before and during therapy. Should not be repeated more frequently than monthly under normal circumstances. Weekly monitoring of peripheral blood counts is recommended during the initial course of therapy. Combination therapy with other myelosuppressive compounds must be planned very carefully with respect to dosages and timing. Neurological evaluations should be performed regularly. Cases of hepatic toxicity associated with renal toxicity have been reported with very high doses. See prescribing information for full details. May impair concentration and ability in driving and operating machinery.
Pregnancy and lactation: Should not be used.
Side Effects:
Myelosuppression, thrombocytopenia, leucopenia and anemia. Increased blood urea or serum creatinine levels can occur. Renal function impairment. Decreased serum electrolytes. Hyponatremia. Nausea, vomiting, infrequent allergic reactions. Subclinical decrease in hearing acuity. Incidence of peripheral neuropathies after treatment is 4%. Transient visual disturbances, abnormalities in liver function tests. See prescribing information for full details.
Drug Interactions:
Other myelosuppressive compounds. Aminoglycocides or other agents with similar toxicity. See prescribing information for full details.
