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CARBOPLATIN is a brand name for Carboplatin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
CARBOPLATIN INJECTION is contraindicated in patients with preexisting severe renal impairment unless in the judgement of the physician and patient, the possible benefits of treatment outweigh the risks. CARBOPLATIN INJECTION should not be employed in severely myelosuppressed patients and/or in patients with bleeding tumors.
CARBOPLATIN INJECTION is also contraindicated in patients with a history of severe allergic reactions to carboplatin, other platinum containing compounds, or mannitol. WARNINGS CARBOPLATIN INJECTION should be used only by physicians experienced with cancer chemotherapeutic drugs.
Blood counts as well as renal and hepatic function tests must be done regularly and the drug should be discontinued if abnormal depression of the bone marrow or abnormal renal or hepatic function is seen. Its carcinogenic potential has not been studied, but compounds with similar mechanisms of action and mutagenicity have been reported to be carcinogenic.
Hematologic Toxicity Leukopenia, neutropenia and thrombocytopenia are dose-dependent and dose-limiting. Peripheral blood counts should be monitored during carboplatin treatment frequently and, in case of toxicity, until recovery is achieved.
Severity of myelosuppression is increased in patients with prior treatment (in particular with cisplatin) and/or impaired kidney function. Initial CARBOPLATIN INJECTION dosages in these groups should be appropriately reduced (see DOSAGE AND ADMINISTRATION) and the effects carefully monitored through frequent blood counts between courses.
CARBOPLATIN INJECTION courses should not be repeated more frequently than monthly under normal 5 circumstances. Administration of CARBOPLATIN INJECTION in combination with other myelosuppressive compounds must be planned very carefully with respect to dosages and timing in order to minimize additive effects.
Anemia is frequent and cumulative. Transfusional support is often needed during treatment, particularly in patients receiving prolonged therapy. Neurologic Toxicity Although peripheral neurologic toxicity is generally rare and mild, its frequency is increased in patients older than 65 years and/or in patients previously treated with cisplatin.
Stabilization or amelioration of pre-existing cisplatin-induced neurotoxicity has occurred in about half the patients receiving carboplatin as secondary treatment. Visual disturbances, including loss of vision, have been reported rarely after the use of carboplatin, in doses higher than those recommended in patients with renal impairment.
Vision appears to recover totally or to a significant extent within weeks of stopping these high doses. Use in Pregnancy CARBOPLATIN INJECTION can cause fetal harm when administered to a pregnant woman. Carboplatin has been shown to be embryotoxic and teratogenic in rats receiving the drug during organogenesis as well as mutagenic in several experimental systems.
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No controlled studies in pregnant women have been conducted. 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. Women with child-bearing potential should be advised to avoid becoming pregnant.
Other 6 Although carboplatin has limited nephrotoxic potential, concomitant treatment with aminoglycosides has resulted in episodes of increased renal and audiologic toxicity. Clinically significant hearing loss has been reported to occur in pediatric patients when carboplatin was administered at higher than recommended doses in combination with other ototoxic agents.
Very high dosages of carboplatin (up to five times the single agent recommended dose or more) has resulted in severe abnormalities in hepatic and renal function. As with other platinum compounds, allergic reactions to carboplatin has been reported.
These may occur within minutes of administration and should be managed with appropriate supportive therapy. Carboplatin can induce nausea and vomiting, which can be more severe in previously treated patients (particularly in patients previously pretreated with cisplatin).
Premedication with antiemetics and prolongation of time of carboplatin administration by continuous infusion or over five consecutive days have been reported to be useful in reducing the incidence and intensity of this adverse event.
PRECAUTIONS Peripheral blood counts, renal and hepatic function tests should be monitored closely. Blood counts are recommended at the beginning of the therapy and weekly to assess hematologic nadir for subsequent dose adjustments. Leukopenia and thrombocytopenia are at their lowest levels between days 14 and 28 and 14 and 21, respectively, after initial therapy.
Should the white blood cell count fall below 2,000 cells/mm3 or the platelet count fall below 50,000 cells/mm3, consideration should be given to discontinuation of CARBOPLATIN INJECTION treatment until bone marrow recovery, which usually occurs in 5 to 6 weeks.
Renal toxicity is usually not dose-limiting in patients receiving carboplatin nor does it require preventive measures such as high-volume fluid hydration or forced diuresis. Nevertheless, increasing blood urea or serum creatinine levels can occur in about 6 to 14% of the patients.
7 Renal function impairment, as defined by a decrease in the creatinine clearance below 60 mL/min, may be observed in about 27% of the patients. The incidence and severity of nephrotoxicity may increase in patients who have impaired kidney function before carboplatin treatment.
It is not clear whether an appropriate hydration program might overcome such effect. Dosage reduction or discontinuation of therapy is required in the presence of severe alteration of renal function. Neurotoxicity is usually limited to paresthesias and decreased deep tendon reflexes.
The frequency and intensity of this side effect increase in patients previously treated with cisplatin. Thus neurologic evaluations should be performed on a regular basis. After […]