NAVELBINE VIALS

Carcinoma, lung, non-small cell or [Carcinoma, breast ]- Intravenous (over six to ten minutes), 30 mg (base) per square meter of body surface area once a week, as a single agent . The same dose is used in combination therapy with cisplatin, which is given in a dose of 120 mg (base) per square meter of body surface area on Days 1 and 29, followed by one dose every six weeks . Dosage adjustment is recommended according to hematologic toxicity or hepatic insufficiency, as outlined below, whichever results in a lower dose . (If both hematologic and hepatic toxicity occur, the lower of the doses determined from the following is recommended .) Dosage adjustment for hematologic toxicity is- Granulocytes 1500 cells per cubic millimeter (cells/mm ) or more on days of treatment: Give 30 mg (base) per square meter of body surface area . Granulocytes 1000 to 1499 cells/mm on days of treatment: Give 15 mg (base) per square meter of body surface area . Granulocytes less than 1000 cells/mm on days of treatment: Do not administer vinorelbine . Repeat granulocyte count in one week . If three consecutive weekly doses have to be held because of low granulocyte counts, it is recommended that vinorelbine be discontinued . Note: In patients who have experienced fever and/or sepsis while granulocytopenic during vinorelbine therapy or have had two consecutive doses held because of granulocytopenia, subsequent doses should be 22.5 mg (base) per square meter of body surface area (for granulocytes greater than or equal to 1500 cells/mm ) or 11.25 mg (base) per square meter of body surface area (for granulocytes 1000 to 1499 cells/mm ) . Dosage adjustment for hepatic insufficiency is- Total bilirubin 2 mg per deciliter (mg/dL) or less: Give 30 mg (base) per square meter of body surface area . Total bilirubin 2.1 to 3 mg/dL: Give 15 mg (base) per square meter of body surface area . Total bilirubin 3 mg/dL or more: Give 7.5 mg (base) per square meter of body surface area . [Carcinoma, cervical] - Patients have benefited from intravenous doses of 25 to 30 mg per square meter of body surface area, once a week, depending on white blood cell and absolute neutrophil counts. [Carcinoma, ovarian, epithelial] - Patients have benefited from intravenous doses of 18 to 30 mg per square meter of body surface area, once every 7 to 21 days, depending on white blood cell and absolute neutrophil counts.

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PEDIATRIC DOSE:

Safety and efficacy have not been established .

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