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Navelbine Injection

Navelbine Injection Dosage/Direction for Use

vinorelbine

Manufacturer:

Transfarma Medica Indah

Marketer:

A Menarini
Full Prescribing Info
Dosage/Direction for Use
Strictly by intravenous administration after appropriate dilution. The use of intrathecal route is contra-indicated.
It is recommended to infuse Navelbine over 6-10 minutes after dilution in 20-50 ml of normal saline solution or 5% dextrose solution. Administration should always be followed with at least 250 ml of an isotonic solution infusion to flush the vein.
In monotherapy, the usual dose given is 25-30 mg/m2 once weekly.
In combination chemotherapy the dose may be the same while the frequency of administration reduced, i.e.: day 1 and 5 every 3 weeks or day 1 and 8 every 3 weeks according to treatment protocol.
Dose modifications: No dose adjustments are required for renal insufficiency, given the minor renal excretion. If moderate or severe neurotoxicity develops, Navelbine should be discontinued.
The dosage should be adjusted according to hematologic toxicity or hepatic insufficiency, whichever results in the lower dose.
Dose modification for hepatic insufficiency: Navelbine should be administered with caution to patients with hepatic insufficiency. In patients who develop hyperbilirubinemia during treatment with Navelbine, the dose should be adjusted for total bilirubin according to table as follows: (see Table 2.)


Click on icon to see table/diagram/image


Dose modifications for hematologic toxicity: Granulocyte counts should be ≥1500 cells/mm3 prior to the administration of Navelbine. If the neutrophil count is below 1500/mm3 and/or the platelet count is below 100000/mm3, then the treatment should be delayesd until recovery. Repeat neutrophil count is 1 week. If 3 consecutive weekly doses are held because neutrophil count is <1500 cells/mm3, discontinue Navelbine.
Note: For patients during treatment with Navelbine who have experienced fever and/or sepsis while granulocytopenia or had 2 consecutive weekly doses held due to granulocytopenia, subsequent doses of Navelbine should be: 22.5 mg/m2 for granulocytes ≥1500 cells/mm.
Dose modification for concurrent Hematologic toxicity and Hepatic Insufficiency: In patients with both hematologic toxicity and hepatic insufficiency, use the lower of the doses determined from Dose modifications for hematologic toxicity and Dose modifications for hepatic insufficiency.
Administration in the elderly: Clinical experience has not identified relevant differences among elderly patients with regard to the response rate, although greater sensitivity in some of these patients cannot be excluded. Age does not modify the pharmacokinetics of vinorelbine.
Administration in children: Safety and efficacy in children have not been established and administration is therefore not recommended.
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