Navelbine Dosage/Direction for Use

Monotherapy: The recommended regimen is as follows: First three administrations: 60 mg/m² of body surface area, administered once per week.
Subsequent administrations: Beyond the third administration, it is recommended that the dose of vinorelbine soft-gelatin capsule be increased to 80 mg/m² once weekly except for patients whose neutrophil count has fallen once below 500/mm³ or more than once to between 500 and 1000/mm³ during the first three dose administrations at 60 mg/m². (See Table 1.)

Click on icon to see table/diagram/image

Dose modification: For any planned administration at the dose of 80 mg/m², if the neutrophil count is below 500/mm³ or has been between 500 and 1000/mm³ more than once, administration should be delayed until this parameter has returned to normal and the dose be reduced from 80 to 60 mg/m² per week for the subsequent 3 administrations. (See Table 2.)

Click on icon to see table/diagram/image

It is possible to increase the dose from 60 to 80 mg/m² per week if the neutrophil count is not below 500/mm³ or between 500 and 1000/mm³ on more than one occasion during the last three administrations at 60 mg/m², consistent with the rules described for the first three administrations.
In combination chemotherapy, the dose and treatment regimen should be adjusted according to the treatment protocol: Clinical trial results show that an oral dose of 80 mg/m² is equivalent to an IV dose of 30 mg/m² and that an oral dose of 60 mg/m² is equivalent to an IV dose of 25 mg/m².
This is based on combination protocols alternating between the IV and oral form which improve patient comfort.
For combination protocols the dose and treatment regimen should be adjusted according to the treatment protocol.
Even for patients with a BSA of ≥2 m², the total dose must never exceed 120 mg per week (60 mg/m² dosage) or 160 mg per week (80 mg/m² dosage).
Administration: Vinorelbine soft-gelatin capsule must be administered strictly by the oral route. It must be swallowed with water without chewing or sucking the capsule. It is recommended that the capsule be taken at the end of a meal.
Administration in the elderly: Clinical experience has not established any significant differences in elderly patients in terms of response rate, although it is not possible to exclude greater sensitivity in some of these patients. Age does not change the pharmacokinetics of vinorelbine.
Administration in children: The safety and efficacy have not been studied in children and as a result administration of vinorelbine is not recommended.
Administration in patients with liver insufficiency: Vinorelbine can be administered at the standard dose of 60 mg/m² per week in patients suffering from mild hepatic disorder (bilirubin <1.5 x ULN and AST and/or ALT 1.5 to 2.5 x ULN). In patients suffering from moderate hepatic disorder (bilirubin 1.5 to 3 x ULN regardless of the ALT and AST), vinorelbine should be administered at a dose of 50 mg/m²/week. Administration of vinorelbine to patients with severe hepatic disorder is not recommended as there is insufficient data to determine the pharmacokinetics, efficacy and safety of vinorelbine in this population.
Administration in patients with renal insufficiency: As renal excretion is low, there is no pharmacokinetic justification to reduce the dose of vinorelbine in patients with renal insufficiency.