Navelbine Capsule Dosage/Direction for Use

Navelbine must be strictly given by the oral route.
In monotherapy, the usual dose given is 60-80 mg/m² once weekly.
In combination chemotherapy, the dose and schedule will be adapted according to treatment protocol.
Even for patients with BSA ≥2 m² the total dose should never exceed 120 mg per week at 60 mg/m² and 160 mg per week at 80 mg/m².
Dose modification: For any administration planned to be given at 80mg/m² if the neutrophil count is below 500/mm³ or more than once between 500 and 1000/mm³, the administration should be delayed until recovery and the dose reduced from 80 to 60 mg/m² per week during the 3 following administrations.
If the neutrophil count is below 1500/mm³ and/or the platelet count is below 100000/mm³, then the treatment should be delayed until recovery. (See Table 1.)


Click on icon to see table/diagram/image


It is possible to reescalate the dose from 60 to 80 mg/m² per week if the neutrophil count did not drop below 500/mm³ or more than once between 500 and 1000/mm³ during 3 administrations given at 60 mg/m² according to the rules previously defined for the first 3 administrations. For combination regimens, the dose and schedule will be adapted to the treatment protocol.
Based on clinical studies, the oral dose of 80 mg/m² was demonstrated to correspond to 30 mg/m² of the iv form and 60 mg/m² to 25 mg/m².
This has been the base for combination regimens alternating iv and oral forms improving patient’s convenience. For combination regimens, the dose and schedule will be adapted to the treatment protocol. Even for patients with BSA ≥2 m² the total dose should never exceed 120 mg per week at 60 mg/m² and 160 mg per week at 80 mg/m².
The following table gives the dose required for appropriate ranges of body surface area (BSA): (See Table 2.)


Click on icon to see table/diagram/image


Administration: Navelbine must be given strictly by the oral route. Navelbine must be swallowed with water, without chewing or sucking the capsule. It is recommended to administer the capsule with some food.
Administration in patients with liver insufficiency: Navelbine can be administered at the standard dose of 60 mg/m²/week in patients with mild hepatic disorder (bilirubin <1.5 x ULN, and ALT and/or AST between 1.5 and 2.5 x ULN). In patients with moderate hepatic disorder (bilirubin between 1.5 and 3 x ULN, independent of ALT and AST), Navelbine should be administered at a dose of 50 mg/m²/week. The administration of Navelbine in patients with severe hepatic impairment is contra-indicated.
Administration in patients with renal insufficiency: Given the minor renal excretion, there is no pharmacokinetic justification for reducing the dose of Navelbine in patients with serious renal insufficiency.
Administration in the elderly: Clinical experience has not detected any significant 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.