Navelbine

Navelbine Dosage/Direction for Use

vinorelbine tartrate

Manufacturer:

OEP Phils

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
As a single agent: The recommended regimen is: First three administrations: 60 mg/m2 of body surface area, administered once weekly.
Subsequent administrations: Beyond the third administration, it is recommended to increase the dose of vinorelbine to 80 mg/m2 once weekly except in those patients for whom the neutrophil count dropped once below 500/mm3 or more than once between 500 and 1000/mm3 during the first three administrations at 60 mg/m2. (See Table 1.)

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Dose modification: For any administration planned to be given at 80 mg/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. (See Table 2.)

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It is possible to re-escalate 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.
Administration: Vinorelbine Soft-Gelatin capsule must be given strictly by the oral route. It should be swallowed with water without chewing or sucking the capsule. It is recommended to take the capsule with some food.
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.
Administration in patients with liver insufficiency: Vinorelbine can be administered at the standard dose of 60 mg/m2/week in patients with mild liver impairment (bilirubin <1.5 x ULN, and ALAT and/or ASAT from 1.5 to 2.5 x ULN). In patients with moderate liver impairment (bilirubin from 1.5 to 3 x ULN, whatever the levels of ALAT and ASAT), Vinorelbine should be administered at a dose of 50 mg/m2/week. The administration of vinorelbine in patients with severe hepatic impairment is contraindicated.
Administration in patients with renal insufficiency: Given the minor renal excretion, there is no pharmacokinetic justification for reducing the dose of vinorelbine in patients with serious renal insufficiency.
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