Vinorelbine Alvogen Dosage/Direction for Use

Posology: Adult patients: 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 <500/mm³ or more than once between 500 and 1,000/mm³ during the first three administrations at 60 mg/m². (See Table 1.)

Click on icon to see table/diagram/image

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 1,000/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 1,500/mm³ and/or the platelet count below 100,000/mm³, then the treatment should be delayed until recovery. (See Table 2.)

Click on icon to see table/diagram/image

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 1,000/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 convenience.
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.
Method of administration: Vinorelbine Alvogen must be given strictly by the oral route.
Vinorelbine Alvogen must be swallowed whole with water, without chewing, sucking or dissolving the capsule.
It is recommended to administer the capsule with some food.
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 (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Safety and efficacy in children have not been established and administration is therefore not recommended.
Hepatic insufficiency: Vinorelbine Alvogen can be administered at the standard dose of 60 mg/m²/week in patients with mild hepatic impairment (bilirubin <1.5 x ULN, and ALAT and/or ASAT between 1.5 and 2.5 x ULN).
In patients with moderate hepatic impairment (bilirubin between 1.5 and 3.0 x ULN, independent of ALAT and/or ASAT level), Vinorelbine Alvogen should be administered at the dose of 50 mg/m²/week.
The administration of Vinorelbine Alvogen in patients with severe hepatic impairment is contraindicated (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Renal insufficiency: Given the minor renal excretion, there is no pharmacokinetic justification for reducing the dose of Vinorelbine Alvogen in patients with serious renal insufficiency (see Precautions and Pharmacology: Pharmacokinetics under Actions).