Navelbine 20mg soft capsule
Pierre Fabre Limited
contact details
Active ingredient
vinorelbine tartrate
Legal Category
POM: Prescription only medicine
1. Name of the medicinal product
NAVELBINE® 20 mg soft capsule
2. Qualitative and quantitative composition
Each soft capsule contains 20mg vinorelbine as tartrate
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Soft capsule.
Light brown soft capsule printed N20.
4. Clinical particulars
4.1 Therapeutic indications
As a single agent or in combination for:
• The first line treatment of stage 3 or 4 non small cell lung cancer.
• The treatment of advanced breast cancer stage 3 and 4 relapsing after or refractory to an anthracycline containing regimen.
4.2 Posology and method of administration
In adult patients
As a single agent, the recommended regimen is:
First three administrations
60mg/m2 of body surface area, administered once weekly
Subsequent administrations
Beyond the third administration, it is recommended to increase the dose of Navelbine to 80mg/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 60mg/m2.
Neutrophil count during the first 3 administrations of 60 mg/m2/week
 Neutrophils
> 1000
 Neutrophils
≥ 500 and < 1000
(1 episode)
 Neutrophils
≥ 500 and < 1000
(2 episodes)
 Neutrophils
< 500
Recommended dose starting with the 4th administration
 80
 80
 60
 60
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 60mg/m2 per week during the 3 following administrations.
If the neutrophil count is below 1500 /mm3 and/or the platelet count below 100000/mm3, then the treatment should be delayed until recovery.
Neutrophil count beyond the 4th administration of 80 mg/m2/week
 Neutrophils
> 1000
 Neutrophils
≥ 500 and < 1000
(1 episode)
 Neutrophils
≥ 500 and < 1000
(2 episodes)
 Neutrophils
< 500
Recommended dose starting with the next administration
80
60
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 convenience.
Capsules of different strengths (20, 30, 80 mg) are available in order to choose the adequate combination for the right dosage.
The following table gives the dose required for appropriate ranges of body surface area (BSA).
 60 mg/m2
 80 mg/m2
BSA (m2)
 Dose (mg)
 Dose (mg)
0.95 to 1.04

1.05 to 1.14

1.15 to 1.24

1.25 to 1.34

1.35 to 1.44

1.4