Navelbine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Vinorelbine tartrate 41.55mg equivalent to vinorelbine 30 mg

Available from:

New Zealand Medical & Scientific Ltd

INN (International Name):

Vinorelbine tartrate 41.55 mg (equivalent to vinorelbine 30 mg)

Dosage:

30 mg

Pharmaceutical form:

Soft gelatin capsule

Composition:

Active: Vinorelbine tartrate 41.55mg equivalent to vinorelbine 30 mg Excipient: Edible Ink Red Ethanol Gelatin Glycerol   Anidrisorb 85/70 85% Phosal 53 MCT Iron oxide red Macrogol 400 Medium-chain triglycerides Purified water   Titanium dioxide

Units in package:

Blister pack, 1 capsule

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pierre Fabre Medicament - Plantes et Industrie

Therapeutic indications:

First line treatment of advanced non-small cell lung cancer (NSCLC) as a single agent or in combination

Product summary:

Package - Contents - Shelf Life: Blister pack, - 1 capsules - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2004-04-21

Patient Information leaflet

Navelbine Oral
1
NAVELBINE ORAL
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NAVELBINEORAL?
Navelbine Oral contains the active ingredient vinorelbine tartrate.
Navelbine Oral is used to treat lung cancer and advanced
breast cancer. For more information, see Section 1. Why am I using
Navelbine Oral? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NAVELBINEORAL?
Do not use if you have ever had an allergic reaction to or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Navelbine Oral? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Navelbine Oral and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NAVELBINE ORAL?
•
Navelbine Oral is given as a capsule. Swallow your Navelbine Oral
capsule whole with a full glass of water, without chewing
or sucking the capsule.
More instructions can be found in Section 4. How do I use Navelbine
Oral? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NAVELBINE ORAL?
THINGS YOU
SHOULD DO
•
Keep all appointments with your doctor to check on your progress and
monitor side effects.
•
If you become pregnant while taking Navelbine Oral, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
You should not breast-feed while you are being treated with Navelbine
Oral.
•
Men being treated with Navelbine Oral are advised not to father a
child during and up to a minimum
of 3 months after treatment.
•
Do not use if you have or have had an infection or high temperature in
the last 2 weeks
•
Do not use if you are currently receiving radiation therapy.
•
Do not use if you have recently

Summary of Product characteristics

Page 1 of 22
NEW ZEALAND DATA SHEET
1
NAVELBINE
® (SOFT CAPSULES)
NAVELBINE
®
20 mg, 30 mg Soft Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules contain 20 mg or 30 mg vinorelbine (as tartrate).
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Soft capsule
20 mg soft capsule:
light brown soft capsule printed N20.
30 mg soft capsule:
pink soft capsule printed N30.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER
NAVELBINE Oral is indicated for the first line treatment of advanced
non-small cell lung
cancer, as a single agent or in combination.
BREAST CANCER
NAVELBINE Oral is indicated for the treatment of advanced breast
cancer after failure of
standard therapy as a single agent or in combination.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
_SINGLE AGENT _
The recommended regimen is:
First three administrations: 60 mg/m
2
, administered once weekly.
Page 2 of 22
Subsequent administrations:
Beyond the third administration, increasing the dose of NAVELBINE Oral
to 80 mg/m
2
once
weekly is recommended, except in those patients for whom the
neutrophil count has dropped
once below 500/mm
3
or more than once between 500 and 1000/mm
3
during the first
3 administrations at 60 mg/m
2
.
_DOSE MODIFICATIONS ACCORDING TO HAEMATOLOGICAL STATUS _
If the neutrophil count is below 1500/mm
3
and/or the platelet count is between 75,000 and
100 000/mm
3
, then treatment should be delayed until recovery.
TABLE 1
NEUTROPHIL COUNT DURING THE
FIRST 3 ADMINISTRATIONS AT
60 MG/M
2
/WEEK
NEUTROPHILS
>1000
NEUTROPHILS
≥500 AND <1000
(1 EPISODE)
NEUTROPHILS
≥500 AND <1000
(2 EPISODES)
NEUTROPHILS
<500
RECOMMENDED DOSE FOR 4
TH
AND SUBSEQUENT
ADMINISTRATIONS
80
80
60
60
For any administration planned at the 80 mg/m
2
/week dose, if the neutrophil count falls
below 500/mm
3
or more than once between 500 and 1000/mm
3
, the dose must be delayed
until recovery and reduced from 80 to 60 mg/m
2
per week during the 3 subsequent
administrations.
TABLE 2
NEUTROP