VELABINE vinorelbine (as tartrate) 80 mg soft capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vinorelbine tartrate, Quantity: 110.8 mg (Equivalent: vinorelbine, Qty 80 mg)

Available from:

Luminarie Pty Ltd

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: iron oxide yellow; macrogol 400; polysorbate 80; Gelatin; purified water; titanium dioxide; partially dehydrated liquid sorbitol

Administration route:

Oral

Units in package:

1 capsule

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Non-small cell lung cancer: Velabine is indicated for the first line treatment of advanced non-small cell lung cancer, as a single agent or in combination. ,Breast cancer: Velabine is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.

Product summary:

Visual Identification: oblong-shaped pale yellow soft capsule; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2023-02-14

Patient Information leaflet

VELABINE
1
VELABINE
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 TAKING VELABINE CAPSULES?
VELABINE contains the active ingredient vinorelbine tartrate. VELABINE
is used to treat lung cancer and advanced breast cancer.
For more information, see Section 1. Why am I taking VELABINE
capsules? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE VELABINE CAPSULES?
Do not use if you have ever had an allergic reaction to VELABINE
capsules 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 take
VELABINE capsules? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VELABINE capsules 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 TAKE VELABINE CAPSULES?
Swallow your VELABINE capsules whole with a full glass of water,
without chewing or sucking the capsule.
More instructions can be found in Section 4. How do I take VELABINE
capsules? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING VELABINE CAPSULES?
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 VELABINE capsules, tell your
doctor immediately.
THINGS YOU
SHOULD NOT DO
•
You should not breast-feed while you are being treated with VELABINE
capsules.
•
Men being treated with VELABINE capsules 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 had a yell

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – VELABINE (VINORELBINE)
SOFT CAPSULES
1
NAME OF THE MEDICINE
Vinorelbine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules contain 20 mg, 30 mg and 80 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: oval-shaped light brown soft capsule.
30 mg soft capsule: oblong-shaped pink soft capsule.
80 mg soft capsule: oblong-shaped pale yellow soft capsule.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER
VELABINE is indicated for the first line treatment of advanced
non-small cell lung cancer, as a single
agent or in combination.
BREAST CANCER
VELABINE is indicated for the treatment of advanced breast cancer
after failure of standard therapy as
a single agent or in combination.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS
_SINGLE AGENT _
The recommended regimen is:
First three administrations: 60 mg/m
2
, administered once weekly.
Subsequent administrations:
Beyond the third administration, increasing the dose of vinorelbine
soft capsules 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 below 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