Vepesid

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Etoposide 50mg

Available from:

Link Pharmaceuticals Ltd

INN (International Name):

Etoposide 50 mg

Dosage:

50 mg

Pharmaceutical form:

Capsule

Composition:

Active: Etoposide 50mg Excipient: Citric acid monohydrate Gelatin Glycerol   Iron oxide red Macrogol 400 Propyl hydroxybenzoate Sodium ethyl hydroxybenzoate Titanium dioxide Water  

Units in package:

Blister pack, 20 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Nippon Kayaku Co Ltd

Product summary:

Package - Contents - Shelf Life: Blister pack, - 20 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1982-10-21

Patient Information leaflet

VEPESID® CMI May 2022
1
VEPESID®
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 VEPESID?
VEPESID contains the active ingredient etoposide. VEPESID is used to
treat certain types of lung cancer, leukaemia (blood
cancer),lymphoma (cancer of the lymph glands), and testicular tumours.
For more information, see Section 1. Why am I using VEPESID?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VEPESID?
Do not use if you have ever had an allergic reaction to etoposide 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
VEPESID?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VEPESID 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 VEPESID?
•
VEPESID capsules may be given to you at the hospital or surgery, or
you may take them yourself at home
•
You should take VEPESID capsules on an empty stomach
•
VEPESID is usually given each day for between 3 and 5 days. This is
followed by a treatment-free interval of 2-4 weeks
More instructions can be found in Section 4. How do I use VEPESID?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VEPESID?
THINGS YOU
SHOULD DO
•
Be sure to keep all your doctor's appointments so your progress can be
checked
•
Remind any doctor, dentist, nurse or pharmacist you visit that you are
using VEPESID
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or change the dosage without checking
with your doctor
DRIVING OR USING
MACHINES
•
VEPESID may cause dizziness, light-headedness, tiredness, changes in
vision or vomiting in some people.
If this occurs do not drive.
•
Be caref

Summary of Product characteristics

Vepesid v9.0
1
DATA SHEET
1
PRODUCT NAME
VEPESID
®
50 mg and 100 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pale pink, soft gelatin capsules containing 50 mg or 100 mg etoposide.
Excipients with known effect:
Each 50 mg capsule contains 0.47 mg of parahydroxybenzoate.
Each 100 mg capsule contains 0.61 mg of parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Soft gelatin capsule.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VEPESID
is indicated in the treatment of:
SMALL CELL LUNG CANCER
-
VEPESID
Capsules in combination with other approved chemotherapeutic
agents as first-line treatment in patients with small cell lung
cancer.
HODGKIN'S DISEASE.
MALIGNANT (NON-HODGKIN'S) LYMPHOMAS, ESPECIALLY OF THE HISTIOCYTIC
VARIETY.
ACUTE NON-LYMPHOCYTIC LEUKAEMIA.
TESTICULAR TUMOURS
in combination regimens for the treatment of refractory testicular
tumours
4.2
DOSE AND METHOD OF ADMINISTRATION
VEPESID
should only be administered and monitored under the supervision of a
qualified physician
experienced in the use of anti-neoplastic medicinal products.
The dose of
VEPESID
capsules is based on the recommended dose with consideration given to
the
bioavailability of
VEPESID
capsules appearing to be dependent upon the dose administered. In view
of significant intra-patient variability, dose adjustment may be
required to achieve the desired
therapeutic effect.
The usual dose of
VEPESID
capsules is 100-200 mg/m
2
(body surface area)/day, days 1 to 5 or
200 mg/m
2
/day, days 1, 3 and 5 every 3 to 4 weeks in combination with other
agents approved for use
in the disease to be treated. Dosage should be modified to take into
account the myelosuppressive effects
of other medications in the combination or the effects of prior X-ray
therapy or chemotherapy which
may have compromised bone marrow reserve.
Capsules should be taken on an empty stomach.
ELDERLY:
No dosage adjustment is necessary; however, total dosage per course
should not exceed
Vepesid v9.0
2
650 mg/m
2
.
The usual nu