OXALIPLATIN SUN oxaliplatin 100 mg/20 mL concentrated solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxaliplatin, Quantity: 100 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Oxaliplatin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; lactose monohydrate

Administration route:

Intravenous

Units in package:

One vial packed in an outer carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: - Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumour; - Treatment of advanced colorectal cancer

Product summary:

Visual Identification: Clear and colourless solution free from visible particulates; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-06-28

Patient Information leaflet

Oxaliplatin SUN
1
OXALIPLATIN SUN
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.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING OXALIPLATIN SUN?
Oxaliplatin SUN contains the active ingredient oxaliplatin.
Oxaliplatin SUN is used to treat cancer of the large intestine and
rectum (colorectal cancer).
For more information, see Section 1. Why am I using Oxaliplatin SUN in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OXALIPLATIN SUN?
Do not use if you have ever had an allergic reaction to Oxaliplatin
SUN 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
Oxaliplatin SUN in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Oxaliplatin SUN 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 OXALIPLATIN SUN?
•
Oxaliplatin SUN will be given to you as an infusion into one of your
veins (this is called an intravenous infusion). The
infusion will be given over 2-6 hours.
•
The usual dose is 85mg/m2 every two weeks. Your doctor may change the
dose in some circumstances.
•
Each course of treatment is called a cycle; your doctor will tell you
how many cycles you will receive.
More instructions can be found in Section 4. How do I use [medicine
name]?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OXALIPLATIN SUN?
THINGS YOU
SHOULD DO
•
You must tell your doctor if:
□
you have had a reaction to any other platinum compound
□
you have severe kidney disease, nerve damage (neuropathy) or any other
medical condition
□
you are taking any other medicines, includi

Summary of Product characteristics

Oxaliplatin SUN PI v04_12 Apr 2021
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION – OXALIPLATIN SUN
(OXALIPLATIN) CONCENTRATED SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Oxaliplatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxaliplatin is a white to off-white crystalline powder. It is slightly
soluble in water, very slightly
soluble in methanol and practically insoluble in ethanol.
Oxaliplatin concentrated solution for injection also contains lactose
monohydrate and water for
injections.
3
PHARMACEUTICAL FORM
Concentrated solution for injection
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Oxaliplatin, in combination with fluorouracil and folinic acid, is
indicated for:
•
Adjuvant treatment of stage III (Duke’s C) colon cancer after
complete resection of the
primary tumour
•
Treatment of advanced colorectal cancer
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
In combination with fluorouracil and folinic acid the recommended dose
for the treatment of
advanced colorectal cancer is 85mg/m
2
intravenously repeated every two weeks.
In combination with fluorouracil and folinic acid the recommended dose
for adjuvant treatment
is 85mg/m
2
intravenously repeated every two weeks for 12 cycles (6 months).
DOSAGE MODIFICATION
Prior to each treatment cycle, patients should be evaluated for
toxicity and the dose of oxaliplatin
adjusted accordingly.
Neurological Toxicity
If acute neurological reactions occur e.g. acute pharyngolaryngeal
dysaesthesia, increase the
oxaliplatin infusion time from 2 hours to 6 hours. This decreases C
max
by 30% and may lessen
acute toxicities.
Oxaliplatin SUN PI v04_12 Apr 2021
Page 2 of 25
If sensory loss or paraesthesia persists longer than 7 days or
interferes with function (grade 2
toxicity), reduce oxaliplatin dose by 25%.
If sensory loss or paraesthesia interferes with activities of daily
living (grade
3
toxicity),
oxaliplatin should be discontinued.
Haematological Toxicity
If haematological toxicity (neutrophils <1.5 x 10
9
/L or platelets <75 x 10
9
/L) is present before
star