CABAZITAXEL EVER PHARMA cabazitaxel 45 mg/4.5 mL concentrated solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cabazitaxel, Quantity: 45 mg

Available from:

Interpharma Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: polysorbate 80; ethanol absolute; macrogol 300; citric acid

Administration route:

Intravenous

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CABAZITAXEL EVER PHARMA in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen.

Product summary:

Visual Identification: The concentrate is a clear slightly yellow oily solution; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-10-27

Patient Information leaflet

CABAZITAXEL EVER PHARMA®
1
CABAZITAXEL EVER PHARMA®
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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I BEING GIVEN CABAZITAXEL EVER PHARMA?
CABAZITAXEL EVER PHARMA contains the active ingredient cabazitaxel.
CABAZITAXEL EVER PHARMA is used to treat prostate
cancer that has progressed after having had other chemotherapy.
For more information, see Section 1. Why am I taking CABAZITAXEL EVER
PHARMA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN CABAZITAXEL EVER PHARMA?
Do not take CABAZITAXEL EVER PHARMA if you have ever had an allergic
reaction to cabazitaxel or any of the ingredients listed
at the end of this CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT, ARE BREASTFEEDING OR PLANNING TO BREASTFEED.
For more information, see Section 2. What should I know before I take
CABAZITAXEL EVER PHARMA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CABAZITAXEL EVER PHARMA 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 WILL I BE GIVEN CABAZITAXEL EVER PHARMA?
•
CABAZITAXEL EVER PHARMA will be given by infusion into one of your
veins (intravenous use). The infusion will last
approximately 1 hour during which you will be in the hospital.
•
The dose will depend on your height and weight. Your doctor will
calculate your body surface area in square meters (m
2
)
and will determine the dose you should receive.
More instructions can be found in Section 4. How do I take CABAZITAXEL
EVER PHARMA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING CABAZITAXEL EVER PHARMA?
THINGS YOU
SHOULD DO
•
Remind any doctor, surgeon, dentist or pharmacist you visit t

Summary of Product characteristics

CABAZITAXEL EVER PHARMA PI, 27 OCTOBER 2020
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION – CABAZITAXEL EVER PHARMA
(CABAZITAXEL
)
CONCENTRATE FOR INJECTION
1
NAME OF THE MEDICINE
Cabazitaxel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NOMINAL VOLUME
ACTIVE INGREDIENT (CABAZITAXEL)
4.5 mL
45 mg
5 mL
50 mg
6 mL
60 mg
EXCIPIENTS WITH KNOWN EFFECT
Each vial of 4.5 mL concentrate contains 888.8 mg of ethanol 100%.
Each vial of 5 mL concentrate contains 987.5 mg of ethanol 100%.
Each vial of 6 mL concentrate contains 1,185 mg of ethanol 100%.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Concentrate solution for injection.
The concentrate is a clear slightly yellow oily solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CABAZITAXEL EVER PHARMA in combination with prednisone or prednisolone
is
indicated for the treatment of patients with metastatic castration
resistant prostate cancer
previously treated with a docetaxel containing regimen.
4.2
DOSE AND METHOD OF ADMINISTRATION
The use of CABAZITAXEL EVER PHARMA should be confined to units
specialised in the
administration of cytotoxics and it should only be administered under
the supervision of a
physician experienced in the use of anticancer chemotherapy.
Facilities and equipment for
the treatment of serious hypersensitivity reactions like hypotension
and bronchospasm
must be available (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR
CABAZITAXEL EVER PHARMA PI, 27 OCTOBER 2020
Page 2 of 26
USE).
Do not use PVC infusion containers (bags or bottles) for the
preparation of the infusion
solution.
Do not use polyurethane infusion sets (tubing, filter, pumps) for the
administration of the
infusion solution.
PREMEDICATION
Premedicate at least 30 minutes prior to each administration of
CABAZITAXEL EVER
PHARMA with the following intravenous medications to reduce the risk
and severity of a
hypersensitivity reaction:
•
antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or
equivalent),
•
corticosteroid (