CABAZITAXEL JUNO cabazitaxel 60 mg/1.5 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cabazitaxel, Quantity: 60 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: polysorbate 80; citric acid

Administration route:

Intravenous Infusion

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CABAZITAXEL JUNO 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: Clear yellow to brownish-yellow viscous solution.; Container Type: Multiple containers; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-07-23

Patient Information leaflet

CABAZITAXEL JUNO
_Cabazitaxel (ca-ba-zi-tax-el)_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cabazitaxel Juno.
It does not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
Keep this leaflet in a safe place as
you may need to read it again.
WHAT CABAZITAXEL
JUNO IS USED FOR
The name of your medicine is
Cabazitaxel Juno. It belongs to a
group of medicines called 'taxanes'
used to treat cancers. Cabazitaxel
Juno is used to treat prostate cancer
that has progressed after having had
other chemotherapy. It works by
stopping cells from growing and
multiplying.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU ARE GIVEN
CABAZITAXEL JUNO
DO NOT RECEIVE CABAZITAXEL JUNO IF:
•
the number of your white blood
cells is too low (neutrophil counts
of 1,500 per cubic millimetre, or
less - your doctor will advise you
on this),
•
you have a liver disease
•
you are pregnant or breast-
feeding
•
you have recently received or are
about to receive a vaccine against
yellow fever.
DO NOT RECEIVE CABAZITAXEL JUNO IF
YOU ARE ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
DO NOT RECEIVE CABAZITAXEL JUNO IF
YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT.
Cabazitaxel Juno may affect your
developing baby if you are given
Cabazitaxel Juno during pregnancy.
If your partner is pregnant or is
planning on becoming pregnant,
ensure to

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – CABAZITAXEL JUNO (CABAZITAXEL)
INJECTION CONCENTRATE
1
NAME OF THE MEDICINE
Cabazitaxel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CABAZITAXEL JUNO injection concentrate contains 60 mg cabazitaxel in
1.5 mL.
The diluent for CABAZITAXEL JUNO contains ethanol in water for
injections.
Excipients with known effect: diluent contains alcohol as 16.4% v/v
ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CABAZITAXEL JUNO (cabazitaxel) 60 mg/1.5 mL concentrate is a sterile,
non-pyrogenic, clear yellow to
brownish-yellow viscous solution, free from visible extraneous matter.
The diluent for CABAZITAXEL JUNO is a clear, colourless, sterile, and
non-pyrogenic, solution, free from
visible extraneous matter.
.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
CABAZITAXEL JUNO 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
D
OSE AND METHOD OF ADMINISTRATION
The use of cabazitaxel 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.
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
with
the
following
intravenous medications to reduce the risk and severity of a
hypersensitivity reaction:
•
antihistamine (equivalent to dexchlorpheniramine 5 mg or
diphenhydramine 25 mg),
•
corticosteroid (dexamethasone 8 mg or equivalent) and with
•
H
2
antagonist (ranitidine or equivalent).
•
Antiemetic prophylaxis is recommended and can be given orally or
intravenously as needed
(see 4.4
SPECIAL WARNINGS AND PR