JEVTANA cabazitaxel 60 mg/1.5 mL concentrated injection vial

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

cabazitaxel acetone solvate, Quantity: 64.17 mg

Beschikbaar vanaf:

Sanofi-Aventis Australia Pty Ltd

INN (Algemene Internationale Benaming):

cabazitaxel acetone solvate

farmaceutische vorm:

Diluent, not applicable

Samenstelling:

Excipient Ingredients: water for injections; ethanol

Toedieningsweg:

Intravenous

Eenheden in pakket:

1 drug concentrate vial and 1 diluent vial

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Jevtana 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 samenvatting:

Visual Identification: Clear, colourless solution; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisatie-status:

Licence status A

Autorisatie datum:

2011-12-08

Bijsluiter

JEVTANA
®
J
e
v
t
a
n
a
®
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 JEVTANA?
Jevtana contains the active ingredient cabazitaxel. Jevtana is used to
treat prostate cancer that has progressed after having had
other chemotherapy. For more information, see Section 1. Why am I
using Jevtana? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE JEVTANA?
Do not use if you have ever had an allergic reaction to cabazitaxel or
any of the ingredients listed at the end of the CMI.
Do not use if the number of your white blood cells is too low, you
have a liver disease or if you have recently received or are about to
receive a vaccine against yellow fever.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR IF YOUR PARTNER IS PREGNANT,
PLANS TO BECOME PREGNANT OR BREASTFEED. For more information, see
Section 2. What should I know before I use Jevtana? in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Jevtana 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 IS JEVTANA GIVEN?
•
Jevtana 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.
•
You usually receive your infusion once every 3 weeks.
More instructions can be found in Section 4.How is Jevtana given? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING JEVTANA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or nurse you visit that you are
using Jevtana.
•
Use a condom during sex if your partner is or could become pregnant.
•
Call your doctor immediately if your partner becomes pregnant while
you are being given this medicine
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine unless your doctor tells you to
DRIVING
OR USING
MACHINES
•

Productkenmerken

jevtana-ccdsv10-piv11-10nov20
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION – JEVTANA
®
(CABAZITAXEL)
1
NAME OF THE MEDICINE
Cabazitaxel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The concentrated solution for injection contains 60 mg cabazitaxel in
1.5 mL polysorbate 80.
Diluent contains 13% w/w ethanol in 4.5 mL water for injections.
EXCIPIENTS OF KNOWN EFFECT:
Diluent contains 13% w/w ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The concentrated solution for injection is a clear oily yellow to
brownish yellow solution.
The diluent is a clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Jevtana 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 Jevtana 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.
PREMEDICATION
Premedicate at least 30 minutes prior to each administration of
Jevtana with the following
intravenous medications to reduce the risk and severity of a
hypersensitivity reaction:
jevtana-ccdsv10-piv11-10nov20
Page 2 of 26
antihistamine (equivalent to dexchlorpheniramine 5 mg or
diphenhydramine 25 mg or
equivalent),
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 Section 4.4 Special warnings and precautions for use).
RECOMMENDED DOSAGE
The recommended dose of Jevtana is 20 mg/m2 administered as a 1-hour
intravenous
infusion every 3 weeks in combination with oral prednisone (or
prednisolone) 10 mg
administered daily throughout Jevtana treatment.
A dose of 25 mg/m
2
can be used in select patients at the discretion of the treating
health