Cabazitaxel Winthrop

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Cabazitaxel acetone solvate; cabazitaxel; Cabazitaxel

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

CABAZITAXEL WINTHROP
®

1 
CABAZITAXEL WINTHROP
®

_ _
_Cabazitaxel (ca-ba-zi-tax-el) _
CONSUMER MEDICINE INFORMATION (CMI) 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Cabazitaxel 
Winthrop. 
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 
WINTHROP IS USED FOR 
The name of your medicine is 
Cabazitaxel Winthrop. It belongs to a 
group of medicines called 'taxanes' 
used to treat cancers.  Cabazitaxel 
Winthrop 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 WINTHROP 
DO NOT RECEIVE CABAZITAXEL 
WINTHROP IF: 
  the number of your white blood 
cells is too low (neutrophil 
counts≤ 1,500/mm3, 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 
WINTHROP 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,

Summary of Product characteristics

Cabazitaxel Winthrop-ccdsv03-pv3-29may13 
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_Page 1  _

PRODUCT INFORMATION 
CABAZITAXEL WINTHROP
®

NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Cabazitaxel 
CHEMICAL STRUCTURE 
The chemical structure of cabazitaxel is: 

,
O
O
O
HO
O
O
O
O
O
H
O
OH
NH
O
O
O
O

DESCRIPTION 
Cabazitaxel belongs to the taxanes class. It is prepared by
semi synthesis with a precursor 
extracted from yew needles. 
Chemical name of cabazitaxel is
(2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3-
[(tertbutoxycarbonyl)
amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-
5,20-epoxytax-11-en-2-yl benzoate - propan-2-one (1:1). 
Cabazitaxel is a white to off-white powder with a molecular
formula of C
45
H
57
NO
14
,C
3
H
6
O and a 
molecular weight of 894.01 (for the acetone solvate) / 835.93 (for
the solvent free). It is lipophilic, 
practically insoluble in water and soluble in alcohol. 
Cabazitaxel Winthrop (cabazitaxel) 60 mg/1.5 mL concentrate
is a sterile, non-pyrogenic, clear 
yellow to brownish-yellow viscous solution and is available in
single-use vials containing 60 mg 
(1.5 mL) cabazitaxel and 1.56 mg polysorbate 80. 
Each mL of concentrate contains 40 mg cabazitaxel (anhydrous),
1.04 mg polysorbate 80 and citric 
acid.  
Diluent for Cabazitaxel Winthrop is a clear, colourless, sterile,
and non-pyrogenic, solution 
containing 13% (w/w) ethanol in water for injection, 4.5 mL. 
PHARMACOLOGY 
CLASS 
Antineoplastic agent 
ATC code: L01CD04 
SITE AND MODE OF ACTION 
Cabazitaxel is an antineoplastic agent that acts by disrupting the
microtubular network in cells. 
Cabazitaxel binds to tubulin and promotes the assembly of tubulin
into microtubules while 
simultaneously inhibiting their disassembly. This leads to the
stabilisation of microtubules, which 
results in the inhibition of mitotic and interphase cellular
functions. 
PHARMACODYNAMICS 
Cabazitaxel demonstrated a broad spectrum of an