Sprycel

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Dasatinib

Tilgjengelig fra:

Bristol-Myers Squibb Australia Pty Ltd

Klasse:

Medicine Registered

Informasjon til brukeren

SPRYCEL
®

(SPRY-SELL)
_Dasatinib (duh-sat-in-ib)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sprycel
®
. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Sprycel
against the benefits that are expected.
This leaflet does not contain
everything about Sprycel. Your
doctor has been provided with full
information and can answer any
questions you may have. Follow your
doctor's advice even if it differs from
what is in this leaflet.
PLEASE READ THIS LEAFLET CAREFULLY
AND KEEP IT IN A SAFE PLACE SO YOU
MAY REFER TO IT LATER.
WHAT SPRYCEL IS
USED FOR
Sprycel is used to treat adults with
chronic myeloid leukaemia (CML). It
is also used to treat adults who have a
particular form of acute
lymphoblastic leukaemia (ALL)
called Philadelphia chromosome
positive or Ph+ ALL. Leukaemia is a
cancer of immature white blood cells,
which grow in the bone marrow.
Under normal circumstances, as
these white blood cells mature, they
enter the blood stream where they
fight infection and maintain the
body's immune system. In leukaemia,
these immature white blood cells
multiply in an uncontrolled manner,
occupying the bone marrow space
and spilling out into the bloodstream.
As a consequence, the production of
normal red blood cells (oxygen
carrying cells), white blood cells
(cells which fight infection), and
platelets (cells which help blood to
clot) is compromised. Therefore
patients with leukaemia are at risk of
developing serious anaemia,
infections and bleeding.
It is intended that Sprycel be used in
adults with:
•
Newly diagnosed Ph+ CML in
the chronic phase who have not
received any prior therapies, OR
•
Ph+ CML or Ph+ ALL who are
no longer benefiting from other
therapies for these diseases
(resistance) or in patients who
experience severe side effects to
other therapies (intolerance).
Ask your doctor if you have any
questions about why Sprycel was
pre

Preparatomtale

 
Sprycel V9.0 (16 August 2013) 

1 
PRODUCT INFORMATION 

SPRYCEL
®

NAME OF THE MEDICINE 

SPRYCEL
®
 (Dasatinib)  

SPRYCEL
®
 (Dasatinib) is a potent inhibitor of multiple oncogenic kinases, cellular enzymes 
involved in the transmission of growth signals from the cell membrane to the nucleus.   The 
chemical  name  for  dasatinib  is  _N_-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-
piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, 
monohydrate. 
The 
molecular  formula  is  C
22
H
26
C1N
7
O
2
S  •  H
2
O,  which  corresponds  to  a  formula  weight  of 
506.02  (monohydrate).    The  anhydrous  free  base  has  a  molecular  weight  of  488.01.  
Dasatinib drug substance has the following chemical structure: 

The CAS number for dasatinib monohydrate is 863127-77-9.   

DESCRIPTION 

Dasatinib  is  a  white  to  off-white  powder.  The  drug  substance  is  insoluble  in  water 
(0.008 mg/mL) at 24 ± 4 ºC.  The pH of a saturated solution
of dasatinib in water is about 6.0.  
Two  basic  ionization  constants  (pK
a
)  were  determined  to  be  6.8  and  3.1,  and  one  weakly 
acidic pK
a
 was determined to be 10.8.  The solubilities of dasatinib in
various solvents at 24 ± 
4 ºC are as follows: slightly soluble in ethanol (USP), methanol, polyethylene glycol 400, and 
propylene glycol; very slightly soluble in acetone and
acetonitrile; and practically insoluble in 
corn oil. 

SPRYCEL
®
  film  coated  tablets  contain  the  following  inactive  ingredients:  lactose, 
microcrystalline  cellulose,  croscarmellose  sodium,  hydroxpropyl  cellulose  and  magnesium 
stearate.    The  tablet  coating  contains:  hypromellose,  titanium  dioxide  and  polyethylene 
glycol.�