SPRYCEL dasatinib 20 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dasatinib, Quantity: 20 mg

Available from:

Bristol-Myers Squibb Australia Pty Ltd

INN (International Name):

Dasatinib

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; lactose monohydrate; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SPRYCEL is indicated for the treatment of adults aged 18 years or over with: - newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase. - chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukameia with resistance or intolerance to prior therapy including imatinib. - newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukameia integrated with chemotherapy. - Philadelphia chromosome positive acute lymphoblastic leukamia with resistance or intolerance to prior therapy.,SPRYCEL is indicated for the treatment of paediatric patients with: - Ph+ CML in the chronic phase. - newly diagnosed Ph+ ALL in combination with chemotherapy.

Product summary:

Visual Identification: White to off-white, biconvex, round tablet with "BMS" debossed on one side and "527" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2007-01-15

Patient Information leaflet

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 and
children ages 12 months and older
with chronic myeloid leukaemia
(CML). It is also used to treat adults
and children ages 12 months and
older 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 across all phases who
are no longer benefiting from
other therapies for these diseases
(resistance) or in patients who
experience severe side effects to
other therapies (intolerance),

Summary of Product characteristics

AU_PI_SPRYCEL_V20.0
1
AUSTRALIAN PRODUCT INFORMATION – SPRYCEL
®
(DASATINIB)
1
NAME OF THE MEDICINE
Dasatinib.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SPRYCEL film-coated tablets contain 20, 50, 70 or 100 mg of dasatinib.
Dasatinib is a white to off-white powder.
SPRYCEL film-coated tablets contain lactose monohydrate. For the full
list of excipients, see Section
6.1 List of excipients.
3
PHARMACEUTICAL FORM
SPRYCEL film-coated tablets.
The 20 mg tablets are white to off-white, biconvex, round tablets with
“BMS” debossed on one side
and “527” on the other side.
The 50 mg tablets are oval shaped and debossed “BMS” on one side
and “528” on the other side.
The 70 mg tablets are white to off-white, biconvex, round tablets with
“BMS” debossed on one side
and “524” on the other side.
The 100 mg tablets are oval shaped and debossed “BMS 100” on one
side and “852” on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SPRYCEL is indicated for the treatment of adults aged 18 years or over
with:
•
newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid
leukaemia in the
chronic phase.
•
chronic, accelerated or myeloid or lymphoid blast phase chronic
myeloid leukaemia with
resistance or intolerance to prior therapy including imatinib.
•
newly diagnosed Philadelphia chromosome positive acute lymphoblastic
leukaemia integrated
with chemotherapy.
•
Philadelphia
chromosome
positive
acute
lymphoblastic
leukaemia
with
resistance
or
intolerance to prior therapy.
SPRYCEL is indicated for the treatment of paediatric patients with:
•
Ph+ CML in the chronic phase.
•
newly diagnosed Ph+ ALL in combination with chemotherapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
To achieve the recommended dose, SPRYCEL is available as 20 mg, 50 mg,
70 mg and 100 mg film-
coated tablets. Dose increase or reduction is recommended based on
patient response and tolerability.
AU_PI_SPRYCEL_V20.0
2
ADULT DOSAGE
CML
The recommended starting dosage of SPRYCEL for chronic phase CML