Sprycel

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dasatinib 50mg;  

Available from:

Bristol-Myers Squibb (NZ) Limited

INN (International Name):

Dasatinib 50 mg

Dosage:

50 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Dasatinib 50mg   Excipient: Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white YS-1-18177-A

Units in package:

Blister pack, Al/Al, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Siegfried Evionnaz SA

Therapeutic indications:

· SPRYCEL® (dasatinib) is indicated for the treatment of adults aged 18 years or over with newly diagnosed chronic myeloid leukaemia (CML). · SPRYCEL® (dasatinib) is indicated for the treatment of adults aged 18 years or over with chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. · SPRYCEL® (dasatinib) is indicated for the treatment of paediatric patients with Philadelphia chromosome positive chronic myeloid leukaemia (CML) in the chronic phase

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/Al - 60 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 60 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2006-05-18

Patient Information leaflet

SPRYCEL
®
1
SPRYCEL
®
(SPRY-SELL)
_Dasatinib (duh-sat-in-ib) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about SPRYCEL
P
®
P
. 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 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 (int

Summary of Product characteristics

Sprycel v 22.0
1
DATA SHEET
1
PRODUCT NAME
SPRYCEL®
20 mg film-coated tablets
SPRYCEL®
50 mg film-coated tablets
SPRYCEL®
70 mg film-coated tablets
SPRYCEL®
100 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SPRYCEL 20 mg film-coated tablets
Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Excipient with known effect
Each film-coated tablet contains 27 mg of lactose monohydrate.
SPRYCEL 50 mg film-coated tablets
Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Excipient with known effect
Each film-coated tablet contains 67.5 mg of lactose monohydrate.
SPRYCEL 70 mg film-coated tablets
Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Excipient with known effect
Each film-coated tablet contains 94.5 mg of lactose monohydrate.
SPRYCEL 100 mg film-coated tablets
Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
Excipient with known effect
Each film-coated tablet contains 135.0 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
SPRYCEL 20 mg film-coated tablets
White to off-white, biconvex, round film-coated tablet with "BMS"
debossed on one side and "527"
on the other side.
SPRYCEL 50 mg film-coated tablets
White to off-white, oval shaped film-coated tablet with "BMS" debossed
on one side and "528" on the
other side.
SPRYCEL 70 mg film-coated tablets
White to off-white, biconvex, round, film-coated tablet with "BMS"
debossed on one side and "524"
on the other side.
SPRYCEL 100 mg film-coated tablets
White to off-white, oval shaped film-coated tablet with "BMS 100"
debossed on one side and "852"
on the other side.
Sprycel v 22.0
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SPRYCEL
is indicated for the treatment of adults aged 18 years or over with:
•
newly diagnosed chronic myeloid leukaemia (CML).
•
chronic, accelerated or myeloid or lymphoid blast phase chronic
myeloid leukaemia with
resistance or intolerance to prior therapy including imatinib.
•
Philadelphia c