SPRYCEL TABLETS 20MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DASATINIB

Available from:

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

ATC code:

L01XE06

Dosage:

20 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

DASATINIB 20 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

AstraZeneca Pharmaceuticals LP

Authorization status:

ACTIVE

Authorization date:

2007-09-14

Patient Information leaflet

 
1

SPRYCEL
®

(DASATINIB) TABLETS 
1 
INDICATIONS AND USAGE 
SPRYCEL
®
 (dasatinib) is indicated for the treatment of adults with 
•
  newly diagnosed Philadelphia chromosome-positive (Ph+)
chronic myeloid leukemia 
(CML) in chronic phase. The effectiveness of SPRYCEL is based on
cytogenetic 
response and major molecular response rates. The trial is ongoing and
further data will 
be required to determine long-term outcome.

•
  chronic, accelerated, or myeloid or lymphoid blast phase CML with
resistance or 
intolerance to prior therapy including imatinib.

•
  Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+
ALL) with 
resistance or intolerance to prior therapy.

2 DOSAGE 
AND 
ADMINISTRATION 
The recommended starting dosage of SPRYCEL (dasatinib) for chronic
phase CML is 100 mg 
administered orally once daily. The recommended starting dosage
of SPRYCEL for accelerated 
phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL is 140 mg,
administered 
orally once daily. Tablets should not be crushed or cut;
they should be swallowed whole. 
SPRYCEL can be taken with or without a meal, either in the morning
or in the evening. 
In clinical studies, treatment with SPRYCEL was continued
until disease progression or until no 
longer tolerated by the patient. The effect of stopping treatment
after the achievement of a 
complete cytogenetic response (CCyR) has not been investigated. 
2.1           DOSE MODIFICATION 
CONCOMITANT STRONG CYP3A4 INDUCERS: The use of concomitant strong
CYP3A4 inducers 
may decrease dasatinib plasma concentrations and should be avoided
(eg, dexamethasone, 
phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital). St.
John's wort may decrease 
dasatinib plasma concentrations unpredictably and should be
avoided. If patients must be 
coadministered a strong CYP3A4 inducer, based on pharmacokinetic
studies, a SPRYCEL dose 
increase should be considered. If the dose of SPRYCEL i

Summary of Product characteristics

1
SPRYCEL

(DASATINIB) TABLETS
1
INDICATIONS AND USAGE
SPRYCEL

(dasatinib) is indicated for the treatment of adult patients with

newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid
leukemia
(CML) in chronic phase.

chronic, accelerated, or myeloid or lymphoid blast phase CML with
resistance or
intolerance to prior therapy including imatinib.

Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+
ALL) with
resistance or intolerance to prior therapy.
SPRYCEL

(dasatinib) is indicated for the treatment of pediatric patients with

newly diagnosed Ph+ CML in chronic phase or Ph+ CML-CP resistant or
intolerant
to prior therapy including imatinib.

newly diagnosed Ph+ ALL in combination with chemotherapy.
2
DOSAGE AND ADMINISTRATION
2.1
DOSAGE OF SPRYCEL IN ADULT PATIENTS
The recommended starting dosage of SPRYCEL (dasatinib) for chronic
phase CML in adults is
100 mg administered orally once daily. The recommended starting dosage
of SPRYCEL for
accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL
in adults is 140 mg,
administered orally once daily. Tablets should not be crushed or cut;
they should be swallowed
whole. SPRYCEL can be taken with or without a meal, either in the
morning or in the evening.
2.2
DOSAGE OF SPRYCEL IN PEDIATRIC PATIENTS WITH CML OR PH+ ALL
The recommended starting dosage for pediatrics is based on body weight
as shown in Table 1. The
recommended dose should be administered orally once daily with or
without food.
Recalculate the
dose every 3 months based on changes in body weight, or more often if
necessary.
Do not crush, cut or chew tablets. Swallow tablets whole.
There are additional administration
considerations for pediatric patients who have difficulty swallowing
tablets whole. Dispersal of
tablets shows a reduction in exposure of dasatinib based on limited
clinical data
_[see Use in _
_Specific Populations (8.3) and Clinical Pharmacology (11)]._
There is no experience with SPRYCEL treatment in children under 1 year