DASATINIB APOTEX dasatinib 70 mg film coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dasatinib, Quantity: 70 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: triethyl citrate; hypromellose; colloidal anhydrous silica; hyprolose; lactose monohydrate; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; ethylcellulose; titanium dioxide

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Dasatinib ARX 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 ? Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy

Product summary:

Visual Identification: White to off-white, round, biconvex coated tablet. Engraved "APO" on one side, "DA" over "70" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-07-31

Patient Information leaflet

DASATINIB ARX FILM COATED TABLETS
1
DASATINIB ARX
_Dasatinib _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. 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 this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Dasatinib is used to treat adults aged
18 years or over with:
•
Newly diagnosed Philadelphia
chromosome positive (Ph+)
chronic myeloid leukaemia
(CML) in the chronic phase.
•
Chronic, accelerated or myeloid
or lymphoid blast phase chronic
myeloid leukaemia with
resistance or intolerance to prior
therapy including imatinib.
•
Philadelphia chromosome
positive acute lymphoblastic
leukaemia (ALL) with resistance
or intolerance to prior therapy.
It belongs to a group of medicines
called protein-tyrosinekinase
inhibitors.
This medicine works by inhibiting
the activity of proteins within the
leukaemia cells of patients with CML
or Ph+ ALL. These proteins are
responsible for the uncontrolled
growth of the leukaemia cells. By
inhibiting these proteins dasatinib
kills the leukaemia cells in the bone
marrow and allows normal red cell,
white cell and platelet production to
resume.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN _
There is not enough information to
recommend the use of this medicine
for children under the age of 18
years.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medici

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
DASATINIB ARX (DASATINIB) TABLETS
1
NAME OF THE MEDICINE
Dasatinib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg, 50 mg, 70 mg or 100 mg dasatinib as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Sugars as lactose (monohydrate)
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
20 MG TABLET:
White to off-white, round, biconvex coated tablet. Engraved “APO”
on one side, over “DA” over
“20” on the other side.
50 MG TABLET:
White to off-white, oval, bevelled-edged, biconvex coated tablet.
Engraved “APO” on one side,
“DAS50” on the other side.
70 MG TABLET:
White to off-white, round, biconvex coated tablet. Engraved “APO”
on one side, “DA” over “70”
on the other side.
100 MG TABLET:
White to off-white, oval, bevelled-edged, biconvex coated tablet.
Engraved “APO” on one side,
“DAS100” on the other side.
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dasatinib ARX 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
•
Philadelphia chromosome positive acute lymphoblastic leukaemia with
resistance or
intolerance to prior therapy
4.2
DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
To be administered orally. Tablets must not be crushed or cut in order
to minimize risk of
dermal exposure, they must be swallowed whole. Tablets can be taken
with or without a meal
and should be taken consistently either in the morning or the evening.
DOSAGE
The recommended starting dosage of dasatinib for chronic phase CML is
100 mg administered
orally once daily. The recommended starting dosage of dasatinib for
accelerated phase CML,
myeloid or lymphoid blast phase CML, or Ph+ ALL is 140 mg/day
administered orally o