TE-DASATINIB dasatinib 50 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dasatinib, Quantity: 50 mg

Available from:

Teva Pharma Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Dasatinib 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.,Dasatinib 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, oval film-coated tablets with bevelled,edges and debossed 50 on one side of the tablet.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-03-18

Summary of Product characteristics

TE-DASATINIB V2.0
1
AUSTRALIAN PRODUCT INFORMATION –
TE-DASATINIB
(DASATINIB)
1
NAME OF THE MEDICINE
Dasatinib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TE-DASATINIB film-coated tablets contain 20, 50, 70 or 100 mg of
dasatinib.
Dasatinib is a white to off-white powder.
TE-DASATINIB film-coated tablets contain lactose monohydrate. For the
full list of excipients, see
Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TE-DASATINIB film-coated tablets.
The 20 mg tablets are white to off white, round film-coated tablets
with bevelled edges and
debossed “20” on one side of the tablet.
The 50 mg tablets are white to off white, oval film-coated tablets
with bevelled edges and
debossed ˝50˝ on one side of the tablet.
The 70 mg tablets are white to off white, round film-coated tablets
with bevelled edges and
debossed ˝70˝ on one side of the tablet.
The 100 mg tablets are white to off white, oval film-coated tablets
with bevelled edges and
debossed ˝100˝ on one side of the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TE-DASATINIB 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.
TE-DASATINIB 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, TE-DASATINIB 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.
TE-DASATINIB V