DASATINIB-TEVA FC TABLET 20MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dasatinib monohydrate eqv. to Dasatinib

Available from:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC code:

L01EA02

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Dasatinib monohydrate eqv. to Dasatinib 20 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

PLIVA Croatia Ltd

Authorization status:

ACTIVE

Authorization date:

2023-03-02

Summary of Product characteristics

DASATINIB-TEVA FC TABLETS
1
NAME OF THE MEDICINAL PRODUCT
Dasatinib-Teva FC tablet 20mg
Dasatinib-Teva FC tablet 50mg
Dasatinib-Teva FC tablet 70mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
20MG: Each film-coated tablet contains 20.739mg of Dasatinib
monohydrate, equivalent to 20mg of Dasatinib.
50MG: Each film-coated tablet contains 51.847mg of Dasatinib
monohydrate, equivalent to 50mg of Dasatinib.
70MG: Each film-coated tablet contains 72.585mg of Dasatinib
monohydrate, equivalent to 70mg of Dasatinib.
Excipients
Tablet core: Lactose monohydrate, Microcrystalline cellulose,
Hydroxypropylcellulose, Croscarmellose sodium, Magnesium
stearate.
Film-coating: Hypromellose, Titanium dioxide (E171), Triacetin
(E1518).
3
PHARMACEUTICAL FORM
Film-coated tablet.
20MG: White to off-white, round film-coated tablet with bevelled edges
and with “20” debossed on one side of the tablet.
50MG: White to off-white, oval film-coated tablet with bevelled edges
and with “50” debossed on one side of the tablet.
70MG: White to off-white, round film-coated tablet with bevelled edges
and with “70” debossed on one side of the tablet.
4
INDICATIONS AND USAGE
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.
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.
5
DOSAGE AND ADMINISTRATION
5.1
DOSAGE OF DASATINIB IN ADULT PATIENTS
The recommended starting dosage of Dasatinib for chronic phase CML in
adults is 100 mg administered orally once daily.
The recommended starting