TE-DASATINIB dasatinib 50 mg film-coated tablet bottle

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: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; hyprolose; 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: Bottle; Container Material: HDPE; 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

Patient Information leaflet

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TE-DASATINIB?
TE-DASATINIB contains the active ingredient dasatinib. TE-DASATINIB is
used to treat adults and children ages 12 months and
older with chronic myeloid leukaemia (CML).
For more information, see Section 1. Why am I using TE-DASATINIB? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TE-DASATINIB?
Do not use if you have ever had an allergic reaction to TE-DASATINIB
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TE-DASATINIB? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TE-DASATINIB and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TE-DASATINIB?
•
Follow all directions given to you by your doctor or pharmacist
carefully.
•
The usual starting dose is 100 mg once daily (either as one 100 mg
tablet or two 50 mg tablets). The entire dose of 100 mg is to
be taken at one time either in the morning or the evening.
•
The starting dose for children is determined by body weight. The
entire dose prescribed by your doctor should be taken at one
time either in the morning or the evening.
More instructions can be found in Section 4. How do I use
TE-DASATINIB? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TE-DASATINIB?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
TE-DASATINIB.
•
If you become pregnant while you are being treated with this medicine,
tell your doctor immediately.
•
Keep all your doctor's appointments so that your progress can

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