DASATINIB-TEVA dasatinib 100 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dasatinib, Quantity: 100 mg

Available from:

Teva Pharma Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30

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 100 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 DASATINIB-TEVA?
DASATINIB-TEVA contains the active ingredient dasatinib.
DASATINIB-TEVA 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 DASATINIB-TEVA? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DASATINIB-TEVA?
Do not use if you have ever had an allergic reaction to DASATINIB-TEVA
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 DASATINIB-TEVA? in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DASATINIB-TEVA 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 DASATINIB-TEVA?
•
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
DASATINIB-TEVA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DASATINIB-TEVA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
DASATINIB-TEVA.
•
If you become pregnant while you are being treated with this medicine,
tell your doctor immediately.
•
Keep all your doctor's appointme

Summary of Product characteristics

DASATINIB-TEVA V2.0
1
AUSTRALIAN PRODUCT INFORMATION –
DASATINIB-TEVA
(DASATINIB)
1
NAME OF THE MEDICINE
Dasatinib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DASATINIB-TEVA film-coated tablets contain 20, 50, 70 or 100 mg of
dasatinib.
Dasatinib is a white to off-white powder.
DASATINIB-TEVA film-coated tablets contain lactose monohydrate. For
the full list of excipients,
see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
DASATINIB-TEVA 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
DASATINIB-TEVA 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-TEVA 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, DASATINIB-TEVA 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