DASATINIB SUN dasatinib 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dasatinib, Quantity: 100 mg

Available from:

Sun Pharma ANZ Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; lactose monohydrate; croscarmellose sodium; calcium hydrogen phosphate; hyprolose; titanium dioxide; hypromellose; triacetin

Administration route:

Oral Application

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DASATINIB SUN 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 SUN 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, biconvex, oval, film-coated tablet debossed with "855" on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-07-20

Patient Information leaflet

Dasatinib SUN
1
DASATINIB SUN
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 SUN?
DASATINIB SUN contains the active ingredient dasatinib. DASATINIB SUN
is used to treat adults and children ages 12 months and
older with chronic myeloid leukaemia (CML). It is also used to treat
adults and children ages 12 months and older who have a
particular form of acute lymphoblastic leukaemia (ALL) called
Philadelphia chromosome positive or Ph+ ALL.
For more information, see Section 1. Why am I using DASATINIB SUN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DASATINIB SUN?
Do not use if you have ever had an allergic reaction to DASATINIB SUN
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 SUN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DASATINIB SUN 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 SUN?
•
The usual starting dose for adults is 100 mg once daily (either as one
100 mg tablet or two 50 mg tablets).
•
The doctor will prescribe the starting dose for children is determined
by body weight.
More instructions can be found in Section 4. How do I use DASATINIB
SUN?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DASATINIB SUN?
THINGS YOU SHOULD DO
•
Tell all of the doctors, dentists and pharmacists who are treating you
or your child that you are
taking DASATINIB SUN.
•
Call your doctor straight away if you or your child develops a fever,
shortness of breath and
fatigue, experience bleeding or easy bruising, no matter how mild,
become pregnant while taking
DASATINIB SUN.
TH

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
DASATINIB SUN (DASATINIB) TABLETS
1
NAME OF THE MEDICINE
Dasatinib.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DASATINIB SUN film-coated tablets contain 20, 50, 70 or 100 mg of
dasatinib. Dasatinib is a white
to off-white powder.
Excipients of known effects: sugars as lactose.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DASATINIB SUN film-coated tablets.
Dasatinib 20 mg: White to off-white, biconvex, round, film-coated
tablet debossed with "851" on
one side and plain on other side.
Dasatinib 50 mg: White to off-white, biconvex, oval, film-coated
tablet debossed with "852" on one
side and plain on other side.
Dasatinib 70 mg: White to off-white, biconvex, round, film-coated
tablet debossed with "853" on
one side and plain on other side.
Dasatinib 100 mg: White to off-white, biconvex, oval, film-coated
tablet debossed with "855" on
one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DASATINIB SUN 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 SUN 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 SUN 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.
2
ADULT DOSAGE
CML
The recommended starting dosage of DAS