DASATINIB DR.REDDY'S dasatinib 100 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dasatinib propylene glycol, Quantity: 116 mg (Equivalent: dasatinib, Qty 100 mg)

Available from:

Dr Reddys Laboratories Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hydrogenated castor oil; lactose; silicon dioxide; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DASATINIB DR.REDDY'S 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 DR.REDDY'S 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 shaped tablets debossed with '603' on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-06-17

Patient Information leaflet

DASATINIB DR.REDDY’S CMI
1
DASATINIB DR.REDDY’S
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
Dasatinib Dr.Reddy’s contains the active ingredient dasatinib.
Dasatinib Dr.Reddy’s is used for the treatment of chronic myeloid
leukaemia (CML). It is also used to treat 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
Dr.Reddy’s? in the full CMI.
2. WHAT SHOULD I KNOW BEFORE I USE DASATINIB DR.REDDY’S?
Do not use if you have ever had an allergic reaction to 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
Dasatinib Dr.Reddy’s? in the full CMI.
3. WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Dasatinib Dr.Reddy’s 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 DR.REDDY’S?
•
Your doctor will decide the dose that is most appropriate for you.
Please follow your doctor's instructions about how
and when to take Dasatinib Dr.Reddy’s.
More instructions can be found in Section 4. How do I use Dasatinib
Dr.Reddy’s? in the full CMI.
5. WHAT SHOULD I KNOW WHILE USING DASATINIB DR.REDDY’S?
THINGS YOU SHOULD DO
•
Tell all doctors, dentists and pharmacists who are treating you that
you are taking Dasatinib
Dr.Reddy’s.
•
Tell your doctor if you become pregnant while taking Dasatinib
Dr.Reddy’s.
•
Tell your doctor immediately if you or your child experience bleeding
or easy bruising, no matter how
mild.
•
Have any tests recommended by your doctor done as soon as possible.
THINGS YOU SHOULD
NOT DO
•
Do not give Dasatinib Dr.Reddy’s to a

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION –
DASATINIB DR.REDDY’S
(DASATINIB)
1
NAME OF THE MEDICINE
Dasatinib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DASATINIB DR.REDDY’S film-coated tablets contain 20, 50, 70 or 100
mg of
dasatinib. Dasatinib is a white to off-white powder.
DASATINIB DR.REDDY’S film-coated tablets contain lactose. For the
full list of excipients, see Section
6.1 List of excipients.
3
PHARMACEUTICAL FORM
DASATINIB DR.REDDY’S film-coated tablets.
The 20 mg tablets are white to off-white, round tablets with “599”
debossed on one side and plain on
the other side.
The 50 mg tablets are white to off-white, oval shaped and debossed
with “600” on one side and plain on the
other side.
The 70 mg tablets are white to off-white, round tablets with “601”
debossed on one side and plain on
the other side.
The 100 mg tablets are white to off-white oval shaped and debossed
“603” on one side and plain on the other
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DASATINIB DR.REDDY’S 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 DR.REDDY’S 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 DR.REDDY’S 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.
ADULT DOSAGE
_CML_
The recommende