Tasigna

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nilotinib hydrochloride monohydrate 220.6mg equivalent to 200 mg nilotinib anhydrous free base;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Nilotinib hydrochloride monohydrate 220.6 mg (=200 mg nilotinib)

Dosage:

200 mg

Pharmaceutical form:

Capsule

Composition:

Active: Nilotinib hydrochloride monohydrate 220.6mg equivalent to 200 mg nilotinib anhydrous free base   Excipient: Colloidal silicon dioxide Crospovidone Gelatin Iron oxide yellow Lactose monohydrate Magnesium stearate Poloxamer 188 Tekprint red SW-1102 Titanium dioxide

Units in package:

Blister pack, PVC/PVDC or PA/Al/PVDC, 28 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Novartis Ringaskiddy Ltd

Therapeutic indications:

TASIGNA is indicated for the: · treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in chronic phase, · treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in adult patients resistant to or intolerant to at least one prior therapy including imatinib.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 28 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC - 40 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC - 112 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC - 120 capsules - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2006-11-20

Patient Information leaflet

TASIGNA
®
1
TASIGNA
®
_nilotinib _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tasigna.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU IF YOU ARE IN
AUSTRALIA AND MEDSAFE.GOVT.NZ IF
YOU ARE IN NEW ZEALAND.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TASIGNA IS USED
FOR
Tasigna is used to treat chronic
myeloid leukaemia (CML).
CML is a type of leukaemia in which
an abnormal chromosome produces
an enzyme that leads to uncontrolled
growth of white blood cells. Tasigna
kills the abnormal cells while leaving
normal cells alone.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Tasigna is only available with a
doctor's prescription. It is not
addictive.
There is not enough information to
recommend the use of this medicine
in children and adolescents under 18
years of age.
BEFORE YOU TAKE
TASIGNA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TASIGNA IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO
NILOTINIB (THE ACTIVE INGREDIENT) OR
TO ANY OF THE OTHER INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathi

Summary of Product characteristics

Page 1 of 35
TASIGNA
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
TASIGNA
®
150 mg and 200 mg Hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance(s)
_150 mg hard capsules _
Each capsule contains 150 mg nilotinib base (as hydrochloride,
monohydrate).
_200 mg hard capsules _
Each capsule contains 200 mg nilotinib base (as hydrochloride,
monohydrate).
Excipients with known effects
TASIGNA contains lactose and may not be suitable for patients that are
intolerant to this
ingredient (see section 4.4).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules.
_150 mg hard capsules _
White to yellowish powder in red opaque hard gelatin capsules, size 1
with black axial imprint
“NVR/BCR”.
_200 mg hard capsules _
White to slightly yellowish powder in light yellow opaque hard gelatin
capsules, size 0 with red
axial imprint “NVR/TKI”
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TASIGNA is indicated for the:
•
treatment of adult patients with newly diagnosed Philadelphia
chromosome positive
chronic myeloid leukaemia (Ph+ CML) in chronic phase,
•
treatment of chronic phase and accelerated phase Philadelphia
chromosome positive
chronic myelogenous leukaemia (CML) in adult patients resistant to or
intolerant to at
least one prior therapy including imatinib.
4.2
DOSE AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
treatment of patients with CML.
Dose
Page 2 of 35
_Dosage in patients with newly diagnosed Ph+ CML-Chronic Phase (CP) _
The recommended dose of TASIGNA is 300 mg twice daily (see section
5.2). Treatment should
be continued as long as the patient continues to benefit.
_Dosage in newly diagnosed Ph+ CML-CP patients who have achieved a
sustained deep _
_molecular response (MR 4.5) _
Discontinuation of treatment may be considered in eligible Ph+ CML-CP
patients who have
been treated with Tasigna at 300 mg twice daily for a minimum of 3
years if a deep molecular
response is sustained for a minimum of one year immediately