TASIGNA nilotinib 200 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nilotinib hydrochloride monohydrate, Quantity: 220.6 mg (Equivalent: nilotinib, Qty 200 mg)

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

nilotinib hydrochloride monohydrate

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: magnesium stearate; crospovidone; titanium dioxide; iron oxide yellow; poloxamer; Gelatin; lactose monohydrate; colloidal anhydrous silica; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; iron oxide red; ethanol absolute; potassium hydroxide; ammonia; industrial methylated spirit; iron oxide black; sulfuric acid; lecithin; xanthan gum; benzoic acid; sorbic acid; methylcellulose; polyethylene glycol; silica dimethicone silylate; dimeticone

Administration route:

Oral

Units in package:

28, 40, 120, 42, 112

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tasigna is indicated for the:,? treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (CML) in chronic phase. ? treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukaemia (CML) resistant to or intolerant of prior therapy including imatinib.

Product summary:

Visual Identification: White to slightly yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint "NVR/TKI"; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-01-17

Patient Information leaflet

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. Some children and
adolescents taking Tasigna may have
slower than normal growth.
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
reacti

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - TASIGNA

(NILOTINIB)
1.
NAME OF THE MEDICINE
Nilotinib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
TASIGNA capsules contain nilotinib (as hydrochloride, monohydrate) in
150 mg and 200 mg
strengths. Nilotinib is a white to slightly yellowish or slightly
greenish yellowish powder.
EXCIPIENTS WITH KNOWN EFFECT
TASIGNA contains lactose and may not be suitable for patients that are
intolerant to this
ingredient (see section 4.4). Tasigna capsules also contain galactose,
milk, sugars as lactose
and sulfites.
For the list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
HARD CAPSULES
TASIGNA 150 mg
White to yellowish powder in red opaque hard gelatin size 1 capsules,
with black axial imprint
NVR/BCR
TASIGNA 200 mg
White to slightly yellowish powder in light yellow opaque hard gelatin
size 0 capsules, 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 (CML) in chronic phase.
•
treatment of adults with chronic phase and accelerated phase
Philadelphia chromosome
positive chronic myeloid leukaemia (CML) resistant to or intolerant of
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
and should continue as long as the patient continues to benefit.
2
Dose
_Patients with Newly Diagnosed Ph+ CML-CP _
The recommended dose of TASIGNA is 300 mg twice daily (see section 5.2
Pharmacokinetic
Properties).
_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
prior
to
disconti