Tasigna 50mg Capsules

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

NILOTINIB HYDROCHLORIDE MONOHYDRATE

Disponible depuis:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

DCI (Dénomination commune internationale):

NILOTINIB HYDROCHLORIDE MONOHYDRATE

Unités en paquet:

120 Capsules

Fabriqué par:

NOVARTIS PHARMA STEIN AG

Notice patient

_Consumer Medication Information Leaflet (RiMUP) _
TASIGNA
®
NILOTINIB
50MG, 150MG AND 200MG HARD CAPSULES
1
WHAT IS IN THIS LEAFLET
1.
WHAT TASIGNA IS USED FOR
2.
HOW TASIGNA WORKS
3.
BEFORE YOU USE TASIGNA
4.
HOW TO USE TASIGNA
5.
WHILE YOU ARE USING TASIGNA
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF TASIGNA
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT TASIGNA IS USED FOR
Tasigna is used to treat a type of
leukaemia called Philadelphia
chromosome positive chronic myeloid
leukaemia (Ph-positive CML). CML is a
cancer of the blood which makes the body
produce too many abnormal white blood
cells.
Tasigna is used in adult and paediatric
patients with newly diagnosed CML or in
patients with CML who are no longer
benefiting from previous treatment
including imatinib. It is also used in adult
and paediatric patients who experienced
serious side effects with previous
treatment and are not able to continue
taking it.
HOW TASIGNA WORKS
In patients with CML, a change in DNA
(genetic material) triggers a signal that
tells the body to produce abnormal white
blood cells. Tasigna blocks this signal,
and thus stops the production of these
cells.
_MONITORING DURING TASIGNA _
_TREATMENT_
_ _
Regular tests, including blood tests, will
be performed during treatment. These
tests will monitor:
-
the amount of blood cells (white blood
cells, red blood cells and platelets) in
your body to see how Tasigna is
tolerated.
-
pancreas and liver function in the
body to see how Tasigna is tolerated.
-
the electrolytes in the body
(potassium, magnesium). These are
important in the functioning of the
heart.
-
the level of sugar and fats in the blood.
The heart rate will also be checked using
a machine that measures electrical
activity of the heart (a test called an
“ECG”).
Your doctor will regularly evaluate your
treatment and decide whether you should
continue to take Tasigna. If you are told
to discontinue this medicine, your doctor
will continue to monitor your CML and
may tell you to r

Résumé des caractéristiques du produit

Novartis
Page 2
Malaysia Package Insert
18-May-2020
Tasigna
2
1.
NAME OF THE MEDICINAL PRODUCT
Tasigna 50 mg hard capsules
Tasigna 150 mg hard capsules
Tasigna 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tasigna 50 mg hard capsules
One hard capsule contains 50 mg nilotinib (as hydrochloride
monohydrate).
_Excipient with known effect _
One hard capsule contains 39.03 mg lactose monohydrate.
Tasigna 150mg hard capsules
One hard capsule contains 150 mg nilotinib (as hydrochloride
monohydrate).
_Excipient with known effect _
One hard capsule contains 117.08 mg lactose monohydrate.
Tasigna 200 mg hard capsules
One hard capsule contains 200 mg nilotinib (as hydrochloride
monohydrate).
_Excipient with known effect _
One hard capsule contains 156.11 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Tasigna 50 mg hard capsules
White to yellowish powder in hard gelatin capsule with red opaque cap
and light yellow
opaque body, size
4 with black radial imprint “NVR/ABL” on cap.
Tasigna 150 mg hard capsules
White to yellowish powder in red opaque hard gelatin capsules, size 1
with black axial
imprint “NVR/BCR”.
Novartis
Page 3
Malaysia Package Insert
18-May-2020
Tasigna
3
Tasigna 200 mg hard capsules
White to 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 leukemia (Ph+ CML) in chronic phase (CP).
Clinical effectiveness of TASIGNA in adults with newly diagnosed Ph+
CML-CP is
based on major molecular response rate at 12 months and complete
cytogenetic
response rate by 12 months.
•
the treatment of pediatric patients 2 years of age and older with
newly diagnosed Ph+
CML-CP.
Clinical effectiveness of TASIGNA in pediatric patients with newly
diagnosed Ph+
CML-CP is based on major molecular response b