Glivec

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Imatinib mesilate 59.75mg Equivalent to 50 mg imatinib base

Available from:

Novartis New Zealand Ltd

INN (International Name):

Imatinib mesilate 59.75 mg (Equivalent to 50 mg imatinib base)

Dosage:

50 mg

Pharmaceutical form:

Capsule

Composition:

Active: Imatinib mesilate 59.75mg Equivalent to 50 mg imatinib base Excipient: Colloidal silicon dioxide Crospovidone Gelatin Iron oxide yellow Magnesium stearate Microcrystalline cellulose Titanium dioxide

Units in package:

Blister pack, PVC or PVC/PE/PVDC, 30 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Novartis Ringaskiddy Ltd

Therapeutic indications:

· Treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+CML). · Treatment of adult and paediatic patients with Ph+CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · Treatment of adult patients with new diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) integrated with chemotherapy. · Treatment of adult patients with relapsed or refractory Ph+ALL as monotherapy. · Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. · Treatment of adult patients with systemic mastocytosis (SM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. · Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). · Treatment of adult patients with Kit+ (CD117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). · Adjuvant treatment of adult patients following resection of Kit+GIST. · Treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC or PVC/PE/PVDC - 30 capsules - 24 months from date of manufacture stored at or below 30°C

Authorization date:

2001-03-12

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
Novartis New Zealand Limited
Page 1
GLIVEC
®
_imatinib _
_ _
_100mg tablets _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Glivec.
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.medsafe.govt.nz
.
Those updates
may contain important information about the medicine and its use of
which you should be aware.
It does not contain all the available information. It does not take
the place of talking to your doctor or pharmacist.
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 GLIVEC IS USED FOR

Glivec is used to treat adults and children who have chronic myeloid
leukaemia (CML) and adults with acute
lymphoblastic leukaemia with Philadelphia chromosome positive
(Ph-positive ALL).
CML and ALL are types of leukaemia in which an abnormal chromosome
produces an enzyme that leads to
uncontrolled growth of white blood cells. Glivec kills the abnormal
cells while leaving normal cells alone.
Glivec is also used to treat adults for:

MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD).
These are a group of blood diseases in which
some blood cells start growing out of control.

SYSTEMIC MASTOCYTOSIS (SM).
It is a cancer in which certain blood cells, called “mast” cells,
grow out of
control.

HYPEREOSINOPHILIC SYNDROME (HES) AND OR CHRONIC EOSINOPHILIC LEUKAEMIA
(CEL).
These are blood
diseases in which some blood cells, named “eosinophils”, start
growing out of control.

GASTRO-INTESTINAL STROMAL TUMOURS (GIST).
This is a typ

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1
1
PRODUCT NAME
GLIVEC

100 and 400* mg film-coated tablets
GLIVEC

50 and 100 mg hard capsules*
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S)
FILM-COATED TABLETS
Each tablet contains 100 or 400* mg imatinib mesilate (beta crystals).
HARD CAPSULES*
Each capsule contains 50 or 100 mg imatinib mesilate (beta crystals).
For the full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Hard capsules*
100 MG TABLETS, DIVISIBLE
Very dark yellow to brownish orange film-coated tablets, biconvex with
debossed “NVR” on
one side and “SA” and score on the other side.
400 MG TABLETS, NOT DIVISIBLE*
Very dark yellow to brownish orange, ovaloid, biconvex with bevelled
edges. Debossed with
“NVR” on one side and “SL” on the other side.
50 MG CAPSULES*
White to yellow powder in a light yellow to orange-yellow opaque
capsule, marked “NVR SH”.
100 MG CAPSULES*
White to yellow powder in an orange to greyish-orange opaque capsule,
marked “NVR SI”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glivec
®
is indicated for the
2
•
treatment of adult and paediatric patients with newly diagnosed
Philadelphia chromosome
positive chronic myeloid leukaemia (Ph+CML) (for paediatric use see
section 4.2 Posology
and method of administration).
•
treatment of adult and paediatric patients with Ph+CML in blast
crisis, accelerated phase,
or in chronic phase after failure of interferon-alpha therapy
]
(for paediatric use see section
4.2 Posology and method of administration).
•
treatment of adult patients with newly diagnosed Philadelphia
chromosome positive acute
lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
•
treatment of adult patients with relapsed or refractory Ph+ ALL as
monotherapy.
•
treatment of adult patients with myelodysplastic/myeloproliferative
diseases (MDS/MPD)
associated with platelet-derived growth factor receptor (PDGFR) gene
re-arrangements.
•
treatment of adult patients with systemic mastocytosis (