GLIVANIB imatinib (as mesilate) 400 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

imatinib mesilate

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

imatinib mesilate

Authorization status:

Registered

Patient Information leaflet

Glivanib 100 mg & 400 mg capsules
Page 1 of 10
V2-1016
GLIVANIB
_Imatinib (as imatinib mesilate) capsules_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
GLIVANIB capsules.
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.
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 GLIVANIB
CAPSULES ARE USED
FOR
GLIVANIB is used to treat
adults who have chronic
myeloid leukaemia (CML)
and 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. GLIVANIB kills the
abnormal cells while
leaving normal cells alone.
GLIVANIB 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.
•
AGGRESSIVE SYSTEMIC
MASTOCYTOSIS (ASM).
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.
•
DERMATOFIBROSARCOMA
PROTUBERANS (DFSP).
DFSP is a cancer of the
tissue beneath the skin in
which some

Summary of Product characteristics

Glivanib PI Juno Pharmaceuticals Pty Ltd
Doc ID: 143.GL.P.1.0 Page 1 of 47
GLIVANIB
IMATINIB( AS MESILATE)
capsules
PRODUCT INFORMATION
NAME OF THE MEDICINE
AUSTRALIAN-APPROVED-NAME
Active ingredient:
imatinib as the mesilate salt. (alpha crystals)
Chemical name:
4‐[(4‐Methylpiperazin‐1‐yl)methyl]‐N‐[4‐methyl‐3‐[[4‐
(pyridin‐3‐yl)
pyrimidin‐2‐yl]amino]phenyl]benzamide methanesulfonate
Molecular formula:
C
29
H
31
N
7
O . CH
4
SO
3
CAS NUMBER
:
152459-95-5 (free base); 220127-57-1 (mesilate)
Molecular weight:
493.6 (free base) + 96.1 (mesilate) = 589.7
STRUCTURAL FORMULA
:
C
H
3
N
C
H
3
H
N
N
N
N
H
N
N
O
.
CH
3
SO
3
H
DESCRIPTION
Imatinib mesilate is a white to slightly yellowish powder. It is
freely soluble in water
and aqueous buffers
≤
pH 5.5 and less soluble in more neutral/alkaline aqueous
buffers. In non- aqueous solvents, the compound is soluble in dimethyl
sulfoxide,
methanol and ethanol, but is insoluble in n-octanol, acetone and
acetonitrile.
Each hard gelatin capsule contains
100 MG
or
400 MG
of imatinib (equivalent to 119.50
or 478mg imatinib mesilate, respectively).
Glivanib PI Juno Pharmaceuticals Pty Ltd
Doc ID: 143.GL.P.1.0 Page 2 of 47
EXCIPIENTS:
Lactose anhydrous, crospovidone, colloidal anhydrous silica and
magnesium stearate.
Capsule cap and body contains gelatin, water- purified, iron oxide red
(CI 77491), iron
oxide yellow (CI 77492), titanium dioxide (CI 77891) and sodium lauryl
sulfate.
Since there is no lower dose (50 mg) of GLIVANIB capsules currently
available, if a
50 mg dose of imatinib is
required, an alternative product must be used.
PHARMACOLOGY
ATC CODE
Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATC
code: L01XE01
MECHANISM OF ACTION
Imatinib is a small molecule protein-tyrosine kinase inhibitor that
potently inhibits the
activity of the BCR-ABL tyrosine kinase (TK), as well as several
receptor TKs: KIT,
the receptor for stem cell factor (SCF) coded for by the KIT
proto-oncogene, the
discoidin domain receptors (DDR1) and DDR2), the c