GILMAT imatinib (as mesilate) 400 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

imatinib mesilate, Quantity: 478 mg (Equivalent: imatinib, Qty 400 mg)

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc

Administration route:

Oral

Units in package:

30 film-coated tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Gilmat is indicated for the:,? treatment of patients with chronic myeloid leukaemia (CML) ? treatment of adult and paediatric 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, where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) ?treatment of patients with KIT (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) ?adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of KIT (CD117)-positive primary GIST (see Dosage and Administration and Clinical Trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Product summary:

Visual Identification: White to off-white coloured capsule shaped bevel edged scored film coated tablet debossed with H on one side and 20 on the other side, 2 and 0 separated by a score line.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-11-14

Patient Information leaflet

Gilmat® (V – 03)
1
GILMAT®
imatinib mesilate
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING GILMAT?
Gilmat contains the active ingredient imatinib mesilate. Gilmat is
used to treat adults and children/adolescents who have
chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with
Philadelphia chromosome positive (Ph-positive
ALL). Gilmat is also used to treat adults for: myelodysplastic
/myeloproliferative diseases (MDS/MPD); Hypereosinophilic
syndrome (HES) and or chronic eosinophilic leukaemia (CEL);
gastro-intestinal stromal tumours (GIST); dermatofibrosarcoma
protuberans (DFSP).
For more information, see Section 1. Why am I using Gilmat? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GILMAT?
Do not use if you have ever had an allergic reaction to imatinib or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Gilmat? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Gilmat and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE GILMAT?
Follow all directions given to you by your doctor and pharmacist
carefully.
More instructions can be found in Section 4. How do I use Gilmat? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GILMAT?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
Gilmat.
-
Make sure you follow your doctor's instructions carefully and keep all
appointments.
-
Make sure you use a method of contraception to prevent pregnancy
during treatment with Gilmat and
for 15 days after ending treatment.
-
Tell your doctor immediately if you become pregnant while

Summary of Product characteristics

Gilmat (V – 03)
Page 1 of 54
AUSTRALIAN PRODUCT INFORMATION
GILMAT (IMATINIB) TABLETS
1
NAME OF THE MEDICINE
Imatinib as the mesilate salt (alpha crystals).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg or 400 mg of imatinib
(equivalent to 119.5 mg or 478 mg
imatinib mesilate, respectively).
Excipients with known effect: none
For the full list of excipients, see Section 6.1 List of Excipients
3
PHARMACEUTICAL FORM
Gilmat 100 mg film-coated tablet: contains 100 mg imatinib (as
mesilate) in a white to off-white
coloured, round, bevel edged scored tablets debossed with H on one
side and 19 on the other
side, 1 and 9 separated by a score line.
Gilmat 400 mg film-coated tablet: contains 400 mg imatinib (as
mesilate) in a white to off-white
coloured, capsule shaped, bevel edged scored, film coated tablets
debossed with H on one side
and 20 on the other side, 2 and 0 separated by a score line.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gilmat is indicated for the:
•
treatment of patients with chronic myeloid leukaemia (CML)
•
treatment of adult and paediatric 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,
where conventional therapies have failed
•
treatment
of
adult
patients
with
hypereosinophilic
syndrome
(HES)
and/or
chronic
eosinophilic leukaemia (CEL)
•
treatment of patients with KIT (CD117) positive unresectable and/or
metastatic malignant
gastrointestinal stromal tumours (GIST)
Gilmat (V – 03)
Page 2 of 54
•
adjuvant treatment of adult patients at high risk of recurrence
following complete gross
resection of KIT (CD117)-positive primary GIST (see Dosage and
Administration and Clinical
Trials)
•
treatment
of
adult
pa