GLIVEC imatinib 400mg tablet divisible blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; crospovidone; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; iron oxide red; macrogol 4000; iron oxide yellow

Administration route:

Oral

Units in package:

30 Tablets, 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GLIVEC 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 aggressive systemic mastocytosis (ASM) 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: Very dark yellow to brownish orange, ovaloid biconvex with bevelled edges. Debossed with "400" on one side and score on the other and "SL" on each side of the score.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2003-12-17

Patient Information leaflet

GLIVEC
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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 GLIVEC?
Glivec contains the active ingredient imatinib. Glivec is used to
Glivec is used to treat children and adults who have certain types of
cancer and leukemia.
For more information, see Section 1. Why am I using Glivec? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GLIVEC?
Do not use if you have ever had an allergic reaction to Glivec 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
Glivec? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Glivec 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 GLIVEC?
•
Your doctor will tell you exactly how many tablets of Glivec to take
•
Follow the instructions provided and use Glivec until your doctor
tells you to stop
More instructions can be found in Section 4. How do I use Glivec? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GLIVEC?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Glivec.
•
Have regular check-ups to make sure the treatment is working
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly (unless your doctor tells you
to)
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Glivec affects you
DRINKING
ALCOHOL
•
There are no known interactions between Glivec and alcohol
LOOKING AFTER
YOUR MEDICINE
•
Store it in a cool dry place away from moisture, heat or sunlight
•
Keep out of reach of children
For more information, see Section 5. W

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
GLIVEC (IMATINIB) CAPSULES & FILM-COATED TABLETS
1
NAME OF THE MEDICINE
The active ingredient is imatinib as the mesilate salt (beta
crystals).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains 100 mg of imatinib (equivalent to
119.5 mg imatinib mesilate).
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
Glivec capsules contain sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Glivec 100 mg capsule: orange to grayish-orange opaque hard gelatin
capsule, marked “NVR SI”.
Glivec 100 mg film-coated tablet: very dark yellow to brownish orange
round tablet with imprint
“NVR” on one side and “SA” and score on the other side.
Glivec 400 mg film-coated tablet: very dark yellow to brownish orange,
ovaloid, biconvex tablet
with “400” on one side and score on the other side and “SL” on
each side of the score.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Glivec 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 aggressive systemic mastocytosis
(ASM), where
conventional therapies have failed
•
treatment of adult patients with hypereosinophilic syndrome (HES)
and/or chronic
eosinophilic leukaemia (CEL)
2
•
treatment of patients with KIT (CD117) positive unresectable and/or
metastatic
malignant gastrointestinal stromal tumours (GIST)
•
adjuvant t