IMATINIB GH imatinib (as mesilate) 400 mg capsules 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:

Cipla Australia Pty Ltd

INN (International Name):

imatinib mesilate

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: magnesium stearate; lactose; colloidal anhydrous silica; crospovidone; titanium dioxide; purified water; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

96, 48, 30, 24, 120, 180

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

IMATINIB GH is indicated for the: ? treatment of patients with chronic myeloid leukaemia (CML) ? 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, 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) ? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Product summary:

Visual Identification: Light yellow granules filled in size 00EL hard gelatin capsules with brown cap and brown body.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-12-22

Patient Information leaflet

Imatinib GH
1
IMATINIB GH
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 IMATINIB GH?
Imatinib GH contains the active ingredient imatinib mesilate. Imatinib
GH is used to treat adults who have chronic myeloid
leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia
chromosome positive (Ph-positive ALL).
Imatinib GH is also used to treat adults for
myelodysplastic/myeloproliferative diseases (MDS/MPD), aggressive
systemic
mastocytosis (ASM), hypereosinophilic syndrome (HES) and or chronic
eosinophilic leukaemia (CEL) and for
dermatofibrosarcoma protuberans (DFSP). For more information, see
Section 1. Why am I using Imatinib GH? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IMATINIB GH?
Do not use if you have ever had an allergic reaction to Imatinib GH 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
Imatinib GH? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Imatinib GH 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 IMATINIB GH?
For CML, the usual dose for an adult is 400 to 600 mg each day. For
Ph-positive ALL the usual dose is 600 mg each day. For
MDS/MPD, the starting dose is 400 mg. For ASM and HES/CEL, the usual
starting dose is 400 mg. For some patients, the
starting dose may be 100 mg. For DFSP, the starting dose is 800 mg per
day.
More instructions can be found in Section 4. How do I use Imatinib GH?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IMATINIB GH?
THINGS YOU
SHOULD DO
• Remind any doctor, dentist or pharmacist when you visit that you
are using Imatinib GH.
• You will ne

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - IMATINIB GH (IMATINIB CAPSULES)
1
NAME OF THE MEDICINE
Imatinib capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains 100 mg or 400 mg of imatinib
(equivalent to 119.50 mg or
478 mg imatinib mesilate, respectively).
Excipients with known effects
Each 100 mg capsule contains 39.91 mg of lactose
Each 400 mg capsule contains 159.64 mg of lactose
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Capsule
IMATINIB GH 100 MG CAPSULE
:
Light yellow granules filled in size 3 hard gelatin capsule with brown
cap and white body.
I
MATINIB GH 400 MG CAPSULE:
Light yellow granules filled in size 00EL hard gelatin capsule with
brown cap and brown body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IMATINIB GH is indicated for the:
•
treatment of patients with chronic myeloid leukaemia (CML).
•
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, 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).
4.2