CIPLA IMATINIB ADULT imatinib (as mesilate) 100 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

imatinib mesilate, Quantity: 119.5 mg (Equivalent: imatinib, Qty 100 mg)

Available from:

Cipla Australia Pty Ltd

INN (International Name):

imatinib mesilate

Pharmaceutical form:

Capsule

Composition:

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

Administration route:

Oral

Units in package:

60, 120, 180, 24, 48, 96

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

? 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 3 hard gelatin capsule with brown cap and white 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:

2016-05-20

Patient Information leaflet

Cipla Imatinib Adult
1
CIPLA IMATINIB ADULT
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 CIPLA IMATINIB ADULT?
Cipla Imatinib Adult contains the active ingredient imatinib mesilate.
Cipla Imatinib Adult is used to treat adults who have
chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with
Philadelphia chromosome positive (Ph-positive
ALL).
Cipla Imatinib Adult 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 Cipla Imatinib Adult? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA IMATINIB ADULT?
Do not use if you have ever had an allergic reaction to Cipla Imatinib
Adult 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 Cipla Imatinib
Adult? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Imatinib Adult 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 CIPLA IMATINIB ADULT?
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 Cipla
Imatinib Adult? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIPLA IMATINIB ADULT?
TH

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - CIPLA IMATINIB ADULT (IMATINIB
CAPSULES)
1
NAME OF THE MEDICINE
Australian approved name: imatinib mesilate.
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
CIPLA IMATINIB ADULT 100 MG CAPSULE
:
Light yellow granules filled in size 3 hard gelatin capsule with brown
cap and white body.
CIPLA IMATINIB ADULT 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
CIPLA IMATINIB ADULT 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