ARX-IMATINIB imatinib (as mesilate) 100mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

imatinib mesilate, Quantity: 119.47 mg (Equivalent: imatinib, Qty 100 mg)

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

imatinib mesilate

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: purified water; Gelatin; crospovidone; titanium dioxide; iron oxide yellow; sodium lauryl sulfate; sodium stearylfumarate; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; Shellac; ethanol absolute; ammonia

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ? 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)

Product summary:

Visual Identification: orange to grayish-orange opaque Size '1' hard gelatin capsule imprinted with "RDY" on cap and "100" on body with red ink.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-08-11

Patient Information leaflet

IMATINIB APOTEX
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 APOTEX?
IMATINIB APOTEX contains the active ingredient imatinib. IMATINIB
APOTEX is used to treat leukaemia and some other forms
of cancer.
For more information, see Section 1. Why am I using IMATINIB APOTEX?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IMATINIB APOTEX?
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
IMATINIB APOTEX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with IMATINIB APOTEX 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 APOTEX?
•
Your doctor will advise on the appropriate dose for your condition.
•
IMATINIB APOTEX is usually taken as a single dose each day, although
twice daily dosing may be recommended by your
doctor
•
Take IMATINIB APOTEX with food and a large glass of water
•
Capsules should be taken whole. If you have trouble swallowing,
capsules may be opened and poured into a glass of
water or apple juice and swallowed.
More instructions can be found in Section 4. How do I use IMATINIB
APOTEX? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IMATINIB APOTEX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
IMATINIB APOTEX.
•
Follow your doctor’s instructions carefully and keep all
appointments to ensure your treatment is
working.
•
Make sure you use a method of contraception to prevent pregnancy
during treatment and for 15
days after ending treatment. Advise your doctor if y

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – IMATINIB APOTEX
(IMATINIB MESILATE) CAPSULES
1
NAME OF THE MEDICINE
Imatinib (as mesilate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatine capsule contains 50mg, 100 mg or 400 mg of imatinib
(equivalent to 59.7mg,
119.5 mg or 478 mg imatinib mesilate, respectively).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
IMATINIB APOTEX 50 mg capsules are off-white to brownish yellow colour
granular powder filled
in light yellow to orange yellow opaque Size ‘4’ Hard Gelatin
capsule imprinted with ‘RDY’ on cap
and ‘50’ on body with red ink.
IMATINIB APOTEX 100 mg capsules are off-white to brownish yellow
colour granular powder
filled in orange to grayish-orange opaque Size ‘1’ Hard Gelatin
capsule imprinted with ‘RDY’ on cap
and ‘100’ on body with red ink.
IMATINIB APOTEX 400 mg capsules are off-white to brownish yellow color
granular powder filled
in very dark yellow to brownish-orange opaque Size '00' Hard Gelatin
capsule imprinted with
'RDY' on cap and '400' on body with red ink.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
IMATINIB APOTEX 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 mali