Imatinib-DRLA 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: crospovidone; sodium stearylfumarate; Gelatin; titanium dioxide; purified water; iron oxide yellow; sodium lauryl sulfate; 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-DRLA
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-DRLA?
IMATINIB-DRLA contains the active ingredient imatinib. IMATINIB-DRLA
is used to treat leukaemia and some other forms of
cancer.
For more information, see Section 1. Why am I using IMATINIB-DRLA? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IMATINIB-DRLA?
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-DRLA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with IMATINIB-DRLA 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-DRLA?
•
Your doctor will advise on the appropriate dose for your condition.
•
IMATINIB-DRLA is usually taken as a single dose each day, although
twice daily dosing may be recommended by your
doctor
•
Take IMATINIB-DRLA 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-DRLA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IMATINIB-DRLA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
IMATINIB-DRLA.
•
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 you become
pregnant.
•
Wear

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – IMATINIB-DRLA (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-DRLA 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-DRLA 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-DRLA 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-DRLA 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
gast