DEFERASIROX ARX deferasirox 180 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

deferasirox, Quantity: 180 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; poloxamer; sodium starch glycollate type A; microcrystalline cellulose; colloidal anhydrous silica; crospovidone; magnesium stearate; titanium dioxide; indigo carmine aluminium lake; hypromellose; macrogol 4000; purified talc

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. DEFERASIROX AGH is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective. ,DEFERASIROX AGH is also indicated for the treatment of chronic iron overload in patients with non-transfusion- dependent thalassemia syndromes aged 10 years and older.

Product summary:

Visual Identification: Medium blue, oval, biconvex, film-coated tablet with beveled edges, debossed with "L" on one side and "664" on the other side. Approximately 13 mm in length and approximately 5 mm in width.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-11-16

Patient Information leaflet

DEFERASIROX ARX
1
DEFERASIROX ARX
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 DEFERASIROX ARX?
Deferasirox ARX contains the active ingredient Deferasirox.
Deferasirox ARX is used to treat a condition called iron overload,
which happens when the body has too much iron. This can occur after
repeated blood transfusions.
For more information, see Section 1. Why am I using Deferasirox ARX?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DEFERASIROX ARX?
Do not use if you have ever had an allergic reaction to Deferasirox
ARXor 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
Deferasirox ARX?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Deferasirox ARX 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 DEFERASIROX ARX?
The dose of DEFERASIROX ARX is related to body weight for all
patients. Your doctor will calculate the dose you need and tell
you how many tablets to take each day.
The usual starting dose is 14 mg per kilogram body weight each day for
patients receiving regular blood transfusions.
More instructions can be found in Section 4. How do I use Deferasirox
ARX? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DEFERASIROX ARX?
THINGS YOU
SHOULD DO
If you notice substantially reduced urine output, tell your doctor
straight away.
If you become pregnant while taking this medicine, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
Do not give this medicine to anyone else, even if their condition
seems similar to yours.
Do not use it to treat any other complaints unless your doctor tells
you to.
DRIVING OR US

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – DEFERASIROX ARX
(DEFERASIROX) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Deferasirox
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DEFERASIROX ARX 90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
DEFERASIROX ARX 180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
DEFERASIROX ARX 360 mg film-coated tablets
Each film-coated tablet contains 360 mg deferasirox.
Deferasirox is a white to slightly yellow powder and is a non-chiral
compound. At the physiological pH of the
intestine, the solubility is about 40 mg/L. The API is practically
insoluble in water and across the pH range
1.2 – 6.00, and soluble at pH 8.00.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet.
90 MG:
Light blue, oval, biconvex, film-coated tablet with beveled edges,
debossed with “L” on one side and
“663” on the other side. Approximately 10 mm in length and
approximately 4 mm in width.
180 MG:
Medium blue, oval, biconvex, film-coated tablet with beveled edges,
debossed with “L” on one side
and “664” on the other side. Approximately 13 mm in length and
approximately 5 mm in width.
360 MG:
Dark blue, oval, biconvex, film-coated tablet with beveled edges,
debossed with “L” on one side and
“665” on the other side. Approximately 17 mm in length and
approximately 7 mm in width.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
The treatment of chronic iron overload due to blood transfusions
(transfusional haemosiderosis) in adults and
paediatric patients 6 years and older. DEFERASIROX ARX is also
indicated for the treatment of chronic iron
overload in paediatric patients aged 2 to 5 years who are unable to
take desferrioxamine therapy or in whom
desferrioxamine has proven ineffective.
DEFERASIROX ARX is also indicated for the treatment of chronic iron
overload in patients with non-
transfusion- dependent thalassemia syndromes aged 10 years and older.
4.2
D
OSE AND METHOD OF ADMI