DEFERASIROX-TEVA deferasirox 90 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

deferasirox, Quantity: 90 mg

Available from:

Teva Pharma Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

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-TEVA 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-TEVA 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: Light blue, ovaloid, biconvex, film-coated tablets with bevelled edges,,debossed with 90 on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-08-24

Patient Information leaflet

DEFERASIROX-TEVA
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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-TEVA?
DEFERASIROX-TEVA contains the active ingredient deferasirox.
DEFERASIROX-TEVA 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-TEVA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DEFERASIROX-TEVA?
Do not use if you have ever had an allergic reaction to
DEFERASIROX-TEVA 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
DEFERASIROX-TEVA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DEFERASIROX-TEVA 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-TEVA?
•
Follow all directions given to you by your doctor or pharmacist
carefully.
•
The dose of DEFERASIROX-TEVA 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.
More instructions can be found in Section 4. How do I use
DEFERASIROX-TEVA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DEFERASIROX-TEVA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
DEFERASIROX-TEVA.
•
Tell your doctor immediately if you notice substantially reduced urine
output.
•
Tell your doctor if you are pregnant or intend to become pregnant
while taking this medicine.
•
Keep all of your doctor's appointments so that your progress can be
checked.
•
Eld

Summary of Product characteristics

Teva Pharma Australia Pty Ltd
Version 1.0
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AUSTRALIAN PRODUCT INFORMATION – DEFERASIROX-TEVA
(DEFERASIROX) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Deferasirox.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DEFERASIROX-TEVA 90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
DEFERASIROX-TEVA 180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
DEFERASIROX-TEVA 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.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Film-coated tablet.
90 mg: Light blue unscored ovaloid biconvex film-coated tablet with
bevelled edges, debossed with
‘90’ on one side and plain on the other side.
180 mg: Medium blue unscored ovaloid biconvex film-coated tablet with
bevelled edges, debossed
with ‘180’ on one side and plain on the other side.
360 mg: Dark blue unscored ovaloid biconvex film-coated tablet with
bevelled edges, debossed with
‘360’ on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment of chronic iron overload due to blood transfusions
(transfusional haemosiderosis) in
adults and paediatric patients 6 years and older. DEFERASIROX-TEVA 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-TEVA is also indicated for the treatment of chronic iron
overload in patients with
non-transfusion-dependent thalassemia syndromes aged 10 years and
older.
Teva Pharma Australia Pty Ltd
Version 1.0
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
TRANSFUSIONAL IRON OVERLOAD (DEFERASIROX-TEVA FILM-COATED TABLETS)
It is recommended that therapy with DEFERASIROX-TEVA be started after
the transfusion of
approximat