JADENU 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:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 film-coated tablets

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. JADENU 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. JADENU 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 unscored ovaloid biconvex film-coated tablet with bevelled edges, debossed with NVR on one side and 180 on a slight upward slope in between two debossed curved lines on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-03-15

Patient Information leaflet

JADENU
®
_deferasirox_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about JADENU.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT JADENU IS USED
FOR
JADENU 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.
The body has no natural way to
remove excess iron which comes
with blood transfusions.
JADENU is also used to treat
patients who have iron overload
associated with their thalassemia
syndromes, but who are not
transfusion dependent. In patients
with non-transfusion-dependent
thalassemia syndromes, iron overload
may develop over time due to
increased absorption of dietary iron
in response to low blood cell counts.
Over time, this excess iron can
damage important organs such as the
liver and heart.
This medicine contains an active
substance called deferasirox. It
attaches itself to the iron molecules
to remove the excess iron from the
body. This will help prevent iron-
induced organ damage.
JADENU IS TO BE TAKEN EVERY DAY.
This type of medicine must be taken
every day to help remove the excess
iron from your body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABO

Summary of Product characteristics

1
AUSTRALIAN PI – JADENU (DEFERASIROX) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Deferasirox.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
JADENU 90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
JADENU 180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
JADENU 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.
3
PHARMACEUTICAL FORM
Film-coated tablet.
90 mg: Light blue unscored ovaloid biconvex film-coated tablet with
bevelled edges, debossed with
‘NVR’ on one side and ‘90’ on a slight upward slope in between
two debossed curved lines on the
other side.
180 mg: Medium blue unscored ovaloid biconvex film-coated tablet with
bevelled edges, debossed
with ‘NVR’ on one side and ‘180’ on a slight upward slope in
between two debossed curved lines on
the other side.
360 mg: Dark blue unscored ovaloid biconvex film-coated tablet with
bevelled edges, debossed with
‘NVR’ on one side and ‘360’ on a slight upward slope in
between two debossed curved lines on the
other side.
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. JADENU 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.
JADENU is also indicated for the treatment of chronic iron overload in
patients with non-transfusion-
dependent thalassemia syndromes aged 10 years and older.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSE
TRANSFUSIONAL IRON OVERLOAD (JADENU FILM-COATED TABLETS)_ _
It is recommended that therapy with JADENU be started after the
transfusion of appro