Deferasirox Juno deferasirox 500 mg dispersible tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

deferasirox, Quantity: 500 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, dispersible

Composition:

Excipient Ingredients: crospovidone; croscarmellose sodium; lactose monohydrate; povidone; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium lauryl sulfate

Administration route:

Oral

Units in package:

28 tablets, 84 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. Deferasirox 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 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: White to off white, round, flat, uncoated tablets, with debossing D on one side and 500 on other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-11-07

Patient Information leaflet

Deferasirox Juno Consumer Medicine Information
Deferasirox
Juno
CMI
1
DEFERASIROX JUNO
_Deferasirox _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Deferasirox Juno. 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 receiving
Deferasirox Juno against the benefits
this medicine is expected to have for you.
If you have any concerns about being given Deferasirox Juno, ask your
doctor.
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
WHAT DEFERASIROX JUNO
IS USED FOR
Deferasirox Juno 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. Deferasirox
Juno 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.
Deferasirox Juno attaches itself to the iron molecules to remove the
excess iron from the body. This will
help prevent iron-induced organ damage.
Deferasirox Juno is to be taken every day. This type of medicine must
be taken every day to help remove
the excess iron from your body.
Your doctor may have prescribed Deferasirox Juno for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE DEFERASIROX JUNO
_WHEN YOU MUST NOT TAKE IT: _
_ _
Do not take Deferasirox Juno tablets if you have an allergy to
deferasirox, the active ingredient, or to any
of the ot

Summary of Product characteristics

DEFERASIROX JUNO PI Ver 3.0
1
AUSTRALIAN PRODUCT INFORMATION
DEFERASIROX JUNO (DEFERASIROX) DISPERSIBLE TABLETS
1.
NAME OF THE MEDICINE
The active ingredient is Deferasirox.
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
Deferasirox is an orally active iron chelating agent. Deferasirox Juno
dispersible tablets for
oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox.
Excipient with known effect: Tablets contain lactose monohydrate
(16.75 mg per 125 mg
tablet, 33.50 mg per 250 mg tablet, and 67.00 mg per 500 mg tablet).
For the full list of excipients, see
SECTION 6.1 LIST OF EXIPIENTS.
3.
PHARMACEUTICAL FORM
Deferasirox Juno tablets are white to off-white, round, flat, uncoated
tablets, with debossing
“D” on one side and the dosage (“125”, “250” or “500”)
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 Juno 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 Juno 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
DOSE AND METHOD OF ADMINISTRATION
TRANSFUSIONAL IRON OVERLOAD
_DEFERASIROX JUNO DISPERSIBLE TABLETS _
It is recommended that therapy with Deferasirox Juno be started after
the transfusion of
approximately 20 units (about 100 mL/kg) of packed red blood cells or
when there is evidence
from
clinical
monitoring
that
chronic
iron
overload
is
present
(e.g.
serum
ferritin
> 1000 microgram/L). Doses (in mg/kg) must be calculated and rounded
to the nearest whole
tablet size. Deferasirox Juno is available in three tablet strengths
(125 mg, 250 mg and
500 mg). Dosing recommendations are the same for adult, paediatric and
elderly patients.
The goals of i