Irosix 180mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

DEFERASIROX

Boleh didapati daripada:

NOVUGEN PHARMA SDN. BHD.

INN (Nama Antarabangsa):

DEFERASIROX

Unit dalam pakej:

30 Tablets; 3 x 10 Tablets; 1 x 10 Tablets; 10 x 10 Tablets; 50 x 10 Tablets; 100 x 10 Tablets; 6 x 10 Tablets

Dikeluarkan oleh:

NOVUGEN PHARMA SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
IROSIX FILM COATED TABLETS
DEFERASIROX
90 mg, 180 mg and 360 mg Film Coated Tablets
WHAT IS IN THIS LEAFLET
1.
WHAT IROSIX IS USED FOR
2.
HOW IROSIX WORKS
3.
BEFORE YOU USE IROSIX
4.
HOW TO USE IROSIX
5.
WHILE YOU ARE USING
IROSIX
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
IROSIX
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
WHAT IROSIX IS USED FOR
Irosix 90 mg, 180 mg and 360 mg
Film Coated Tablets contains an
active substance called
deferasirox. This medicine is an
iron chelator which removes the
excess iron from the body (also
called iron overload).
•
Transfusional iron overload
(excess amount of iron in
patients receiving regular
blood transfusions)
Irosix is used to treat iron
overload caused by repeated
blood transfusions. It can be used
to treat adults, adolescents, and
children aged 2 years and above.
Repeated blood transfusions may
be necessary in patients suffering
from certain types of anemia such
as thalassemia, sickle cell disease
or myelodysplastic syndromes.
However, repeated blood
transfusions can cause a build-up
of excess iron. This is because
blood contains iron and your body
does not have a natural way to
remove the excess iron you get
with your blood transfusions.
•
Non-transfusion-dependent
thalassemia syndromes (
excess amount of iron in
patients with thalassemia not
receiving regular blood
transfusions)
Irosix is used to treat patients
who have iron overload
associated with their thalassemia
syndromes, but who are not
transfusion dependent. In this
case, it can be used to treat adults,
adolescents, and children aged 10
years and above. 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. In thalassemic
patients not receiving regular
blood transfusions, increased iron
levels are usually only observed
in patients 10 years of age and
above.
Over

Ciri produk

DEF-T/S0/PI/L1/M1-04
*Packed Red Blood Cells
** Dose conversion explained in more detail in Table 3
NON-TRANSFUSION-DEPENDENT THALASSEMIA (NTDT) SYNDROMES
DOSAGE
Chelation therapy should only be initiated when there is evidence of
iron overload (liver iron concentration (LIC) ≥5 mg
Fe/g dry weight (dw) or serum ferritin consistently >800 µg/L). In
patients with no LIC assessment, caution should be
taken during chelation therapy to minimize the risk of overchelation.
Irosix Film Coated Tablets are strength-adjusted formulation of
Deferasirox with higher bioavailability compared to the
Deferasirox dispersible tablets formulation. For patients who are
currently on chelation therapy with Deferasirox
dispersible tablets and switching to Irosix Film Coated Tablets, the
dose of Irosix Film Coated Tablets should be 30%
lower than the dose of Deferasirox dispersible tablets, rounded to the
nearest whole tablet.
STARTING DOSE
The recommended initial daily dose of Irosix Film Coated Tablets is 7
mg/kg body weight.
DOSE ADJUSTMENT
It is recommended that serum ferritin be monitored every month to
assess the patient’s response to therapy and to
minimize the risk of overchelation (see section Special warnings and
precautions for use). Every 3 to 6 months of
treatment, consider a dose increase in increments of 3.5 to 7 mg/kg if
the patient’s LIC is ≥7 mg Fe/g dw, or serum ferritin
is consistently >2,000 µg/L and not showing a downward trend, and the
patient is tolerating the drug well. Doses above
14 mg/kg are not recommended because there is no experience with doses
above this level in patients with
non-transfusion-dependent thalassemia syndromes.
In patients in whom LIC was not assessed and serum ferritin is
≤2,000 µg/L, dosing should not exceed 7 mg/kg.
For patients in whom the dose was increased to >7 mg/kg, dose
reduction is recommended to 7 mg/kg or less when LIC
is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/L.
Once a satisfactory body iron level has been achieved (LIC <3 mg Fe/g
dw or serum ferritin <300