Composition:
Dispersible tables containing 125,250 or 500
mg deferasirox. Indication
:
Treatment of transfusion – induced haemosiderosis.
Dosage and Administration :
The recommended initial dose of Exjade is 20 mg/kg once
daily. It is recommended that in patients who receive
regular blood transfusion ( more than 8 units of packed
red blood cells per year) therapy with Exjade be started
after the transfusion of approximately 20 units (equivalent
to 100 ml/kg) of packed red blood cells or when there
is evidence from clinical monitoring that chronic iron
overload is present (serum territin > 100 pg / l
or liver iron concentration of > 2 mg / g dry weight)
An initial dose of 30 mg/kg/day may
be considered in patients receiving more than 14 ml
/ kg/ month of packed red blood cells (i.e more than
4 units per month in adults ) and in whom a reduction
of the existing iron exposure is desired . Doses exceeding
30 mg / kg are not recommended because there is only
limited experience with doses above this level. An dose
of 10 mg / kg / day may be considered in patients receiving
less than 7 ml / kg / month of packed red blood cells
( i.e less than 2 units per month in adults) and in
whom the level of iron should neither increase nor decrease
No experience in children aged below 2 years; use in
this age group therefore not recommended . To be taken
on an empty stomatch at least 30 minutes before food.
Suspension in water or orange juice. Monthly determination
of serum territin, dose titration in increments of 5
– 10 mg/kg/ every 3-6 months. If serum ferritin
is below 500 ug/l at several consecutive determinations,
treatment should be interrupted.
Contraindications:
Hypersensitivity to the above substance or any of the
excipients.
Warnings and
precautions :
Renal or hepatic impairment. Monthly monitoring of serum
creatinine. The daily dose can be reduce in the event
of a non-progressive rise in serum creatinine. If there
is a progressive increase in serum creatinine beyond
the upper limit of normal, Exjade should be discontinued.
Monthly monitoring of liver function. Exjade should
be discontinued if there is a persistent and progressive
increase in serum transaminase levels that can not be
attributed to other causes.Caution in patients with
congenital disturbances of glucuronidation, aluminium
overload, galactose intolerance, servere lactase deficiency
or glucose – galactose malabsorption. And during
pregnancy and lactation. Service skin rash may necessitate
interruption of treatment. Annual auditory and ophthalmic
testing: If disturbances are noted, dose reduction or
withdrawal of the drug may be considered. Must not be
combined with other iron chelator therapies.
Interactions:
Avoid ingestion of aluminium – containing antacid
preparations within 2 hours of Exjade ingestion, suspension
in apple juice not recommended, interrupt Exjade therapy
at least 5 days before gallium – 67 scintigraphy.
Undesirable
effects:
Common: Headache, diarrhoea, constipation, vomiting,
nausea, abdominal pain, abdominal distension dyspepsia,
elevated transaminases, rash proteinuria, increased
serum creatinine Uncommon: Anxiety, sleep disturbances
dizziness, early cataract, maculopathy, hearing loss,
gastritis, pharyngitis, hepatitis, cholelithiasis, pigmentation
disorder, fever oedema, fatigue.
Pack sizes:
Packs containing 28 or 84 dispersible tables of 125
, 250 or 500 mg deferasirox.
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