Asunra^®

Presentation: dispersible tablets containing 100 mg, 400 mg of deferasirox.

Indications: for adults and paediatric patients aged 2 years and over with chronic iron overload due to blood transfusions (transfusional haemosiderosis).

Dosage: ¨Starting daily dose: Recommended initial daily dose is 20 mg/kg body weight; consider 30 mg/kg for patients receiving >14 mL/kg/month of packed red blood cells (>4 units/month), and for whom the objective is reduction of iron overload; consider 10 mg/kg for patients receiving <7 mL/kg/month of packed red blood cells (<2 units/month), and for whom the objective is maintenance of the body iron level; for patients already well-managed on treatment with deferoxamine, consider a starting dose of Asunra^® that is numerically half that of the deferoxamine dose ¨Asunra must be taken once daily on an empty stomach at least 30 minutes before food ¨Asunra tablets to be dispersed in water or apple or orange juice ¨Monthly monitoring of serum ferritin for assessing patient’s response to therapy ¨Maintenance daily dose to be adjusted if necessary every 3 to 6 months based on serum ferritin trends. Dose adjustments should be made in steps of 5 to 10 mg/kg. Asunra should be interrupted if serum ferritin falls consistently below 500 micrograms/L ¨Maximum daily dose is 30 mg/kg body weight.

Contraindications: hypersensitivity to deferasirox or to any of the excipients.

Warnings/Precautions: ¨monthly monitoring of serum creatinine and proteinuria: dose reduction may be needed in some cases of non-progressive increase in serum creatinine; Asunra should be interrupted if serum creatinine shows a progressive rise beyond the age-appropriate upper limit of normal. More frequent creatinine monitoring recommended in patients with an increased risk of renal complications ¨monthly monitoring of serum transaminases: Asunra should be interrupted if persistent and progressive unattributable increase in serum transaminases levels ¨Asunra has not been studied in patients with renal and hepatic impairment and should be used with caution in such patients ¨skin rashes: Asunra should be interrupted if severe rash develops ¨discontinue if severe hypersensitivity reaction occurs ¨annual ophthalmological/audiological testing ¨should not be used during pregnancy unless clearly necessary ¨not recommended when breast-feeding ¨must not be combined with other iron chelator therapies ¨product contains lactose.

Interactions: ¨should not be taken with aluminium-containing antacids.

Adverse reactions: ¨most common adverse reactions: nausea, vomiting, diarrhoea, abdominal pain, rash, non-progressive increase in serum creatinine, increased transaminases, abdominal distension, constipation, dyspepsia, proteinuria, headache ¨less common adverse reactions but potentially serious: acute renal failure, hypersensitivity reactions (including anaphylaxis and angioedema), severe skin rash, maculopathy, hepatitis, leukocytoclastic vasculitis, urticaria. As with other iron chelator therapy, high-frequency hearing loss and early cataracts have been uncommonly observed.

Packs : Pack of 30 Tabs of 100 mg & 400 mg

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