Drug Action
Deferasirox is an oral iron chelator.
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Drug reference
Deferasirox is an oral iron chelator.
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Transfusion-related chronic iron overload in patients with beta thalassaemia major who receive frequent blood transfusions (7 mL/kg/month or more of packed red blood cells) (specialist use only) ▶BY MOUTH ▶Adult: Initially 7–21 mg/kg once daily, dose adjusted according to serum-ferritin concentration and amount of transfused blood—consult product literature, then adjusted in steps of 3.5–7 mg/kg every 3–6 months, maintenance dose adjusted according to serum-ferritin concentration; maximum 28 mg/kg per day; Usual maximum 21 mg/kg Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with beta thalassaemia major who receive infrequent blood transfusions (less than 7 mL/kg/month of packed red blood cells) (specialist use only) | Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with other anaemias (specialist use only) ▶BY MOUTH ▶Adult: Initially 7–21 mg/kg once daily, dose adjusted according to serum-ferritin concentration and amount of transfused blood—consult product literature, then adjusted in steps of 3.5–7 mg/kg every 3–6 months, maintenance dose adjusted according to serum-ferritin concentration; maximum 28 mg/kg per day; Usual maximum 21 mg/kg Chronic iron overload when desferrioxamine is contra- indicated or inadequate in non-transfusion-dependent thalassaemia syndromes (specialist use only) ▶BY MOUTH ▶Adult: Initially 7 mg/kg once daily, then adjusted in steps of 3.5–7 mg/kg every 3–6 months, maintenance dose adjusted according to serum-ferritin concentration and liver-iron concentration (consult product literature); maximum 14 mg/kg per day
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Elderly (increased risk of side-effects). history of liver cirrhosis. not recommended in conditions which may reduce life expectancy (e.g. high-risk myelodysplastic syndromes). platelet count less than 50x109/litre. risk of gastro-intestinal ulceration and haemorrhage. unexplained cytopenia—consider treatment interruption
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Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (June 2017) that deferasirox (Exjade ®) is accepted for restricted use within NHS Scotland for the treatment of chronic iron overload associated with the treatment of rare acquired or inherited anaemias requiring recurrent blood transfusions. It is not recommended for patients with myelodysplastic syndromes. Patients with myelodysplastic syndromes, the commonest cause of transfusion-dependent anaemia, were poorly represented in the clinical trial population and the economic case was not demonstrated in this group.
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→Appendix 1: iron chelators
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▶Common or very common Constipation. diarrhoea. gastrointestinal discomfort. headache. nausea. skin reactions. urine abnormalities. vomiting ▶Uncommon Anxiety. cataract. cholelithiasis. dizziness. fatigue. fever. gastrointestinal disorders. gastrointestinal haemorrhage (including fatal cases). hearing impairment. hepatic disorders. laryngeal pain. maculopathy. oedema. renal tubular disorders. sleep disorder ▶Rare or very rare Optic neuritis. severe cutaneous adverse reactions (SCARs) ▶Frequency not known Acute kidney injury. alopecia. anaemia aggravated. hyperammonaemic encephalopathy. hypersensitivity vasculitis. lens opacity. leucopenia. metabolic acidosis. nephritis tubulointerstitial. nephrolithiasis. neutropenia. pancreatitis acute. pancytopenia. renal tubular necrosis. thrombocytopenia
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Manufacturer advises avoid unless essential— toxicity in animal studies.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises caution in moderate impairment; avoid in severe impairment. Dose adjustments Manufacturer advises reduce initial dose considerably then gradually increase to max. 50% of normal dose in moderate impairment.
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Manufacturer advises avoid if estimated creatinine clearance less than 60 mL/minute. Dose adjustments Manufacturer advises reduce dose if creatinine clearance less than 90 mL/minute and serum creatinine increased by more than 33% of baseline measurement on 2 consecutive occasions—consult product literature.
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Manufacturer advises monitoring of the following patient parameters: baseline serum creatinine twice and creatinine clearance once before initiation of treatment, weekly in the first month after treatment initiation or modification, then monthly thereafter; proteinuria before treatment initiation then monthly thereafter, and other markers of renal tubular function as needed; liver function before treatment initiation, every 2 weeks during the first month of treatment, then monthly thereafter; eye and ear examinations before treatment and annually during treatment; serum-ferritin concentration monthly.
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For film-coated tablets, manufacturer advises tablets may be crushed and sprinkled on to soft food (yoghurt or apple sauce), then administered immediately.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Exjade (Novartis Pharmaceuticals UK Ltd) A Deferasirox 90 mg Exjade 90mg tablets | 30 tablet P £126.00 DT = £126.00 Deferasirox 180 mg Exjade 180mg tablets | 30 tablet P £252.00 DT = £252.00 Deferasirox 360 mg Exjade 360mg tablets | 30 tablet P £504.00 DT = £504.00
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Patient or carers should be Blood and nutrition given advice on how to administer deferasirox tablets.
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Initially 7–21 mg/kg once daily, dose adjusted
First-line fragment. Read the complete Indications and Dose section above.
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Initially 7–21 mg/kg once daily, dose adjusted
First-line fragment. Read the complete Indications and Dose section above.
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Initially 7 mg/kg once daily, then adjusted in
First-line fragment. Read the complete Indications and Dose section above.
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