Clinical Pharmacology Details


Deferasirox


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Indications & Dose:

Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with thalassaemia major who receive infrequent blood transfusions (less than 7 mL/kg/month of packed red blood cells) | Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with other anaemias | Treatment of chronic iron overload in patients with thalassaemia major who receive frequent blood transfusions (more than 7 mL/kg/month of packed red blood cells) 



Adult: Initially 10–30 mg/kg once daily, dose adjusted


according to serum-ferritin concentration and amount of transfused blood—consult product literature; adjusted in steps of 5–10 mg/kg every 3–6 months, maintenance dose adjusted according to serum-ferritin concentration; maximum 40 mg/ kg per day; Usual maximum 30 mg/kg


Treatment of chronic iron overload when desferrioxamine is contra-indicated or inadequate (with non transfusiondependent thalassaemia syndromes)



Adult: Initially 10 mg/kg once daily; adjusted in steps of 5–10 mg/kg every 3–6 months, maintenance dose adjusted according to serumferritin concentration and liver-iron concentration (consult product literature); maximum 20 mg/kg per day 

Contraindications:

Side Effects:

gastro-intestinal disturbances; headache proteinuria; pruritus, rash; less commonly hepatitis, cholelithiasis, oedema, fatigue, anxieW sleep disorder dizziness, pyrexia, pharyngitis, glucosuria, disturbances of hearing and vision (including lens opacity and maculopathy), and skin pigmentation; acute rena failure, blood disorders (including agranulocytosis, neutropenia, and thrombocytopenia), hypersensitivit3 reactions (including anaphylaxis and angioedema) also reported 

Cautions:

eye and ear examinations required before treatment and annually during treatment; monitor body-wetght, height, and sexual development in children annually; test liver function monthly; see also hepatic impairment  ; measure baseline serum creatinine and monitor renal function weekly during the first month of treatment and monthly thereafter; test for proteinuria monthly; see also rena impairment ; pregnancy 

Precautions:

Interaction:

DRUGS
aluminum-containing antacids, cholestyramine, phenobarbital, phenytoin, rifampicin, ritonavir: Possibly decreased effectiveness of deferasirox anticoagulants, corticosteroids, NSAIDs, oral bisphosphonates: Increased risk of GI ulceration or hemorrhage


cydobenzaprine, imipramine, haloperidol, fluvoxamine, mexiletine, olanzapine, tizanidine, zileution, zolmitriptan: Possible increased plasma levels and effects of these drugs cyclosporine, hormonal contraceptives,


midazolam, simvastatin: Possibly decreased effectiveness of these drugs


iron chelators: Possibly combined effect paclitaxel, repaglinide, theophylline: Increased

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: