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EXJADE^®

Important note: Before prescribing, consult full prescribing information.

Presentation: Dispersible tablets containing 125 mg, 250 mg or 500 mg of deferasirox.

Indications: For the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older . Also for the treatment of chronic iron overload due to blood transfusion in patients aged 2 years and older with β-thalassaemia major or other anaemias when deferoxamine is contraindicated or inadequate.

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 EXJADE^® that is numerically half that of the deferoxamine dose.
• EXJADE must be taken once daily on an empty stomach at least 30 minutes before food.
• EXJADE 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. In patients not adequately controlled with doses of 30 mg/kg, doses of up to 40 mg/kg may be considered. In patients treated with doses greater than 30 mg/kg, dose reductions in steps of 5 to 10 mg/kg should be considered when control has been achieved (e.g. serum ferritin levels persistently below 2,500 μg/l and showing a decreasing trend over time). In patients whose serum ferritin level has reached the target (usually between 500 and 1000 μg/l) , dose reductions in steps of 5 to 10 mg/kg should be considered to maintain serum ferritin levels within the target range. EXJADE should be interrupted if serum ferritin falls consistently below 500 μg/l.
• Maximum daily dose is 40 mg/kg body weight.

Contraindications:

• Hypersensitivity to deferasirox or to any of the excipients.
• Patients with estimated creatinine clearance <60 ml/min.
• Combination with other iron therapy as the safety of such combinations has not been established.

Warnings/Precautions:

• Caution in elderly patients due to a higher frequency of adverse reactions.
• Not recommended in patients with a short life expectancy (e.g. high-risk myelodysplastic syndromes), especially when co-morbidities could increase the risk of adverse events.
• Renal - During clinical trials, dose-dependent increases in serum creatinine occurred in about 36% of patients. Acute renal failure, sometime requiring temporary or permanent dialysis, and renal tubulopathy, mainly in children and adolescents with beta-thalassemia, have been reported following post-marketing use of Exjade. Particular attention should be taken to monitoring of serum creatinine in patients on concomitant medicinal products that depress renal function, patients with pre-existing renal conditions, and in patients receiving high doses of Exjade and/or low rates of transfusion.. Serum creatinine, creatinine clearance and/or plasma cystatin C levels should be monitored weekly in the first month after initiation or modification of therapy, and monthly thereafter. Tests for proteinuria should be performed monthly.. In adult and pediatric patients daily dose may be reduced by 10 mg/kg if serum creatinine rises above pretreatment or normal levels and/or creatinine clearance decreases below normal range at two consecutive visits, and cannot be attributed to other causes. After a dose reduction, treatment should be interrupted if a further rise in serum creatinine and/or decrease in creatinine clearance is observed.
• Hepatic - Liver function test elevations have been observed. Post-marketing cases of hepatic failure, sometimes fatal, have been reported. Monitoring of serum transaminases, bilirubin and alkaline phosphatase: before the initiation of treatment, every 2 weeks during the first month and monthly thereafter. EXJADE should be interrupted if persistent and progressive increase in serum transaminases levels that cannot be attributed to other causes. Not recommended in patients with severe hepatic impairment.
• Gastrointestinal - Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children and adolescents. Multiple ulcers have been observed in some patients. There have been reports of fatal GI haemorrhages, especially in elderly patients who had advanced haematologic malignancies and/or low platelet counts. Caution in patients with platelet counts <50 x 10⁹/l.
• Skin rashes - EXJADE should be interrupted if severe rash develops.
• Hypersensitivity - Cases of serious hypersensitivity (such as anaphylaxis and angioedema) have been reported. Discontinue if severe hypersensitivity reaction occurs.
• Vision/hearing - Decreased hearing and lens opacities have been reported. Annual ophthalmological/auditory testing.
• Blood disorders - Leukopenia, thrombocytopenia or pancytopenia has been reported, especially in patients with pre-existing haematological disorders. Should not be used during pregnancy unless clearly necessary.
• Not recommended when breastfeeding.
• Cardiac function should be monitored.
• Product contains lactose.

Interactions:

• Should not be taken with aluminium-containing antacids.
• Caution when combined with drugs metabolized through CYP3A4 (e.g. ciclosporin, simvastatin, hormonal contraceptive agents, midazolam).
• Increases in the dose of Exjade should be considered when concomitantly used with potent UGT inducers (e.g. rifampicin, phenytoin, phenobarbital, ritonavir).
• Careful monitoring of glucose levels should be performed when repaglinide is used concomitantly with EXJADE. Interaction with other CYP2C8 substrates like paclitaxel cannot be excluded.
• Consider monitoring of theophylline concentration and possible theophylline dose reduction. Interaction with other CYP1A2 substrates may be possible.
• Caution when combined with drugs with ulcerogenic potential (e.g. NSAIDS, corticosteroids, oral bisphosphonates) or with anticoagulants.

Adverse reactions:

• The most frequent reactions reported during chronic treatment with EXJADE in adult and paediatric patients include gastrointestinal disturbances (mainly nausea, vomiting, diarrhoea or abdominal pain) and skin rash. Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years and in the elderly. Increases in serum creatinine were also observed. These reactions are dose-dependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued.

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