Paediatric population

The dosing recommendations for paediatric patients aged 2 to 17 years are the same as for adult patients. Changes in weight of paediatric patients over time must be taken into account when calculating the dose.

In children aged between 2 and 5 years, exposure is lower than in adults (see section 5.2). This age group may therefore require higher doses than are necessary in adults. However, the initial dose should be the same as in adults, followed by individual titration.

The safety and efficacy of EXJADE in children from birth to 23 months of age have not yet been established. No data are available.

Patients with renal impairment

EXJADE has not been studied in patients with renal impairment and is contraindicated in patients with estimated creatinine clearance <60 ml/min (see sections 4.3 and 4.4).

Patients with hepatic impairment

EXJADE has not been studied in patients with hepatic impairment and must be used with caution in such patients. The initial dosing recommendations for patients with hepatic impairment are the same as described above. Hepatic function in all patients should be monitored before treatment, every 2 weeks during the first month and then every month (see section 4.4).

Method of administration

For oral use.

EXJADE must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.5 and 5.2).

The tablets are dispersed by stirring in a glass of water or orange or apple juice (100 to 200 ml) until a fine suspension is obtained. After the suspension has been swallowed, any residue must be resuspended in a small volume of water or juice and swallowed. The tablets must not be chewed or swallowed whole (see also section 6.2).

4.3 Contraindications

 Hypersensitivity to the active substance or to any of the excipients.

Combination with other iron chelator therapies as the safety of such combinations has not been established (see section 4.5).

Patients with estimated creatinine clearance <60 ml/min.

4.4 Special warnings and precautions for use

 Renal function:

EXJADE has been studied only in patients with baseline serum creatinine within the age-appropriate normal range.

During clinical trials, increases in serum creatinine of >33% on 2 consecutive occasions, sometimes above the upper limit of the normal range, occurred in about 36% of patients. These were dose-dependent. About two-thirds of the patients showing serum creatinine increase returned below the 33% level without dose adjustment. In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption. Cases of acute renal failure have been reported following post-marketing use of EXJADE (see section 4.8). In some post-marketing cases, renal function deterioration has led to renal failure requiring temporary or permanent dialysis.

The causes of the rises in serum creatinine have not been elucidated. Particular attention should therefore be paid to monitoring of serum creatinine in patients who are concomitantly receiving medicinal products that depress renal function, and in patients who are receiving high doses of EXJADE and/or low rates of transfusion (<7 ml/kg/month of packed red blood cells or &