Exjade

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 



 

2 

This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

1. NAME OF THE MEDICINAL PRODUCT 
 

EXJADE 125 mg dispersible tablets 

EXJADE 250 mg dispersible tablets 

EXJADE 500 mg dispersible tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

EXJADE 125 mg dispersible tablets 

Each dispersible tablet contains 125 mg deferasirox. 

 

Excipient with known effect: 

Each dispersible tablet contains 136 mg lactose. 

 

EXJADE 250 mg dispersible tablets 

Each dispersible tablet contains 250 mg deferasirox. 

 

Excipient with known effect: 

Each dispersible tablet contains 272 mg lactose. 

 

EXJADE 500 mg dispersible tablets 

Each dispersible tablet contains 500 mg deferasirox. 

 

Excipient with known effect: 

Each dispersible tablet contains 544 mg lactose. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Dispersible tablet 

 

EXJADE 125 mg dispersible tablets 

White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and 

J 125 on the other). Approximate tablet dimensions 12 mm x 3.6 mm. 

 

EXJADE 250 mg dispersible tablets 

White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and 

J 250 on the other). Approximate tablet dimensions 15 mm x 4.7 mm. 

 

EXJADE 500 mg dispersible tablets 

White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and 

J 500 on the other). Approximate tablet dimensions 20 mm x 5.6 mm. 

 

 



 

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4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

EXJADE is indicated 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. 
 

EXJADE is also indicated for the treatment of chronic iron overload due to blood transfusions when 

deferoxamine therapy is contraindicated or inadequate in the following patient groups: 

- in paediatric patients with beta thalassaemia major with iron overload due to frequent blood 

transfusions (7 ml/kg/month of packed red blood cells) aged 2 to 5 years, 

- in adult and paediatric patients with beta thalassaemia major with iron overload due to 

infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and 

older, 

- in adult and paediatric patients with other anaemias aged 2 years and older. 
 

EXJADE is also indicated for the treatment of chronic iron overload requiring chelation therapy when 

deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent 

thalassaemia syndromes aged 10 years and older. 

 

4.2 Posology and method of administration 
 

Treatment with EXJADE should be initiated and maintained by physicians experienced in the 

treatment of chronic iron overload. 

 

Posology 

 

Transfusional iron overload 

 

It is recommended that treatment be started after the transfusion of approximately 20 units (about 

100 ml/kg) of packed red blood cells (PRBC) or when there is evidence from clinical monitoring that 

chronic iron overload is present (e.g. serum ferritin >1,000 µg/l). Doses (in mg/kg) must be calculated 

and rounded to the nearest whole tablet size. 

 

The goals of iron chelation therapy are to remove the amount of iron administered in transfusions and, 

as required, to reduce the existing iron burden. 

 

Caution should be taken during chelation therapy to minimise the risk of overchelation in all patients 

(see section 4.4). 

 

In case of switching from film-coated tablets/granules to dispersible tablets, the dose of dispersible 

tablets should be 40% higher than the dose of film-coated tablets/granules, rounded to the nearest 

whole tablet. 

 

The corresponding doses for the different formulations are shown in the table below. 

 



 

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Table 1 Recommended doses for transfusional iron overload 

 

 Film-coated 

tablets/granules 

Dispersible tablets Transfusions  Serum 

ferritin 

Starting dose 14 mg/kg/day 20 mg/kg/day After 20 units 

(about 100 ml/kg) 

of PRBC 

or >1,000 µg/l 

Alternative 

starting doses 

21 mg/kg/day 30 mg/kg/day >14 ml/kg/month 

of PRBC (approx. 

>4 units/month 

for an adult) 

  

 7 mg/kg/day 10 mg/kg/day <7 ml/kg/month 

of PRBC (approx. 

<2 units/month 

for an adult) 

  

For patients 

well managed 

on 

deferoxamine 

One third of 

deferoxamine dose 

Half of 

deferoxamine dose 

   

Monitoring     Monthly 

Target range     500-1,000 µg/l 

      

Adjustment 

steps 
(every 

3-6 months) 

Increase   >2,500 µg/l 

3.5 - 7 mg/kg/day 

Up to 28 mg/kg/day 

5-10 mg/kg/day 

Up to 40 mg/kg/day 

   

Decrease    

3.5 - 7 mg/kg/day 5-10 mg/kg/day   <2,500 µg/l 

In patients treated 

with doses 

>21 mg/kg/day 

In patients treated 

with doses 

>30 mg/kg/day 

   

- When target is reached   500-1,000 µg/l 

Maximum 

dose 

28 mg/kg/day 40 mg/kg/day    

Consider 

interruption 

    <500 µg/l 

 

Starting dose 

The recommended initial daily dose of EXJADE dispersible tablets is 20 mg/kg body weight. 

 

An initial daily dose of 30 mg/kg may be considered for patients who require reduction of elevated 

body iron levels and who are also receiving more than 14 ml/kg/month of packed red blood cells 

(approximately >4 units/month for an adult). 

 

An initial daily dose of 10 mg/kg may be considered for patients who do not require reduction of body 

iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells 

(approximately <2 units/month for an adult). The patient’s response must be monitored and a dose 

increase should be considered if sufficient efficacy is not obtained (see section 5.1). 

 

For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE 

dispersible tablets that is numerically half that of the deferoxamine dose could be considered (e.g. a 

patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be 

transferred to a starting daily dose of 20 mg/kg/day of EXJADE dispersible tablets). When this results 

in a daily dose less than 20 mg/kg body weight, the patient’s response must be monitored and a dose 

increase should be considered if sufficient efficacy is not obtained (see section 5.1). 

 



 

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Dose adjustment 

It is recommended that serum ferritin be monitored every month and that the dose of EXJADE be 

adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin. Dose adjustments 

may be made in steps of 5 to 10 mg/kg and are to be tailored to the individual patient’s response and 

therapeutic goals (maintenance or reduction of iron burden). In patients not adequately controlled with 

doses of 30 mg/kg (e.g. serum ferritin levels persistently above 2,500 µg/l and not showing a 

decreasing trend over time), doses of up to 40 mg/kg may be considered. The availability of long-term 

efficacy and safety data with EXJADE dispersible tablets used at doses above 30 mg/kg is currently 

limited (264 patients followed for an average of 1 year after dose escalation). If only very poor 

haemosiderosis control is achieved at doses up to 30 mg/kg, a further increase (to a maximum of 

40 mg/kg) may not achieve satisfactory control, and alternative treatment options may be considered. 

If no satisfactory control is achieved at doses above 30 mg/kg, treatment at such doses should not be 

maintained and alternative treatment options should be considered whenever possible. Doses above 

40 mg/kg are not recommended because there is only limited experience with doses above this level. 

 

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 1,000 µg/l), dose reductions in steps of 5 to 10 mg/kg should be 

considered to maintain serum ferritin levels within the target range and to minimise the risk of 

overchelation. If serum ferritin falls consistently below 500 µg/l, an interruption of treatment should 

be considered (see section 4.4). 

 

Non-transfusion-dependent thalassaemia syndromes 

 

Chelation therapy should only be initiated when there is evidence of iron overload (liver iron 

concentration [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin consistently >800 µg/l). LIC is the 

preferred method of iron overload determination and should be used wherever available. Caution 

should be taken during chelation therapy to minimise the risk of overchelation in all patients (see 

section 4.4). 

 

In case of switching from film-coated tablets/granules to dispersible tablets, the dose of dispersible 

tablets should be 40% higher than the dose of film-coated tablets/granules, rounded to the nearest 

whole tablet. 

 

The corresponding doses for the different formulations are shown in the table below. 

 

Table 2 Recommended doses for non-transfusion-dependent thalassaemia syndromes 

 

 Film-coated 

tablets/granules 

Dispersible 

tablets 

Liver iron 

concentration 

(LIC)* 

 Serum 

ferritin 

Starting dose 7 mg/kg/day 10 mg/kg/day ≥5 mg Fe/g dw or >800 µg/l 

Monitoring     Monthly 

Adjustment 

steps 
(every 

3-6 months) 

Increase ≥7 mg Fe/g dw or >2,000 µg/l 

3.5 - 7 mg/kg/day 5-10 mg/kg/day    

Decrease <7 mg Fe/g dw or ≤2,000 µg/l 

3.5 - 7 mg/kg/day 5-10 mg/kg/day    

Maximum 

dose 

14 mg/kg/day 20 mg/kg/day    

 7 mg/kg/day 10 mg/kg/day    

 For adults not assessed and ≤2,000 µg/l 
 For paediatric patients    

Interruption   <3 mg Fe/g dw or <300 µg/l 

Retreatment   Not recommended 

*LIC is the preferred method of iron overload determination. 



 

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Starting dose 

The recommended initial daily dose of EXJADE dispersible tablets in patients with 

non-transfusion-dependent thalassaemia syndromes is 10 mg/kg body weight. 

 

Dose adjustment 

It is recommended that serum ferritin be monitored every month to assess the patient’s response to 

therapy and to minimise the risk of overchelation (see section 4.4). After every 3 to 6 months of 

treatment, a dose increase in increments of 5 to 10 mg/kg should be considered if the patient’s LIC is 

≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and 

the patient is tolerating the medicinal product well. Doses above 20 mg/kg are not recommended 

because there is no experience with doses above this level in patients with non-transfusion-dependent 

thalassaemia syndromes. 

 

In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 

10 mg/kg. 

 

For patients in whom the dose was increased to >10 mg/kg, dose reduction to 10 mg/kg or less is 

recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l. 

 

Treatment cessation 

Once a satisfactory body iron level has been achieved (LIC <3 mg Fe/g dw or serum ferritin 

<300 µg/l), treatment should be stopped. There are no data available on the retreatment of patients 

who reaccumulate iron after having achieved a satisfactory body iron level and therefore retreatment 

cannot be recommended. 

 

Special populations 

 

Elderly patients (≥65 years of age) 

The dosing recommendations for elderly patients are the same as described above. In clinical studies, 

elderly patients experienced a higher frequency of adverse reactions than younger patients (in 

particular, diarrhoea) and should be monitored closely for adverse reactions that may require a dose 

adjustment. 

 

Paediatric population 

Transfusional iron overload: 

The dosing recommendations for paediatric patients aged 2 to 17 years with transfusional iron 

overload are the same as for adult patients (see section 4.2). It is recommended that serum ferritin be 

monitored every month to assess the patient’s response to therapy and to minimise the risk of 

overchelation (see section 4.4). Changes in weight of paediatric patients over time must be taken into 

account when calculating the dose. 

 

In children with transfusional iron overload 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. 

 

Non-transfusion-dependent thalassaemia syndromes: 

In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not 

exceed 10 mg/kg. In these patients, closer monitoring of LIC and serum ferritin is essential to avoid 

overchelation (see section 4.4). In addition to monthly serum ferritin assessments, LIC should be 

monitored every three months when serum ferritin is ≤800 µg/l. 

 

Children from birth to 23 months: 

The safety and efficacy of EXJADE in children from birth to 23 months of age have not been 

established. No data are available. 

 



 

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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 is not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In 

patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be considerably 

reduced followed by progressive increase up to a limit of 50% (see sections 4.4 and 5.2), and EXJADE 

must be used with caution in such patients. 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 dispersible tablets 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 dispersible 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 listed in section 6.1. 

 

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 

 

Deferasirox has been studied only in patients with baseline serum creatinine within the 

age-appropriate normal range. 

 

During clinical studies, 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. In some cases, only a stabilisation of the 

serum creatinine values has been observed after dose reduction. Cases of acute renal failure have been 

reported following post-marketing use of deferasirox (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 

deferasirox and/or low rates of transfusion (<7 ml/kg/month of packed red blood cells or 

<2 units/month for an adult). While no increase in renal adverse events was observed after dose 

escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk 

of renal adverse events with EXJADE dispersible tablet doses above 30 mg/kg cannot be excluded. 

 



 

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It is recommended that serum creatinine be assessed in duplicate before initiating therapy. Serum 

creatinine, creatinine clearance (estimated with the Cockcroft-Gault or MDRD formula in adults and 

with the Schwartz formula in children) and/or plasma cystatin C levels should be monitored prior to 

therapy, weekly in the first month after initiation or modification of therapy with EXJADE 

(including switch of formulation), and monthly thereafter. Patients with pre-existing renal 

conditions and patients who are receiving medicinal products that depress renal function may be more 

at risk of complications. Care should be taken to maintain adequate hydration in patients who develop 

diarrhoea or vomiting. 

 

There have been post-marketing reports of metabolic acidosis occurring during treatment with 

deferasirox. The majority of these patients had renal impairment, renal tubulopathy (Fanconi 

syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication. Acid-base 

balance should be monitored as clinically indicated in these populations. Interruption of EXJADE 

therapy should be considered in patients who develop metabolic acidosis. 

 

Post-marketing cases of severe forms of renal tubulopathy (such as Fanconi syndrome) and renal 

failure associated with changes in consciousness in the context of hyperammonaemic encephalopathy 

have been reported in patients treated with deferasirox, mainly in children. It is recommended that 

hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who 

develop unexplained changes in mental status while on Exjade therapy. 

 

Table 3 Dose adjustment and interruption of treatment for renal monitoring 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Treatment may be reinitiated depending on the individual clinical circumstances. 

 

 Serum creatinine  Creatinine clearance 

Before initiation of 

therapy 

Twice (2x) and Once (1x) 

Contraindicated   <60 ml/min 

Monitoring    

- First month after 

start of therapy or 

dose modification 

(including switch 

of formulation) 

Weekly and Weekly 

- Thereafter Monthly and Monthly 

Reduction of daily dose by 10 mg/kg/day (dispersible tablet formulation), 

if following renal parameters are observed at two consecutive visits and cannot be attributed to 

other causes 

Adult patients >33% above pre-

treatment average 

and Decreases <LLN* 

(<90 ml/min) 

Paediatric patients > age appropriate 

ULN**  

and/or Decreases <LLN* 

(<90 ml/min) 

After dose reduction, interrupt treatment, if 

Adult and paediatric Remains >33% above 

pre-treatment average 

and/or Decreases <LLN* 

(<90 ml/min) 

*LLN: lower limit of the normal range 

**ULN: upper limit of the normal range 

 



 

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Dose reduction or interruption may be also considered if abnormalities occur in levels of markers of 

renal tubular function and/or as clinically indicated: 

• Proteinuria (test should be performed prior to therapy and monthly thereafter) 

• Glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, 

phosphaturia, aminoaciduria (monitor as needed). 

Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated 

with EXJADE. 

 

Patients should be referred to a renal specialist, and further specialised investigations (such as renal 

biopsy) may be considered if the following occur despite dose reduction and interruption: 

• Serum creatinine remains significantly elevated and 

• Persistent abnormality in another marker of renal function (e.g. proteinuria, Fanconi Syndrome). 

 

Hepatic function 

 

Liver function test elevations have been observed in patients treated with deferasirox. Post-marketing 

cases of hepatic failure, some of which were fatal, have been reported. Severe forms associated with 

changes in consciousness in the context of hyperammonaemic encephalopathy, may occur in patients 

treated with deferasirox, particularly in children. It is recommended that hyperammonaemic 

encephalopathy be considered and ammonia levels measured in patients who develop unexplained 

changes in mental status while on Exjade therapy. Care should be taken to maintain adequate 

hydration in patients who experience volume-depleting events (such as diarrhoea or vomiting), 

particularly in children with acute illness. Most reports of hepatic failure involved patients with 

significant comorbidities including pre-existing chronic liver conditions (including cirrhosis and 
hepatitis C) and multi-organ failure. The role of deferasirox as a contributing or aggravating factor 

cannot be excluded (see section 4.8). 

 

It is recommended that serum transaminases, bilirubin and alkaline phosphatase be checked before the 

initiation of treatment, every 2 weeks during the first month and monthly thereafter. If there is a 

persistent and progressive increase in serum transaminase levels that cannot be attributed to other 

causes, EXJADE should be interrupted. Once the cause of the liver function test abnormalities has 

been clarified or after return to normal levels, cautious re-initiation of treatment at a lower dose 

followed by gradual dose escalation may be considered. 

 

EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see 

section 5.2). 

 

  



 

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Table 4 Summary of safety monitoring recommendations 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

In patients with a short life expectancy (e.g. high-risk myelodysplastic syndromes), especially when 

co-morbidities could increase the risk of adverse events, the benefit of EXJADE might be limited and 

may be inferior to risks. As a consequence, treatment with EXJADE is not recommended in these 

patients. 

 

Caution should be used in elderly patients due to a higher frequency of adverse reactions (in particular, 

diarrhoea). 

 

Data in children with non-transfusion-dependent thalassaemia are very limited (see section 5.1). As a 

consequence, EXJADE therapy should be closely monitored to detect adverse reactions and to follow 

iron burden in the paediatric population. In addition, before treating heavily iron-overloaded children 

with non-transfusion-dependent thalassaemia with EXJADE, the physician should be aware that the 

consequences of long-term exposure in such patients are currently not known. 

 

Gastrointestinal disorders 

Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children 

and adolescents, receiving deferasirox. Multiple ulcers have been observed in some patients (see 

section 4.8). There have been reports of ulcers complicated with digestive perforation. Also, there 

have been reports of fatal gastrointestinal haemorrhages, especially in elderly patients who had 

haematological malignancies and/or low platelet counts. Physicians and patients should remain alert 

for signs and symptoms of gastrointestinal ulceration and haemorrhage during EXJADE therapy. In 

case of gastrointestinal ulceration or haemorrhage, EXJADE should be discontinued and additional 

evaluation and treatment must be promptly initiated. Caution should be exercised in patients who are 

taking EXJADE in combination with substances that have known ulcerogenic potential, such as 

NSAIDs, corticosteroids, or oral bisphosphonates, in patients receiving anticoagulants and in patients 

with platelet counts below 50,000/mm3 (50 x 109/l) (see section 4.5). 

Test Frequency 

Serum creatinine In duplicate prior to therapy. 

Weekly during first month of therapy or 

after dose modification (including switch 

of formulation). 

Monthly thereafter. 

Creatinine clearance and/or plasma 

cystatin C 

Prior to therapy. 

Weekly during first month of therapy or 

after dose modification (including switch 

of formulation). 

Monthly thereafter. 

Proteinuria Prior to therapy. 

Monthly thereafter. 

Other markers of renal tubular function 

(such as glycosuria in non-diabetics and 

low levels of serum potassium, 

phosphate, magnesium or urate, 

phosphaturia, aminoaciduria) 

As needed. 

Serum transaminases, bilirubin, alkaline 

phosphatase 

Prior to therapy. 

Every 2 weeks during first month of 

therapy. 

Monthly thereafter. 

Auditory and ophthalmic testing Prior to therapy. 

Annually thereafter. 

Body weight, height and sexual 

development 

Prior to therapy. 

Annually in paediatric patients. 

 



 

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Skin disorders 

Skin rashes may appear during EXJADE treatment. The rashes resolve spontaneously in most cases. 

When interruption of treatment may be necessary, treatment may be reintroduced after resolution of 

the rash, at a lower dose followed by gradual dose escalation. In severe cases this reintroduction could 

be conducted in combination with a short period of oral steroid administration. Severe cutaneous 

adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis 

(TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be 

life-threatening or fatal, have been reported. If any SCAR is suspected, EXJADE should be 

discontinued immediately and should not be reintroduced. At the time of prescription, patients should 

be advised of the signs and symptoms of severe skin reactions, and be closely monitored. 

 

Hypersensitivity reactions 

Cases of serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported 

in patients receiving deferasirox, with the onset of the reaction occurring in the majority of cases 

within the first month of treatment (see section 4.8). If such reactions occur, EXJADE should be 

discontinued and appropriate medical intervention instituted. Deferasirox should not be reintroduced 

in patients who have experienced a hypersensitivity reaction due to the risk of anaphylactic shock (see 

section 4.3). 

 

Vision and hearing 

Auditory (decreased hearing) and ocular (lens opacities) disturbances have been reported (see section 

4.8). Auditory and ophthalmic testing (including fundoscopy) is recommended before the start of 

treatment and at regular intervals thereafter (every 12 months). If disturbances are noted during the 

treatment, dose reduction or interruption may be considered. 

 

Blood disorders 

There have been post-marketing reports of leukopenia, thrombocytopenia or pancytopenia (or 

aggravation of these cytopenias) and of aggravated anaemia in patients treated with deferasirox. Most 

of these patients had pre-existing haematological disorders that are frequently associated with bone 

marrow failure. However, a contributory or aggravating role cannot be excluded. Interruption of 

treatment should be considered in patients who develop unexplained cytopenia. 

 

Other considerations 

Monthly monitoring of serum ferritin is recommended in order to assess the patient’s response to 

therapy and to avoid overchelation (see section 4.2). Dose reduction or closer monitoring of renal and 

hepatic function, and serum ferritin levels are recommended during periods of treatment with high 

doses and when serum ferritin levels are close to the target range. If serum ferritin falls consistently 

below 500 µg/l (in transfusional iron overload) or below 300 µg/l (in non-transfusion-dependent 

thalassaemia syndromes), an interruption of treatment should be considered. 

 

The results of the tests for serum creatinine, serum ferritin and serum transaminases should be 

recorded and regularly assessed for trends. 

 

In two clinical studies, growth and sexual development of paediatric patients treated with deferasirox 

for up to 5 years were not affected (see section 4.8). However, as a general precautionary measure in 

the management of paediatric patients with transfusional iron overload, body weight, height and 

sexual development should be monitored prior to therapy and at regular intervals (every 12 months). 

 

Cardiac dysfunction is a known complication of severe iron overload. Cardiac function should be 

monitored in patients with severe iron overload during long-term treatment with EXJADE. 

 

Lactose content 

The dispersible tablets contain lactose. 

 

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or 

glucose-galactose malabsorption should not take this medicinal product. 



 

12 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

The safety of deferasirox in combination with other iron chelators has not been established. Therefore, 

it must not be combined with other iron chelator therapies (see section 4.3). 

 

Interaction with food 

The bioavailability of deferasirox was increased to a variable extent when taken along with food. 

EXJADE dispersible tablets must therefore be taken on an empty stomach at least 30 minutes before 

food, preferably at the same time each day (see sections 4.2 and 5.2). 

 

Agents that may decrease EXJADE systemic exposure 

Deferasirox metabolism depends on UGT enzymes. In a healthy volunteer study, the concomitant 

administration of deferasirox (single dose of 30 mg/kg, dispersible tablet formulation) and the potent 

UGT inducer, rifampicin, (repeated dose of 600 mg/day) resulted in a decrease of deferasirox exposure 

by 44% (90% CI: 37% - 51%). Therefore, the concomitant use of EXJADE with potent UGT inducers 

(e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may result in a decrease in 

EXJADE efficacy. The patient’s serum ferritin should be monitored during and after the combination, 

and the dose of EXJADE adjusted if necessary. 

 

Cholestyramine significantly reduced the deferasirox exposure in a mechanistic study to determine the 

degree of enterohepatic recycling (see section 5.2). 

 

Interaction with midazolam and other agents metabolised by CYP3A4 

In a healthy volunteer study, the concomitant administration of deferasirox dispersible tablets and 

midazolam (a CYP3A4 probe substrate) resulted in a decrease of midazolam exposure by 17% (90% 

CI: 8% - 26%). In the clinical setting, this effect may be more pronounced. Therefore, due to a 

possible decrease in efficacy, caution should be exercised when deferasirox is combined with 

substances metabolised through CYP3A4 (e.g. ciclosporin, simvastatin, hormonal contraceptive 

agents, bepridil, ergotamine). 

 

Interaction with repaglinide and other agents metabolised by CYP2C8 

In a healthy volunteer study, the concomitant administration of deferasirox as a moderate CYP2C8 

inhibitor (30 mg/kg daily, dispersible tablet formulation), with repaglinide, a CYP2C8 substrate, given 

as a single dose of 0.5 mg, increased repaglinide AUC and Cmax about 2.3-fold (90% CI [2.03-2.63]) 

and 1.6-fold (90% CI [1.42-1.84]), respectively. Since the interaction has not been established with 

dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should 

be avoided. If the combination appears necessary, careful clinical and blood glucose monitoring 

should be performed (see section 4.4). An interaction between deferasirox and other CYP2C8 

substrates like paclitaxel cannot be excluded. 

 

Interaction with theophylline and other agents metabolised by CYP1A2 

In a healthy volunteer study, the concomitant administration of deferasirox as a CYP1A2 inhibitor 

(repeated dose of 30 mg/kg/day, dispersible tablet formulation) and the CYP1A2 substrate 

theophylline (single dose of 120 mg) resulted in an increase of theophylline AUC by 84% (90% CI: 

73% to 95%). The single dose Cmax was not affected, but an increase of theophylline Cmax is expected 

to occur with chronic dosing. Therefore, the concomitant use of deferasirox with theophylline is not 

recommended. If deferasirox and theophylline are used concomitantly, monitoring of theophylline 

concentration and theophylline dose reduction should be considered. An interaction between 

deferasirox and other CYP1A2 substrates cannot be excluded. For substances that are predominantly 

metabolised by CYP1A2 and that have a narrow therapeutic index (e.g. clozapine, tizanidine), the 

same recommendations apply as for theophylline. 

 

  



 

13 

Other information 

The concomitant administration of deferasirox and aluminium-containing antacid preparations has not 

been formally studied. Although deferasirox has a lower affinity for aluminium than for iron, it is not 

recommended to take deferasirox tablets with aluminium-containing antacid preparations. 

 

The concomitant administration of deferasirox with substances that have known ulcerogenic potential, 

such as NSAIDs (including acetylsalicylic acid at high dosage), corticosteroids or oral 

bisphosphonates may increase the risk of gastrointestinal toxicity (see section 4.4). The concomitant 

administration of deferasirox with anticoagulants may also increase the risk of gastrointestinal 

haemorrhage. Close clinical monitoring is required when deferasirox is combined with these 

substances. 

 

Concomitant administration of deferasirox and busulfan resulted in an increase of busulfan exposure 

(AUC), but the mechanism of the interaction remains unclear. If possible, evaluation of the 

pharmacokinetics (AUC, clearance) of a busulfan test dose should be performed to allow dose 

adjustment. 

 

4.6 Fertility, pregnancy and lactation 
 

Pregnancy 

No clinical data on exposed pregnancies are available for deferasirox. Studies in animals have shown 

some reproductive toxicity at maternally toxic doses (see section 5.3). The potential risk for humans is 

unknown. 

 

As a precaution, it is recommended that EXJADE is not used during pregnancy unless clearly 

necessary. 

 

EXJADE may decrease the efficacy of hormonal contraceptives (see section 4.5). Women of 

childbearing potential are recommended to use additional or alternative non-hormonal methods of 

contraception when using EXJADE. 

 

Breast-feeding 

In animal studies, deferasirox was found to be rapidly and extensively secreted into maternal milk. No 

effect on the offspring was noted. It is not known if deferasirox is secreted into human milk. 

Breast-feeding while taking EXJADE is not recommended. 

 

Fertility 

No fertility data is available for humans. In animals, no adverse effects on male or female fertility 

were found (see section 5.3). 

 

4.7 Effects on ability to drive and use machines 
 

EXJADE has minor influence on the ability to drive and use machines. Patients experiencing the 

uncommon adverse reaction of dizziness should exercise caution when driving or operating machines 

(see section 4.8). 

 

  



 

14 

4.8 Undesirable effects 

 

Summary of the safety profile 

The most frequent reactions reported during chronic treatment with deferasirox dispersible tablets 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. These reactions are dose-dependent, mostly mild to moderate, generally 

transient and mostly resolve even if treatment is continued. 

 

During clinical studies, dose-dependent increases in serum creatinine occurred in about 36% of 

patients, though most remained within the normal range. Decreases in mean creatinine clearance have 

been observed in both paediatric and adult patients with beta-thalassemia and iron overload during the 

first year of treatment, but there is evidence that this does not decrease further in subsequent years of 

treatment. Elevations of liver transaminases have been reported. Safety monitoring schedules for renal 

and liver parameters are recommended. Auditory (decreased hearing) and ocular (lens opacities) 

disturbances are uncommon, and yearly examinations are also recommended (see section 4.4). 

 

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic 

epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) 

have been reported with the use of EXJADE (see section 4.4). 
 

Tabulated list of adverse reactions 

Adverse reactions are ranked below using the following convention: very common (≥1/10); common 

(≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 

(<1/10,000); not known (cannot be estimated from the available data). Within each frequency 

grouping, adverse reactions are presented in order of decreasing seriousness. 
 

  



 

15 

Table 5 

 

Blood and lymphatic system disorders 

 Not known: Pancytopenia1, thrombocytopenia1, anaemia aggravated1, 
neutropenia1 

Immune system disorders 

 Not known: Hypersensitivity reactions (including anaphylactic reactions and 

angioedema)1 

Metabolism and nutrition disorders 

 Not known: Metabolic acidosis1 

Psychiatric disorders 

 Uncommon: Anxiety, sleep disorder 

Nervous system disorders 

 Common: Headache 

 Uncommon: Dizziness 

Eye disorders 

 Uncommon: Cataract, maculopathy 

 Rare: Optic neuritis 

Ear and labyrinth disorders 

 Uncommon: Deafness 

Respiratory, thoracic and mediastinal disorders 

 Uncommon: Laryngeal pain 

Gastrointestinal disorders 

 Common: Diarrhoea, constipation, vomiting, nausea, abdominal pain, 

abdominal distension, dyspepsia 

 Uncommon: Gastrointestinal haemorrhage, gastric ulcer (including multiple 

ulcers), duodenal ulcer, gastritis 

 Rare: Oesophagitis 

 Not known: Gastrointestinal perforation1, acute pancreatitis1 

Hepatobiliary disorders 

 Common: Transaminases increased 

 Uncommon: Hepatitis, cholelithiasis 

 Not known: Hepatic failure1, 2 

Skin and subcutaneous tissue disorders 

 Common: Rash, pruritus 

 Uncommon: Pigmentation disorder 

 Rare: Drug reaction with eosinophilia and systemic symptoms (DRESS) 

 Not known: Stevens-Johnson syndrome1, hypersensitivity vasculitis1, urticaria1, 

erythema multiforme1, alopecia1, toxic epidermal necrolysis (TEN)1 

Renal and urinary disorders 

 Very common: Blood creatinine increased 

 Common: Proteinuria 

 Uncommon: Renal tubular disorder2 (acquired Fanconi syndrome), glycosuria 

 Not known: Acute renal failure1, 2, tubulointerstitial nephritis1, nephrolithiasis1, 

renal tubular necrosis1 

General disorders and administration site conditions 

 Uncommon: Pyrexia, oedema, fatigue 
1 Adverse reactions reported during post-marketing experience. These are derived from 

spontaneous reports for which it is not always possible to reliably establish frequency or a 

causal relationship to exposure to the medicinal product. 
2 Severe forms associated with changes in consciousness in the context of hyperammonaemic 

encephalopathy have been reported. 

 



 

16 

Description of selected adverse reactions 

Gallstones and related biliary disorders were reported in about 2% of patients. Elevations of liver 

transaminases were reported as an adverse reaction in 2% of patients. Elevations of transaminases 

greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon 

(0.3%). During post-marketing experience, hepatic failure, sometimes fatal, has been reported with 

deferasirox (see section 4.4). There have been post-marketing reports of metabolic acidosis. The 

majority of these patients had renal impairment, renal tubulopathy (Fanconi syndrome) or diarrhoea, 

or conditions where acid-base imbalance is a known complication (see section 4.4). Cases of serious 

acute pancreatitis were observed without documented underlying biliary conditions. As with other iron 

chelator treatment, high-frequency hearing loss and lenticular opacities (early cataracts) have been 

uncommonly observed in patients treated with deferasirox (see section 4.4). 

 

Creatinine clearance in transfusional iron overload 

In a retrospective meta-analysis of 2,102 adult and paediatric beta-thalassaemia patients with 

transfusional iron overload treated with deferasirox dispersible tablets in two randomised and four 

open label studies of up to five years’ duration, a mean creatinine clearance decrease of 13.2% in adult 

patients (95% CI: -14.4% to -12.1%; n=935) and 9.9% (95% CI: -11.1% to -8.6%; n=1,142) in 

paediatric patients was observed during the first year of treatment. In 250 patients who were followed 

for up to five years, no further decrease in mean creatinine clearance levels was observed. 

 

Clinical study in patients with non-transfusion-dependent thalassaemia syndromes 

In a 1-year study in patients with non-transfusion-dependent thalassaemia syndromes and iron 

overload (dispersible tablets at a dose of 10 mg/kg/day), diarrhoea (9.1%), rash (9.1%), and nausea 

(7.3%) were the most frequent study drug-related adverse events. Abnormal serum creatinine and 

creatinine clearance values were reported in 5.5% and 1.8% of patients, respectively. Elevations of 

liver transaminases greater than 2 times the baseline and 5 times the upper limit of normal were 

reported in 1.8% of patients. 

 

Paediatric population 

In two clinical studies, growth and sexual development of paediatric patients treated with deferasirox 

for up to 5 years were not affected (see section 4.4). 

 

Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years than in older patients. 

 

Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated 

with deferasirox. In post-marketing reports, a high proportion of cases of metabolic acidosis occurred 
in children in the context of Fanconi syndrome. 

 

Acute pancreatitis has been reported, particularly in children and adolescents. 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 
 

Early signs of acute overdose are digestive effects such as abdominal pain, diarrhoea, nausea and 

vomiting. Hepatic and renal disorders have been reported, including cases of liver enzyme and 

creatinine increased with recovery after treatment discontinuation. An erroneously administered single 

dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment. 

 

There is no specific antidote for deferasirox. Standard procedures for management of overdose may be 

indicated as well as symptomatic treatment, as medically appropriate. 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

17 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 

 
Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC03 

 

Mechanism of action 

Deferasirox is an orally active chelator that is highly selective for iron (III). It is a tridentate ligand that 

binds iron with high affinity in a 2:1 ratio. Deferasirox promotes excretion of iron, primarily in the 

faeces. Deferasirox has low affinity for zinc and copper, and does not cause constant low serum levels 

of these metals. 

 

Pharmacodynamic effects 

In an iron-balance metabolic study in iron-overloaded adult thalassaemic patients, deferasirox at daily 

doses of 10, 20 and 40 mg/kg (dispersible tablet formulation) induced the mean net excretion of 0.119, 

0.329 and 0.445 mg Fe/kg body weight/day, respectively. 

 

Clinical efficacy and safety 

Clinical efficacy studies were conducted with deferasirox dispersible tablets. 

 

Deferasirox has been investigated in 411 adult (age 16 years) and 292 paediatric patients (aged 2 to 

<16 years) with chronic iron overload due to blood transfusions. Of the paediatric patients 52 were 

aged 2 to 5 years. The underlying conditions requiring transfusion included beta-thalassaemia, sickle 

cell disease and other congenital and acquired anaemias (myelodysplastic syndromes [MDS], 

Diamond-Blackfan syndrome, aplastic anaemia and other very rare anaemias). 

 

Daily treatment with the deferasirox dispersible tablet formulation at doses of 20 and 30 mg/kg for one 

year in frequently transfused adult and paediatric patients with beta-thalassaemia led to reductions in 

indicators of total body iron; liver iron concentration was reduced by about -0.4 and -8.9 mg Fe/g liver 

(biopsy dry weight (dw)) on average, respectively, and serum ferritin was reduced by about -36 

and -926 µg/l on average, respectively. At these same doses the ratios of iron excretion: iron intake 

were 1.02 (indicating net iron balance) and 1.67 (indicating net iron removal), respectively. 

Deferasirox induced similar responses in iron-overloaded patients with other anaemias. Daily doses of 

10 mg/kg (dispersible tablet formulation) for one year could maintain liver iron and serum ferritin 

levels and induce net iron balance in patients receiving infrequent transfusions or exchange 

transfusions. Serum ferritin assessed by monthly monitoring reflected changes in liver iron 

concentration indicating that trends in serum ferritin can be used to monitor response to therapy. 

Limited clinical data (29 patients with normal cardiac function at baseline) using MRI indicate that 

treatment with deferasirox 10-30 mg/kg/day (dispersible tablet formulation) for 1 year may also 

reduce levels of iron in the heart (on average, MRI T2* increased from 18.3 to 23.0 milliseconds). 

 

The principal analysis of the pivotal comparative study in 586 patients suffering from 

beta-thalassaemia and transfusional iron overload did not demonstrate non-inferiority of deferasirox 

dispersible tablets to deferoxamine in the analysis of the total patient population. It appeared from a 

post-hoc analysis of this study that, in the subgroup of patients with liver iron concentration ≥7 mg 

Fe/g dw treated with deferasirox dispersible tablets (20 and 30 mg/kg) or deferoxamine (35 to 

≥50 mg/kg), the non-inferiority criteria were achieved. However, in patients with liver iron 

concentration <7 mg Fe/g dw treated with deferasirox dispersible tablets (5 and 10 mg/kg) or 

deferoxamine (20 to 35 mg/kg), non-inferiority was not established due to imbalance in the dosing of 

the two chelators. This imbalance occurred because patients on deferoxamine were allowed to remain 

on their pre-study dose even if it was higher than the protocol specified dose. Fifty-six patients under 

the age of 6 years participated in this pivotal study, 28 of them receiving deferasirox dispersible 

tablets. 

 



 

18 

It appeared from preclinical and clinical studies that deferasirox dispersible tablets could be as active 

as deferoxamine when used in a dose ratio of 2:1 (i.e. a dose of deferasirox dispersible tablets that is 

numerically half of the deferoxamine dose). However, this dosing recommendation was not 

prospectively assessed in the clinical studies. 

 

In addition, in patients with liver iron concentration ≥7 mg Fe/g dw with various rare anaemias or 

sickle cell disease, deferasirox dispersible tablets up to 20 and 30 mg/kg produced a decrease in liver 

iron concentration and serum ferritin comparable to that obtained in patients with beta-thalassaemia. 

 

A placebo-controlled randomised study was performed in 225 patients with MDS (Low/Int-1 risk) and 

transfusional iron overload. The results of this study suggest that there is a positive impact of 

deferasirox on event-free survival (EFS, a composite endpoint including non-fatal cardiac or liver 

events) and serum ferritin levels. The safety profile was consistent with previous studies in adult MDS 

patients. 

 

In a 5-year observational study in which 267 children aged 2 to <6 years (at enrollment) with 

transfusional haemosiderosis received deferasirox, there were no clinically meaningful differences in 

the safety and tolerability profile of Exjade in paediatric patients aged 2 to <6 years compared to the 

overall adult and older paediatric population, including increases in serum creatinine of >33% and 

above the upper limit of normal on ≥2 consecutive occasions (3.1%), and elevation of alanine 

aminotransferase (ALT) greater than 5 times the upper limit of normal (4.3%). Single events of 

increase in ALT and aspartate aminotransferase were reported in 20.0% and 8.3%, respectively, of the 

145 patients who completed the study. 
 

In a study to assess the safety of deferasirox film-coated and dispersible tablets, 173 adult and 

paediatric patients with transfusion dependent thalassaemia or myelodysplastic syndrome were treated 

for 24 weeks. A comparable safety profile for film-coated and dispersible tablets was observed. 

 

In patients with non-transfusion-dependent thalassaemia syndromes and iron overload, treatment with 

deferasirox dispersible tablets was assessed in a 1-year, randomised, double-blind, placebo-controlled 

study. The study compared the efficacy of two different deferasirox dispersible tablet regimens 

(starting doses of 5 and 10 mg/kg/day, 55 patients in each arm) and of matching placebo (56 patients). 

The study enrolled 145 adult and 21 paediatric patients. The primary efficacy parameter was the 

change in liver iron concentration (LIC) from baseline after 12 months of treatment. One of the 

secondary efficacy parameters was the change in serum ferritin between baseline and fourth quarter. 

At a starting dose of 10 mg/kg/day, deferasirox dispersible tablets led to reductions in indicators of 

total body iron. On average, liver iron concentration decreased by 3.80 mg Fe/g dw in patients treated 

with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 0.38 mg Fe/g dw in 

patients treated with placebo (p<0.001). On average, serum ferritin decreased by 222.0 µg/l in patients 

treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 115 µg/l in 

patients treated with placebo (p<0.001). 

 

5.2 Pharmacokinetic properties 
 

Absorption 

Deferasirox (dispersible tablet formulation) is absorbed following oral administration with a median 

time to maximum plasma concentration (tmax) of about 1.5 to 4 hours. The absolute bioavailability 

(AUC) of deferasirox (dispersible tablet formulation) is about 70% compared to an intravenous dose. 

Total exposure (AUC) was approximately doubled when taken along with a high-fat breakfast (fat 

content >50% of calories) and by about 50% when taken along with a standard breakfast. The 

bioavailability (AUC) of deferasirox was moderately (approx. 13–25%) elevated when taken 

30 minutes before meals with normal or high fat content. 

 

Distribution 

Deferasirox is highly (99%) protein bound to plasma proteins, almost exclusively serum albumin, and 

has a small volume of distribution of approximately 14 litres in adults. 

 



 

19 

Biotransformation 

Glucuronidation is the main metabolic pathway for deferasirox, with subsequent biliary excretion. 

Deconjugation of glucuronidates in the intestine and subsequent reabsorption (enterohepatic recycling) 

is likely to occur: in a healthy volunteer study, the administration of cholestyramine after a single dose 

of deferasirox resulted in a 45% decrease in deferasirox exposure (AUC). 

 

Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3. CYP450-catalysed 

(oxidative) metabolism of deferasirox appears to be minor in humans (about 8%). No inhibition of 

deferasirox metabolism by hydroxyurea was observed in vitro. 

 

Elimination 

Deferasirox and its metabolites are primarily excreted in the faeces (84% of the dose). Renal excretion 

of deferasirox and its metabolites is minimal (8% of the dose). The mean elimination half-life (t1/2) 

ranged from 8 to 16 hours. The transporters MRP2 and MXR (BCRP) are involved in the biliary 

excretion of deferasirox. 

 

Linearity / non-linearity 

The Cmax and AUC0-24h of deferasirox increase approximately linearly with dose under steady-state 

conditions. Upon multiple dosing exposure increased by an accumulation factor of 1.3 to 2.3. 

 

Characteristics in patients 

Paediatric patients 

The overall exposure of adolescents (12 to ≤17 years) and children (2 to <12 years) to deferasirox after 

single and multiple doses was lower than that in adult patients. In children younger than 6 years old 

exposure was about 50% lower than in adults. Since dosing is individually adjusted according to 

response this is not expected to have clinical consequences. 

 

Gender 

Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males. 

Since dosing is individually adjusted according to response this is not expected to have clinical 

consequences. 

 

Elderly patients 

The pharmacokinetics of deferasirox have not been studied in elderly patients (aged 65 or older). 

 

Renal or hepatic impairment 

The pharmacokinetics of deferasirox have not been studied in patients with renal impairment. The 

pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the 

upper limit of the normal range. 

 

In a clinical study using single doses of 20 mg/kg deferasirox dispersible tablets, the average exposure 

was increased by 16% in subjects with mild hepatic impairment (Child-Pugh Class A) and by 76% in 

subjects with moderate hepatic impairment (Child-Pugh Class B) compared to subjects with normal 

hepatic function. The average Cmax of deferasirox in subjects with mild or moderate hepatic 

impairment was increased by 22%. Exposure was increased 2.8-fold in one subject with severe hepatic 

impairment (Child-Pugh Class C) (see sections 4.2 and 4.4). 

 

5.3 Preclinical safety data 
 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential. The main findings were 

kidney toxicity and lens opacity (cataracts). Similar findings were observed in neonatal and juvenile 

animals. The kidney toxicity is considered mainly due to iron deprivation in animals that were not 

previously overloaded with iron. 

 



 

20 

Tests of genotoxicity in vitro were negative (Ames test, chromosomal aberration test) while 

deferasirox caused formation of micronuclei in vivo in the bone marrow, but not liver, of 

non-iron-loaded rats at lethal doses. No such effects were observed in iron-preloaded rats. Deferasirox 

was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/- heterozygous 

mice in a 6-month study. 

 

The potential for toxicity to reproduction was assessed in rats and rabbits. Deferasirox was not 

teratogenic, but caused increased frequency of skeletal variations and stillborn pups in rats at high 

doses that were severely toxic to the non-iron-overloaded mother. Deferasirox did not cause other 

effects on fertility or reproduction. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Lactose monohydrate 

Crospovidone type A 

Cellulose, microcrystalline 

Povidone 

Sodium laurilsulfate 

Silica, colloidal anhydrous 

Magnesium stearate 

 

6.2 Incompatibilities 
 

Dispersion in carbonated drinks or milk is not recommended due to foaming and slow dispersion, 

respectively. 

 

6.3 Shelf life 
 

3 years 

 

6.4 Special precautions for storage 
 

Store in the original package in order to protect from moisture. 

 

6.5 Nature and contents of container 
 

PVC/PE/PVDC/Aluminium blisters. 

 

EXJADE 125 mg dispersible tablets 

Packs containing 28, 84 or 252 dispersible tablets. 

 

EXJADE 250 mg dispersible tablets 

Packs containing 28, 84 or 252 dispersible tablets. 

 

EXJADE 500 mg dispersible tablets 

Unit packs containing 28, 84 or 252 dispersible tablets and multipacks containing 294 (3 packs of 

98) dispersible tablets. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal 
 

No special requirements. 

 



 

21 

 

7. MARKETING AUTHORISATION HOLDER 
 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EXJADE 125 mg dispersible tablets 

EU/1/06/356/001 

EU/1/06/356/002 

EU/1/06/356/007 

 

EXJADE 250 mg dispersible tablets 

EU/1/06/356/003 

EU/1/06/356/004 

EU/1/06/356/008 

 

EXJADE 500 mg dispersible tablets 

EU/1/06/356/005 

EU/1/06/356/006 

EU/1/06/356/009 

EU/1/06/356/010 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 28 August 2006 

Date of latest renewal: 18 April 2016 

 

 

10. DATE OF REVISION OF THE TEXT 
 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu 

http://www.ema.europa.eu/


 

22 

This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

 

1. NAME OF THE MEDICINAL PRODUCT 
 

EXJADE 90 mg film-coated tablets 

EXJADE 180 mg film-coated tablets 

EXJADE 360 mg film-coated tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

EXJADE 90 mg film-coated tablets 

Each film-coated tablet contains 90 mg deferasirox. 

 

EXJADE 180 mg film-coated tablets 

Each film-coated tablet contains 180 mg deferasirox. 

 

EXJADE 360 mg film-coated tablets 

Each film-coated tablet contains 360 mg deferasirox. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Film-coated tablet 

 

EXJADE 90 mg film-coated tablets 

Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face 

and 90 on the other). Approximate tablet dimensions 10.7 mm x 4.2 mm. 

 

EXJADE 180 mg film-coated tablets 

Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one 

face and 180 on the other). Approximate tablet dimensions 14 mm x 5.5 mm. 

 

EXJADE 360 mg film-coated tablets 

Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face 

and 360 on the other). Approximate tablet dimensions 17 mm x 6.7 mm. 

 

 

  



 

23 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

EXJADE is indicated 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. 
 

EXJADE is also indicated for the treatment of chronic iron overload due to blood transfusions when 

deferoxamine therapy is contraindicated or inadequate in the following patient groups: 

- in paediatric patients with beta thalassaemia major with iron overload due to frequent blood 

transfusions (7 ml/kg/month of packed red blood cells) aged 2 to 5 years, 

- in adult and paediatric patients with beta thalassaemia major with iron overload due to 

infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and 

older, 

- in adult and paediatric patients with other anaemias aged 2 years and older. 
 

EXJADE is also indicated for the treatment of chronic iron overload requiring chelation therapy when 

deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent 

thalassaemia syndromes aged 10 years and older. 

 

4.2 Posology and method of administration 
 

Treatment with EXJADE should be initiated and maintained by physicians experienced in the 

treatment of chronic iron overload. 

 

Posology 

 

Transfusional iron overload 

 

It is recommended that treatment be started after the transfusion of approximately 20 units (about 

100 ml/kg) of packed red blood cells (PRBC) or when there is evidence from clinical monitoring that 

chronic iron overload is present (e.g. serum ferritin >1,000 µg/l). Doses (in mg/kg) must be calculated 

and rounded to the nearest whole tablet size. 

 

The goals of iron chelation therapy are to remove the amount of iron administered in transfusions and, 

as required, to reduce the existing iron burden. 

 

Caution should be taken during chelation therapy to minimise the risk of overchelation in all patients 

(see section 4.4). 

 

EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible 

tablet formulation (see section 5.2). In case of switching from dispersible tablets to film-coated tablets, 

the dose of the film-coated tablets should be 30% lower than the dose of the dispersible tablets, 

rounded to the nearest whole tablet. 

 

The corresponding doses for the different formulations are shown in the table below. 

 



 

24 

Table 1 Recommended doses for transfusional iron overload 

 

 Film-coated 

tablets/granules 

Dispersible tablets Transfusions  Serum 

ferritin 

Starting dose 14 mg/kg/day 20 mg/kg/day After 20 units 

(about 100 ml/kg) 

of PRBC 

or >1,000 µg/l 

Alternative 

starting doses 

21 mg/kg/day 30 mg/kg/day >14 ml/kg/month 

of PRBC (approx. 

>4 units/month 

for an adult) 

  

 7 mg/kg/day 10 mg/kg/day <7 ml/kg/month 

of PRBC (approx. 

<2 units/month 

for an adult) 

  

For patients 

well managed 

on 

deferoxamine 

One third of 

deferoxamine dose 

Half of 

deferoxamine dose 

   

Monitoring     Monthly 

Target range     500-1,000 µg/l 

      

Adjustment 

steps 
(every 

3-6 months) 

Increase   >2,500 µg/l 

3.5 - 7 mg/kg/day 

Up to 28 mg/kg/day 

5-10 mg/kg/day 

Up to 40 mg/kg/day 

   

Decrease    

3.5 - 7 mg/kg/day 5-10 mg/kg/day   <2,500 µg/l 

In patients treated 

with doses 

>21 mg/kg/day 

In patients treated 

with doses 

>30 mg/kg/day 

   

- When target is reached   500-1,000 µg/l 

Maximum 

dose 

28 mg/kg/day 40 mg/kg/day    

Consider 

interruption 

    <500 µg/l 

 

  



 

25 

Starting dose 

The recommended initial daily dose of EXJADE film-coated tablets is 14 mg/kg body weight. 

 

An initial daily dose of 21 mg/kg may be considered for patients who require reduction of elevated 

body iron levels and who are also receiving more than 14 ml/kg/month of packed red blood cells 

(approximately >4 units/month for an adult). 

 

An initial daily dose of 7 mg/kg may be considered for patients who do not require reduction of body 

iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells 

(approximately <2 units/month for an adult). The patient’s response must be monitored and a dose 

increase should be considered if sufficient efficacy is not obtained (see section 5.1). 

 

For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE 

film-coated tablets that is numerically one third that of the deferoxamine dose could be considered 

(e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be 

transferred to a starting daily dose of 14 mg/kg/day of EXJADE film-coated tablets). When this results 

in a daily dose less than 14 mg/kg body weight, the patient’s response must be monitored and a dose 

increase should be considered if sufficient efficacy is not obtained (see section 5.1). 

 

Dose adjustment 

It is recommended that serum ferritin be monitored every month and that the dose of EXJADE be 

adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin. Dose adjustments 

may be made in steps of 3.5 to 7 mg/kg and are to be tailored to the individual patient’s response and 

therapeutic goals (maintenance or reduction of iron burden). In patients not adequately controlled with 

doses of 21 mg/kg (e.g. serum ferritin levels persistently above 2,500 µg/l and not showing a 

decreasing trend over time), doses of up to 28 mg/kg may be considered. The availability of long-term 

efficacy and safety data from clinical studies conducted with EXJADE dispersible tablets used at 

doses above 30 mg/kg is currently limited (264 patients followed for an average of 1 year after dose 

escalation). If only very poor haemosiderosis control is achieved at doses up to 21 mg/kg, a further 

increase (to a maximum of 28 mg/kg) may not achieve satisfactory control, and alternative treatment 

options may be considered. If no satisfactory control is achieved at doses above 21 mg/kg, treatment at 

such doses should not be maintained and alternative treatment options should be considered whenever 

possible. Doses above 28 mg/kg are not recommended because there is only limited experience with 

doses above this level (see section 5.1). 

 

In patients treated with doses greater than 21 mg/kg, dose reductions in steps of 3.5 to 7 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 1,000 µg/l), dose reductions in steps of 3.5 to 7 mg/kg should be 

considered to maintain serum ferritin levels within the target range and to minimise the risk of 

overchelation. If serum ferritin falls consistently below 500 µg/l, an interruption of treatment should 

be considered (see section 4.4). 

 

Non-transfusion-dependent thalassaemia syndromes 

 

Chelation therapy should only be initiated when there is evidence of iron overload (liver iron 

concentration [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin consistently >800 µg/l). LIC is the 

preferred method of iron overload determination and should be used wherever available. Caution 

should be taken during chelation therapy to minimise the risk of overchelation in all patients (see 

section 4.4). 

 

EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible 

tablet formulation (see section 5.2). In case of switching from dispersible tablets to film-coated tablets, 

the dose of the film-coated tablets should be 30% lower than the dose of the dispersible tablets, 

rounded to the nearest whole tablet. 

 

The corresponding doses for the different formulations are shown in the table below. 



 

26 

 

Table 2 Recommended doses for non-transfusion-dependent thalassaemia syndromes 

 

 Film-coated 

tablets/granules 

Dispersible 

tablets 

Liver iron 

concentration 

(LIC)* 

 Serum 

ferritin 

Starting dose 7 mg/kg/day 10 mg/kg/day ≥5 mg Fe/g dw or >800 µg/l 

Monitoring     Monthly 

Adjustment 

steps 
(every 

3-6 months) 

Increase ≥7 mg Fe/g dw or >2,000 µg/l 

3.5 - 7 mg/kg/day 5-10 mg/kg/day    

Decrease <7 mg Fe/g dw or ≤2,000 µg/l 

3.5 - 7 mg/kg/day 5-10 mg/kg/day    

Maximum 

dose 

14 mg/kg/day 20 mg/kg/day    

 7 mg/kg/day 10 mg/kg/day    

 For adults not assessed and ≤2,000 µg/l 
 For paediatric patients    

Interruption   <3 mg Fe/g dw or <300 µg/l 

Retreatment   Not recommended 

*LIC is the preferred method of iron overload determination. 

 

Starting dose 

The recommended initial daily dose of EXJADE film-coated tablets in patients with 

non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight. 

 

Dose adjustment 

It is recommended that serum ferritin be monitored every month to assess the patient’s response to 

therapy and to minimise the risk of overchelation (see section 4.4). After every 3 to 6 months of 

treatment, a dose increase in increments of 3.5 to 7 mg/kg should be considered if the patient’s LIC is 

≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and 

the patient is tolerating the medicinal product well. Doses above 14 mg/kg are not recommended 

because there is no experience with doses above this level in patients with non-transfusion-dependent 

thalassaemia syndromes. 

 

In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 

7 mg/kg. 

 

For patients in whom the dose was increased to >7 mg/kg, dose reduction to 7 mg/kg or less is 

recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l. 

 

Treatment cessation 

Once a satisfactory body iron level has been achieved (LIC <3 mg Fe/g dw or serum ferritin 

<300 µg/l), treatment should be stopped. There are no data available on the retreatment of patients 

who reaccumulate iron after having achieved a satisfactory body iron level and therefore retreatment 

cannot be recommended. 

 

Special populations 

 

Elderly patients (≥65 years of age) 

The dosing recommendations for elderly patients are the same as described above. In clinical studies, 

elderly patients experienced a higher frequency of adverse reactions than younger patients (in 

particular, diarrhoea) and should be monitored closely for adverse reactions that may require a dose 

adjustment. 

 



 

27 

Paediatric population 

Transfusional iron overload: 

The dosing recommendations for paediatric patients aged 2 to 17 years with transfusional iron 

overload are the same as for adult patients (see section 4.2). It is recommended that serum ferritin be 

monitored every month to assess the patient’s response to therapy and to minimise the risk of 

overchelation (see section 4.4). Changes in weight of paediatric patients over time must be taken into 

account when calculating the dose. 

 

In children with transfusional iron overload 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. 

 

Non-transfusion-dependent thalassaemia syndromes: 

In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not 

exceed 7 mg/kg. In these patients, closer monitoring of LIC and serum ferritin is essential to avoid 

overchelation (see section 4.4). In addition to monthly serum ferritin assessments, LIC should be 

monitored every three months when serum ferritin is ≤800 µg/l. 

 

Children from birth to 23 months: 

The safety and efficacy of EXJADE in children from birth to 23 months of age have not 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 is not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In 

patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be considerably 

reduced followed by progressive increase up to a limit of 50% (see sections 4.4 and 5.2), and EXJADE 

must be used with caution in such patients. 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. 

 

The film-coated tablets should be swallowed whole with some water. For patients who are unable to 

swallow whole tablets, the film-coated tablets may be crushed and administered by sprinkling the full 

dose onto soft food, e.g. yogurt or apple sauce (pureed apple). The dose should be immediately and 

completely consumed, and not stored for future use. 
 

The film-coated tablets should be taken once a day, preferably at the same time each day, and may be 

taken on an empty stomach or with a light meal (see sections 4.5 and 5.2). 

 

4.3 Contraindications 
 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

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. 

 



 

28 

4.4 Special warnings and precautions for use 
 

Renal function 

 

Deferasirox has been studied only in patients with baseline serum creatinine within the 

age-appropriate normal range. 

 
During clinical studies, 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. In some cases, only a stabilisation of the 

serum creatinine values has been observed after dose reduction. Cases of acute renal failure have been 

reported following post-marketing use of deferasirox (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 

deferasirox and/or low rates of transfusion (<7 ml/kg/month of packed red blood cells or 

<2 units/month for an adult). While no increase in renal adverse events was observed after dose 

escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk 

of renal adverse events with film-coated tablet doses above 21 mg/kg cannot be excluded. 

 

It is recommended that serum creatinine be assessed in duplicate before initiating therapy. Serum 

creatinine, creatinine clearance (estimated with the Cockcroft-Gault or MDRD formula in adults and 

with the Schwartz formula in children) and/or plasma cystatin C levels should be monitored prior to 

therapy, weekly in the first month after initiation or modification of therapy with EXJADE 

(including switch of formulation), and monthly thereafter. Patients with pre-existing renal 

conditions and patients who are receiving medicinal products that depress renal function may be more 

at risk of complications. Care should be taken to maintain adequate hydration in patients who develop 

diarrhoea or vomiting. 

 

There have been post-marketing reports of metabolic acidosis occurring during treatment with 

deferasirox. The majority of these patients had renal impairment, renal tubulopathy (Fanconi 

syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication. Acid-base 

balance should be monitored as clinically indicated in these populations. Interruption of EXJADE 

therapy should be considered in patients who develop metabolic acidosis. 

 

Post-marketing cases of severe forms of renal tubulopathy (such as Fanconi syndrome) and renal 

failure associated with changes in consciousness in the context of hyperammonaemic encephalopathy 

have been reported in patients treated with deferasirox, mainly in children. It is recommended that 

hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who 

develop unexplained changes in mental status while on Exjade therapy. 

 



 

29 

Table 3 Dose adjustment and interruption of treatment for renal monitoring 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Treatment may be reinitiated depending on the individual clinical circumstances. 

 

Dose reduction or interruption may be also considered if abnormalities occur in levels of markers of 

renal tubular function and/or as clinically indicated: 

• Proteinuria (test should be performed prior to therapy and monthly thereafter) 

• Glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, 

phosphaturia, aminoaciduria (monitor as needed). 

Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated 

with EXJADE. 

 

Patients should be referred to a renal specialist, and further specialised investigations (such as renal 

biopsy) may be considered if the following occur despite dose reduction and interruption: 

• Serum creatinine remains significantly elevated and 

• Persistent abnormality in another marker of renal function (e.g. proteinuria, Fanconi Syndrome). 

 

Hepatic function 
 

Liver function test elevations have been observed in patients treated with deferasirox. Post-marketing 

cases of hepatic failure, some of which were fatal, have been reported. Severe forms associated with 

changes in consciousness in the context of hyperammonaemic encephalopathy, may occur in patients 

treated with deferasirox, particularly in children. It is recommended that hyperammonaemic 

encephalopathy be considered and ammonia levels measured in patients who develop unexplained 

changes in mental status while on Exjade therapy. Care should be taken to maintain adequate 

hydration in patients who experience volume-depleting events (such as diarrhoea or vomiting), 

particularly in children with acute illness. Most reports of hepatic failure involved patients with 

significant comorbidities including pre-existing chronic liver conditions (including cirrhosis and 

hepatitis C) and multi-organ failure. The role of deferasirox as a contributing or aggravating factor 

cannot be excluded (see section 4.8). 

 

 Serum creatinine  Creatinine clearance 

Before initiation of 

therapy 

Twice (2x) and Once (1x) 

Contraindicated   <60 ml/min 

Monitoring    

- First month after 

start of therapy or 

dose modification 

(including switch 

of formulation) 

Weekly and Weekly 

- Thereafter Monthly and Monthly 

Reduction of daily dose by 7 mg/kg/day (film-coated tablet formulation), 

if following renal parameters are observed at two consecutive visits and cannot be attributed to 

other causes 

Adult patients >33% above pre-

treatment average 

and Decreases <LLN* 

(<90 ml/min) 

Paediatric patients > age appropriate 

ULN**  

and/or Decreases <LLN* 

(<90 ml/min) 

After dose reduction, interrupt treatment, if 

Adult and paediatric Remains >33% above 

pre-treatment average 

and/or Decreases <LLN* 

(<90 ml/min) 

*LLN: lower limit of the normal range 

**ULN: upper limit of the normal range 

 



 

30 

It is recommended that serum transaminases, bilirubin and alkaline phosphatase be checked before the 

initiation of treatment, every 2 weeks during the first month and monthly thereafter. If there is a 

persistent and progressive increase in serum transaminase levels that cannot be attributed to other 

causes, EXJADE should be interrupted. Once the cause of the liver function test abnormalities has 

been clarified or after return to normal levels, cautious re-initiation of treatment at a lower dose 

followed by gradual dose escalation may be considered. 

 

EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see 

section 5.2). 

 

Table 4 Summary of safety monitoring recommendations 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

In patients with a short life expectancy (e.g. high-risk myelodysplastic syndromes), especially when 

co-morbidities could increase the risk of adverse events, the benefit of EXJADE might be limited and 

may be inferior to risks. As a consequence, treatment with EXJADE is not recommended in these 

patients. 

 

Caution should be used in elderly patients due to a higher frequency of adverse reactions (in particular, 

diarrhoea). 

 

Data in children with non-transfusion-dependent thalassaemia are very limited (see section 5.1). As a 

consequence, EXJADE therapy should be closely monitored to detect adverse reactions and to follow 

iron burden in the paediatric population. In addition, before treating heavily iron-overloaded children 

with non-transfusion-dependent thalassaemia with EXJADE, the physician should be aware that the 

consequences of long-term exposure in such patients are currently not known. 

 

Test Frequency 

Serum creatinine In duplicate prior to therapy. 

Weekly during first month of therapy or 

after dose modification (including switch 

of formulation). 

Monthly thereafter. 

Creatinine clearance and/or plasma 

cystatin C 

Prior to therapy. 

Weekly during first month of therapy or 

after dose modification (including switch 

of formulation). 

Monthly thereafter. 

Proteinuria Prior to therapy. 

Monthly thereafter. 

Other markers of renal tubular function 

(such as glycosuria in non-diabetics and 

low levels of serum potassium, 

phosphate, magnesium or urate, 

phosphaturia, aminoaciduria) 

As needed. 

Serum transaminases, bilirubin, alkaline 

phosphatase 

Prior to therapy. 

Every 2 weeks during first month of 

therapy. 

Monthly thereafter. 

Auditory and ophthalmic testing Prior to therapy. 

Annually thereafter. 

Body weight, height and sexual 

development 

Prior to therapy. 

Annually in paediatric patients. 

 



 

31 

Gastrointestinal disorders 

Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children 

and adolescents, receiving deferasirox. Multiple ulcers have been observed in some patients (see 

section 4.8). There have been reports of ulcers complicated with digestive perforation. Also, there 

have been reports of fatal gastrointestinal haemorrhages, especially in elderly patients who had 

haematological malignancies and/or low platelet counts. Physicians and patients should remain alert 

for signs and symptoms of gastrointestinal ulceration and haemorrhage during EXJADE therapy. In 

case of gastrointestinal ulceration or haemorrhage, EXJADE should be discontinued and additional 

evaluation and treatment must be promptly initiated. Caution should be exercised in patients who are 

taking EXJADE in combination with substances that have known ulcerogenic potential, such as 

NSAIDs, corticosteroids, or oral bisphosphonates, in patients receiving anticoagulants and in patients 

with platelet counts below 50,000/mm3 (50 x 109/l) (see section 4.5). 

 

Skin disorders 

Skin rashes may appear during EXJADE treatment. The rashes resolve spontaneously in most cases. 

When interruption of treatment may be necessary, treatment may be reintroduced after resolution of 

the rash, at a lower dose followed by gradual dose escalation. In severe cases this reintroduction could 

be conducted in combination with a short period of oral steroid administration. Severe cutaneous 

adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis 

(TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be life-

threatening or fatal, have been reported. If any SCAR is suspected, EXJADE should be discontinued 

immediately and should not be reintroduced. At the time of prescription, patients should be advised of 

the signs and symptoms of severe skin reactions, and be closely monitored. 

 

Hypersensitivity reactions 

Cases of serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported 

in patients receiving deferasirox, with the onset of the reaction occurring in the majority of cases 

within the first month of treatment (see section 4.8). If such reactions occur, EXJADE should be 

discontinued and appropriate medical intervention instituted. Deferasirox should not be reintroduced 

in patients who have experienced a hypersensitivity reaction due to the risk of anaphylactic shock (see 

section 4.3). 

 

Vision and hearing 

Auditory (decreased hearing) and ocular (lens opacities) disturbances have been reported (see section 

4.8). Auditory and ophthalmic testing (including fundoscopy) is recommended before the start of 

treatment and at regular intervals thereafter (every 12 months). If disturbances are noted during the 

treatment, dose reduction or interruption may be considered. 

 

Blood disorders 

There have been post-marketing reports of leukopenia, thrombocytopenia or pancytopenia (or 

aggravation of these cytopenias) and of aggravated anaemia in patients treated with deferasirox. Most 

of these patients had pre-existing haematological disorders that are frequently associated with bone 

marrow failure. However, a contributory or aggravating role cannot be excluded. Interruption of 

treatment should be considered in patients who develop unexplained cytopenia. 

 

Other considerations 

Monthly monitoring of serum ferritin is recommended in order to assess the patient’s response to 

therapy and to avoid overchelation (see section 4.2). Dose reduction or closer monitoring of renal and 

hepatic function, and serum ferritin levels are recommended during periods of treatments with high 

doses and when serum ferritin levels are close to the target range. If serum ferritin falls consistently 

below 500 µg/l (in transfusional iron overload) or below 300 µg/l (in non-transfusion-dependent 

thalassaemia syndromes), an interruption of treatment should be considered. 

 

The results of the tests for serum creatinine, serum ferritin and serum transaminases should be 

recorded and regularly assessed for trends. 

 



 

32 

In two clinical studies, growth and sexual development of paediatric patients treated with deferasirox 

for up to 5 years were not affected (see section 4.8). However, as a general precautionary measure in 

the management of paediatric patients with transfusional iron overload, body weight, height and 

sexual development should be monitored prior to therapy and at regular intervals (every 12 months). 

 

Cardiac dysfunction is a known complication of severe iron overload. Cardiac function should be 

monitored in patients with severe iron overload during long-term treatment with EXJADE. 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

The safety of deferasirox in combination with other iron chelators has not been established. Therefore, 

it must not be combined with other iron chelator therapies (see section 4.3). 

 

Interaction with food 

The Cmax of deferasirox film-coated tablets was increased (by 29%) when taken with a high-fat meal. 

EXJADE film-coated tablets may be taken either on an empty stomach or with a light meal, preferably 

at the same time each day (see sections 4.2 and 5.2). 

 

Agents that may decrease EXJADE systemic exposure 

Deferasirox metabolism depends on UGT enzymes. In a healthy volunteer study, the concomitant 

administration of deferasirox (single dose of 30 mg/kg, dispersible tablet formulation) and the potent 

UGT inducer, rifampicin, (repeated dose of 600 mg/day) resulted in a decrease of deferasirox exposure 

by 44% (90% CI: 37% - 51%). Therefore, the concomitant use of EXJADE with potent UGT inducers 

(e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may result in a decrease in 

EXJADE efficacy. The patient’s serum ferritin should be monitored during and after the combination, 

and the dose of EXJADE adjusted if necessary. 

 

Cholestyramine significantly reduced the deferasirox exposure in a mechanistic study to determine the 

degree of enterohepatic recycling (see section 5.2). 

 

Interaction with midazolam and other agents metabolised by CYP3A4 

In a healthy volunteer study, the concomitant administration of deferasirox dispersible tablets and 

midazolam (a CYP3A4 probe substrate) resulted in a decrease of midazolam exposure by 17% (90% 

CI: 8% - 26%). In the clinical setting, this effect may be more pronounced. Therefore, due to a 

possible decrease in efficacy, caution should be exercised when deferasirox is combined with 

substances metabolised through CYP3A4 (e.g. ciclosporin, simvastatin, hormonal contraceptive 

agents, bepridil, ergotamine). 

 

Interaction with repaglinide and other agents metabolised by CYP2C8 

In a healthy volunteer study, the concomitant administration of deferasirox as a moderate CYP2C8 

inhibitor (30 mg/kg daily, dispersible tablet formulation), with repaglinide, a CYP2C8 substrate, given 

as a single dose of 0.5 mg, increased repaglinide AUC and Cmax about 2.3-fold (90% CI [2.03-2.63]) 

and 1.6-fold (90% CI [1.42-1.84]), respectively. Since the interaction has not been established with 

dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should 

be avoided. If the combination appears necessary, careful clinical and blood glucose monitoring 

should be performed (see section 4.4). An interaction between deferasirox and other CYP2C8 

substrates like paclitaxel cannot be excluded. 

 



 

33 

Interaction with theophylline and other agents metabolised by CYP1A2 

In a healthy volunteer study, the concomitant administration of deferasirox as a CYP1A2 inhibitor 

(repeated dose of 30 mg/kg/day, dispersible tablet formulation) and the CYP1A2 substrate 

theophylline (single dose of 120 mg) resulted in an increase of theophylline AUC by 84% (90% CI: 

73% to 95%). The single dose Cmax was not affected, but an increase of theophylline Cmax is expected 

to occur with chronic dosing. Therefore, the concomitant use of deferasirox with theophylline is not 

recommended. If deferasirox and theophylline are used concomitantly, monitoring of theophylline 

concentration and theophylline dose reduction should be considered. An interaction between 

deferasirox and other CYP1A2 substrates cannot be excluded. For substances that are predominantly 

metabolised by CYP1A2 and that have a narrow therapeutic index (e.g. clozapine, tizanidine), the 

same recommendations apply as for theophylline. 

 

Other information 

The concomitant administration of deferasirox and aluminium-containing antacid preparations has not 

been formally studied. Although deferasirox has a lower affinity for aluminium than for iron, it is not 

recommended to take deferasirox tablets with aluminium-containing antacid preparations. 

 

The concomitant administration of deferasirox with substances that have known ulcerogenic potential, 

such as NSAIDs (including acetylsalicylic acid at high dosage), corticosteroids or oral 

bisphosphonates may increase the risk of gastrointestinal toxicity (see section 4.4). The concomitant 

administration of deferasirox with anticoagulants may also increase the risk of gastrointestinal 

haemorrhage. Close clinical monitoring is required when deferasirox is combined with these 

substances. 

 

Concomitant administration of deferasirox and busulfan resulted in an increase of busulfan exposure 

(AUC), but the mechanism of the interaction remains unclear. If possible, evaluation of the 

pharmacokinetics (AUC, clearance) of a busulfan test dose should be performed to allow dose 

adjustment. 

 

4.6 Fertility, pregnancy and lactation 
 

Pregnancy 

No clinical data on exposed pregnancies are available for deferasirox. Studies in animals have shown 

some reproductive toxicity at maternally toxic doses (see section 5.3). The potential risk for humans is 

unknown. 

 

As a precaution, it is recommended that EXJADE is not used during pregnancy unless clearly 

necessary. 

 

EXJADE may decrease the efficacy of hormonal contraceptives (see section 4.5). Women of 

childbearing potential are recommended to use additional or alternative non-hormonal methods of 

contraception when using EXJADE. 

 

Breast-feeding 

In animal studies, deferasirox was found to be rapidly and extensively secreted into maternal milk. No 

effect on the offspring was noted. It is not known if deferasirox is secreted into human milk. 

Breast-feeding while taking EXJADE is not recommended. 

 

Fertility 

No fertility data is available for humans. In animals, no adverse effects on male or female fertility 

were found (see section 5.3). 

 

  



 

34 

4.7 Effects on ability to drive and use machines 
 

EXJADE has minor influence on the ability to drive and use machines. Patients experiencing the 

uncommon adverse reaction of dizziness should exercise caution when driving or operating machines 

(see section 4.8). 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

The most frequent reactions reported during chronic treatment in clinical studies conducted with 

deferasirox dispersible tablets 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. These reactions are 

dose-dependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is 

continued. 

 

During clinical studies dose-dependent increases in serum creatinine occurred in about 36% of 

patients, though most remained within the normal range. Decreases in mean creatinine clearance have 

been observed in both paediatric and adult patients with beta-thalassemia and iron overload during the 

first year of treatment, but there is evidence that this does not decrease further in subsequent years of 

treatment. Elevations of liver transaminases have been reported. Safety monitoring schedules for renal 

and liver parameters are recommended. Auditory (decreased hearing) and ocular (lens opacities) 

disturbances are uncommon, and yearly examinations are also recommended (see section 4.4). 

 

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic 

epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) 

have been reported with the use of EXJADE (see section 4.4). 
 

Tabulated list of adverse reactions 

Adverse reactions are ranked below using the following convention: very common (≥1/10); common 

(≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 

(<1/10,000); not known (cannot be estimated from the available data). Within each frequency 

grouping, adverse reactions are presented in order of decreasing seriousness. 
 

  



 

35 

Table 5 

 

Blood and lymphatic system disorders 

 Not known: Pancytopenia1, thrombocytopenia1, anaemia aggravated1, 
neutropenia1 

Immune system disorders 

 Not known: Hypersensitivity reactions (including anaphylactic reactions and 

angioedema)1 

Metabolism and nutrition disorders 

 Not known: Metabolic acidosis1 

Psychiatric disorders 

 Uncommon: Anxiety, sleep disorder 

Nervous system disorders 

 Common: Headache 

 Uncommon: Dizziness 

Eye disorders 

 Uncommon: Cataract, maculopathy 

 Rare: Optic neuritis 

Ear and labyrinth disorders 

 Uncommon: Deafness 

Respiratory, thoracic and mediastinal disorders 

 Uncommon: Laryngeal pain 

Gastrointestinal disorders 

 Common: Diarrhoea, constipation, vomiting, nausea, abdominal pain, 

abdominal distension, dyspepsia 

 Uncommon: Gastrointestinal haemorrhage, gastric ulcer (including multiple 

ulcers), duodenal ulcer, gastritis 

 Rare: Oesophagitis 

 Not known: Gastrointestinal perforation1, acute pancreatitis1 

Hepatobiliary disorders 

 Common: Transaminases increased 

 Uncommon: Hepatitis, cholelithiasis 

 Not known: Hepatic failure1, 2 

Skin and subcutaneous tissue disorders 

 Common: Rash, pruritus 

 Uncommon: Pigmentation disorder 

 Rare: Drug reaction with eosinophilia and systemic symptoms (DRESS) 

 Not known: Stevens-Johnson syndrome1, hypersensitivity vasculitis1, urticaria1, 

erythema multiforme1, alopecia1, toxic epidermal necrolysis (TEN)1 

Renal and urinary disorders 

 Very common: Blood creatinine increased 

 Common: Proteinuria 

 Uncommon: Renal tubular disorder2 (acquired Fanconi syndrome), glycosuria 

 Not known: Acute renal failure1, 2, tubulointerstitial nephritis1, nephrolithiasis1, 

renal tubular necrosis1 

General disorders and administration site conditions 

 Uncommon: Pyrexia, oedema, fatigue 
1 Adverse reactions reported during post-marketing experience. These are derived from 

spontaneous reports for which it is not always possible to reliably establish frequency or a 

causal relationship to exposure to the medicinal product. 
2 Severe forms associated with changes in consciousness in the context of hyperammonaemic 

encephalopathy have been reported. 

 



 

36 

Description of selected adverse reactions 

Gallstones and related biliary disorders were reported in about 2% of patients. Elevations of liver 

transaminases were reported as an adverse reaction in 2% of patients. Elevations of transaminases 

greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon 

(0.3%). During post-marketing experience, hepatic failure, sometimes fatal, has been reported with 

deferasirox (see section 4.4). There have been post-marketing reports of metabolic acidosis. The 

majority of these patients had renal impairment, renal tubulopathy (Fanconi syndrome) or diarrhoea, 

or conditions where acid-base imbalance is a known complication (see section 4.4). Cases of serious 

acute pancreatitis were observed without documented underlying biliary conditions. As with other iron 

chelator treatment, high-frequency hearing loss and lenticular opacities (early cataracts) have been 

uncommonly observed in patients treated with deferasirox (see section 4.4). 

 

Creatinine clearance in transfusional iron overload 

In a retrospective meta-analysis of 2,102 adult and paediatric beta-thalassaemia patients with 

transfusional iron overload treated with deferasirox dispersible tablets in two randomised and four 

open label studies of up to five years’ duration, a mean creatinine clearance decrease of 13.2% in adult 

patients (95% CI: -14.4% to -12.1%; n=935) and 9.9% (95% CI: -11.1% to -8.6%; n=1,142) in 

paediatric patients was observed during the first year of treatment. In 250 patients who were followed 

for up to five years, no further decrease in mean creatinine clearance levels was observed. 

 

Clinical study in patients with non-transfusion-dependent thalassaemia syndromes 

In a 1-year study in patients with non-transfusion-dependent thalassaemia syndromes and iron 

overload (dispersible tablets at a dose of 10 mg/kg/day), diarrhoea (9.1%), rash (9.1%), and nausea 

(7.3%) were the most frequent study drug-related adverse events. Abnormal serum creatinine and 

creatinine clearance values were reported in 5.5% and 1.8% of patients, respectively. Elevations of 

liver transaminases greater than 2 times the baseline and 5 times the upper limit of normal were 

reported in 1.8% of patients. 

 

Paediatric population 

In two clinical studies, growth and sexual development of paediatric patients treated with deferasirox 

for up to 5 years were not affected (see section 4.4). 

 
Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years than in older patients. 

 

Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated 

with deferasirox. In post-marketing reports, a high proportion of cases of metabolic acidosis occurred 
in children in the context of Fanconi syndrome. 

 

Acute pancreatitis has been reported, particularly in children and adolescents. 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 
 

Early signs of acute overdose are digestive effects such as abdominal pain, diarrhoea, nausea and 

vomiting. Hepatic and renal disorders have been reported, including cases of liver enzyme and 

creatinine increased with recovery after treatment discontinuation. An erroneously administered single 

dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment. 

 

There is no specific antidote for deferasirox. Standard procedures for management of overdose may be 

indicated as well as symptomatic treatment, as medically appropriate. 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

37 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 

 
Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC03 

 

Mechanism of action 

Deferasirox is an orally active chelator that is highly selective for iron (III). It is a tridentate ligand that 

binds iron with high affinity in a 2:1 ratio. Deferasirox promotes excretion of iron, primarily in the 

faeces. Deferasirox has low affinity for zinc and copper, and does not cause constant low serum levels 

of these metals. 

 

Pharmacodynamic effects 

In an iron-balance metabolic study in iron-overloaded adult thalassaemic patients, deferasirox at daily 

doses of 10, 20 and 40 mg/kg (dispersible tablet formulation) induced the mean net excretion of 0.119, 

0.329 and 0.445 mg Fe/kg body weight/day, respectively. 

 

Clinical efficacy and safety 

Clinical efficacy studies were conducted with deferasirox dispersible tablets. 

 

Deferasirox has been investigated in 411 adult (age 16 years) and 292 paediatric patients (aged 2 to 

<16 years) with chronic iron overload due to blood transfusions. Of the paediatric patients 52 were 

aged 2 to 5 years. The underlying conditions requiring transfusion included beta-thalassaemia, sickle 

cell disease and other congenital and acquired anaemias (myelodysplastic syndromes [MDS], 

Diamond-Blackfan syndrome, aplastic anaemia and other very rare anaemias). 

 

Daily treatment with the deferasirox dispersible tablet formulation at doses of 20 and 30 mg/kg for one 

year in frequently transfused adult and paediatric patients with beta-thalassaemia led to reductions in 

indicators of total body iron; liver iron concentration was reduced by about -0.4 and -8.9 mg Fe/g liver 

(biopsy dry weight (dw)) on average, respectively, and serum ferritin was reduced by about -36 

and -926 µg/l on average, respectively. At these same doses the ratios of iron excretion: iron intake 

were 1.02 (indicating net iron balance) and 1.67 (indicating net iron removal), respectively. 

Deferasirox induced similar responses in iron-overloaded patients with other anaemias. Daily doses of 

10 mg/kg (dispersible tablet formulation) for one year could maintain liver iron and serum ferritin 

levels and induce net iron balance in patients receiving infrequent transfusions or exchange 

transfusions. Serum ferritin assessed by monthly monitoring reflected changes in liver iron 

concentration indicating that trends in serum ferritin can be used to monitor response to therapy. 

Limited clinical data (29 patients with normal cardiac function at baseline) using MRI indicate that 

treatment with deferasirox 10-30 mg/kg/day (dispersible tablet formulation) for 1 year may also 

reduce levels of iron in the heart (on average, MRI T2* increased from 18.3 to 23.0 milliseconds). 

 

The principal analysis of the pivotal comparative study in 586 patients suffering from 

beta-thalassaemia and transfusional iron overload did not demonstrate non-inferiority of deferasirox 

dispersible tablets to deferoxamine in the analysis of the total patient population. It appeared from a 

post-hoc analysis of this study that, in the subgroup of patients with liver iron concentration ≥7 mg 

Fe/g dw treated with deferasirox dispersible tablets (20 and 30 mg/kg) or deferoxamine (35 to 

≥50 mg/kg), the non-inferiority criteria were achieved. However, in patients with liver iron 

concentration <7 mg Fe/g dw treated with deferasirox dispersible tablets (5 and 10 mg/kg) or 

deferoxamine (20 to 35 mg/kg), non-inferiority was not established due to imbalance in the dosing of 

the two chelators. This imbalance occurred because patients on deferoxamine were allowed to remain 

on their pre-study dose even if it was higher than the protocol specified dose. Fifty-six patients under 

the age of 6 years participated in this pivotal study, 28 of them receiving deferasirox dispersible 

tablets. 

 



 

38 

It appeared from preclinical and clinical studies that deferasirox dispersible tablets could be as active 

as deferoxamine when used in a dose ratio of 2:1 (i.e. a dose of deferasirox dispersible tablets that is 

numerically half of the deferoxamine dose). For deferasirox film-coated tablets, a dose ratio of 3:1 can 

be considered (i.e. a dose of deferasirox film-coated tablets that is numerically one third of the 

deferoxamine dose). However, this dosing recommendation was not prospectively assessed in the 

clinical studies. 

 

In addition, in patients with liver iron concentration ≥7 mg Fe/g dw with various rare anaemias or 

sickle cell disease, deferasirox dispersible tablets up to 20 and 30 mg/kg produced a decrease in liver 

iron concentration and serum ferritin comparable to that obtained in patients with beta-thalassaemia. 

 

A placebo-controlled randomised study was performed in 225 patients with MDS (Low/Int-1 risk) and 

transfusional iron overload. The results of this study suggest that there is a positive impact of 

deferasirox on event-free survival (EFS, a composite endpoint including non-fatal cardiac or liver 

events) and serum ferritin levels. The safety profile was consistent with previous studies in adult MDS 

patients. 

 

In a 5-year observational study in which 267 children aged 2 to <6 years (at enrollment) with 

transfusional haemosiderosis received deferasirox, there were no clinically meaningful differences in 

the safety and tolerability profile of Exjade in paediatric patients aged 2 to <6 years compared to the 

overall adult and older paediatric population, including increases in serum creatinine of >33% and 

above the upper limit of normal on ≥2 consecutive occasions (3.1%), and elevation of alanine 

aminotransferase (ALT) greater than 5 times the upper limit of normal (4.3%). Single events of 

increase in ALT and aspartate aminotransferase were reported in 20.0% and 8.3%, respectively, of the 

145 patients who completed the study. 

 

In a study to assess the safety of deferasirox film-coated and dispersible tablets, 173 adult and 

paediatric patients with transfusion dependent thalassaemia or myelodysplastic syndrome were treated 

for 24 weeks. A comparable safety profile for film-coated and dispersible tablets was observed. 

 

In patients with non-transfusion-dependent thalassaemia syndromes and iron overload, treatment with 

deferasirox dispersible tablets was assessed in a 1-year, randomised, double-blind, placebo-controlled 

study. The study compared the efficacy of two different deferasirox dispersible tablet regimens 

(starting doses of 5 and 10 mg/kg/day, 55 patients in each arm) and of matching placebo (56 patients). 

The study enrolled 145 adult and 21 paediatric patients. The primary efficacy parameter was the 

change in liver iron concentration (LIC) from baseline after 12 months of treatment. One of the 

secondary efficacy parameters was the change in serum ferritin between baseline and fourth quarter. 

At a starting dose of 10 mg/kg/day, deferasirox dispersible tablets led to reductions in indicators of 

total body iron. On average, liver iron concentration decreased by 3.80 mg Fe/g dw in patients treated 

with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 0.38 mg Fe/g dw in 

patients treated with placebo (p<0.001). On average, serum ferritin decreased by 222.0 µg/l in patients 

treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 115 µg/l in 

patients treated with placebo (p<0.001). 

 

5.2 Pharmacokinetic properties 
 

EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible 

tablet formulation. After adjustment of the strength, the film-coated tablet formulation (360 mg 

strength) was equivalent to EXJADE dispersible tablets (500 mg strength) with respect to the mean 

area under the plasma concentration time curve (AUC) under fasting conditions. The Cmax was 

increased by 30% (90% CI: 20.3% - 40.0%); however a clinical exposure/response analysis revealed 

no evidence of clinically relevant effects of such an increase. 

 



 

39 

Absorption 

Deferasirox (dispersible tablet formulation) is absorbed following oral administration with a median 

time to maximum plasma concentration (tmax) of about 1.5 to 4 hours. The absolute bioavailability 

(AUC) of deferasirox (dispersible tablet formulation) is about 70% compared to an intravenous dose. 

The absolute bioavailability of the film-coated tablet formulation has not been determined. 

Bioavailability of deferasirox film-coated tablets was 36% greater than that with dispersible tablets. 

 

A food-effect study involving administration of the film-coated tablets to healthy volunteers under 

fasting conditions and with a low-fat (fat content <10% of calories) or high-fat (fat content >50% of 

calories) meal indicated that the AUC and Cmax were slightly decreased after a low-fat meal (by 11% 

and 16%, respectively). After a high-fat meal, AUC and Cmax were increased (by 18% and 29%, 

respectively). The increases in Cmax due to the change in formulation and due to the effect of a high-fat 

meal may be additive and therefore, it is recommended that the film-coated tablets should be taken 

either on an empty stomach or with a light meal. 

 

Distribution 

Deferasirox is highly (99%) protein bound to plasma proteins, almost exclusively serum albumin, and 

has a small volume of distribution of approximately 14 litres in adults. 

 

Biotransformation 

Glucuronidation is the main metabolic pathway for deferasirox, with subsequent biliary excretion. 

Deconjugation of glucuronidates in the intestine and subsequent reabsorption (enterohepatic recycling) 

is likely to occur: in a healthy volunteer study, the administration of cholestyramine after a single dose 

of deferasirox resulted in a 45% decrease in deferasirox exposure (AUC). 

 

Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3. CYP450-catalysed 

(oxidative) metabolism of deferasirox appears to be minor in humans (about 8%). No inhibition of 

deferasirox metabolism by hydroxyurea was observed in vitro. 

 

Elimination 

Deferasirox and its metabolites are primarily excreted in the faeces (84% of the dose). Renal excretion 

of deferasirox and its metabolites is minimal (8% of the dose). The mean elimination half-life (t1/2) 

ranged from 8 to 16 hours. The transporters MRP2 and MXR (BCRP) are involved in the biliary 

excretion of deferasirox. 

 

Linearity / non-linearity 

The Cmax and AUC0-24h of deferasirox increase approximately linearly with dose under steady-state 

conditions. Upon multiple dosing exposure increased by an accumulation factor of 1.3 to 2.3. 

 

Characteristics in patients 

Paediatric patients 

The overall exposure of adolescents (12 to ≤17 years) and children (2 to <12 years) to deferasirox after 

single and multiple doses was lower than that in adult patients. In children younger than 6 years old 

exposure was about 50% lower than in adults. Since dosing is individually adjusted according to 

response this is not expected to have clinical consequences. 

 

Gender 

Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males. 

Since dosing is individually adjusted according to response this is not expected to have clinical 

consequences. 

 

Elderly patients 

The pharmacokinetics of deferasirox have not been studied in elderly patients (aged 65 or older). 

 



 

40 

Renal or hepatic impairment 

The pharmacokinetics of deferasirox have not been studied in patients with renal impairment. The 

pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the 

upper limit of the normal range. 

 

In a clinical study using single doses of 20 mg/kg deferasirox dispersible tablets, the average exposure 

was increased by 16% in subjects with mild hepatic impairment (Child-Pugh Class A) and by 76% in 

subjects with moderate hepatic impairment (Child-Pugh Class B) compared to subjects with normal 

hepatic function. The average Cmax of deferasirox in subjects with mild or moderate hepatic 

impairment was increased by 22%. Exposure was increased 2.8-fold in one subject with severe hepatic 

impairment (Child-Pugh Class C) (see sections 4.2 and 4.4). 

 

5.3 Preclinical safety data 
 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential. The main findings were 

kidney toxicity and lens opacity (cataracts). Similar findings were observed in neonatal and juvenile 

animals. The kidney toxicity is considered mainly due to iron deprivation in animals that were not 

previously overloaded with iron. 

 

Tests of genotoxicity in vitro were negative (Ames test, chromosomal aberration test) while 

deferasirox caused formation of micronuclei in vivo in the bone marrow, but not liver, of 

non-iron-loaded rats at lethal doses. No such effects were observed in iron-preloaded rats. Deferasirox 

was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/- heterozygous 

mice in a 6-month study. 

 

The potential for toxicity to reproduction was assessed in rats and rabbits. Deferasirox was not 

teratogenic, but caused increased frequency of skeletal variations and stillborn pups in rats at high 

doses that were severely toxic to the non-iron-overloaded mother. Deferasirox did not cause other 

effects on fertility or reproduction. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Tablet core: 

Cellulose, microcrystalline 

Crospovidone 

Povidone 

Magnesium stearate 

Silica, colloidal anhydrous 

Poloxamer 

 

Coating material: 

Hypromellose 

Titanium dioxide (E171) 

Macrogol (4000) 

Talc 

Indigo carmine aluminium lake (E132) 

 

6.2 Incompatibilities 
 

Not applicable. 

 



 

41 

6.3 Shelf life 
 

3 years 

 

6.4 Special precautions for storage 
 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 
 

PVC/PVDC/Aluminium blisters. 

 

Unit packs containing 30 or 90 film-coated tablets or multipacks containing 300 (10 packs of 30) 

film-coated tablets. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal 
 

No special requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EXJADE 90 mg film-coated tablets 

EU/1/06/356/011 

EU/1/06/356/012 

EU/1/06/356/013 

 

EXJADE 180 mg film-coated tablets 

EU/1/06/356/014 

EU/1/06/356/015 

EU/1/06/356/016 

 

EXJADE 360 mg film-coated tablets 

EU/1/06/356/017 

EU/1/06/356/018 

EU/1/06/356/019 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 28 August 2006 

Date of latest renewal: 18 April 2016 

 

 



 

42 

10. DATE OF REVISION OF THE TEXT 
 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu 

http://www.ema.europa.eu/


 

43 

This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

 

1. NAME OF THE MEDICINAL PRODUCT 
 

EXJADE 90 mg granules in sachet 

EXJADE 180 mg granules in sachet 

EXJADE 360 mg granules in sachet 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

EXJADE 90 mg granules 

Each sachet contains 90 mg deferasirox. 

 

EXJADE 180 mg granules 

Each sachet contains 180 mg deferasirox. 

 

EXJADE 360 mg granules 

Each sachet contains 360 mg deferasirox. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Granules in sachet (granules) 

 

White to almost white granules 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

EXJADE is indicated 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. 

 

EXJADE is also indicated for the treatment of chronic iron overload due to blood transfusions when 

deferoxamine therapy is contraindicated or inadequate in the following patient groups: 

- in paediatric patients with beta thalassaemia major with iron overload due to frequent blood 

transfusions (7 ml/kg/month of packed red blood cells) aged 2 to 5 years, 

- in adult and paediatric patients with beta thalassaemia major with iron overload due to 

infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and 

older, 

- in adult and paediatric patients with other anaemias aged 2 years and older. 
 

EXJADE is also indicated for the treatment of chronic iron overload requiring chelation therapy when 

deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent 

thalassaemia syndromes aged 10 years and older. 

 



 

44 

4.2 Posology and method of administration 
 

Treatment with EXJADE should be initiated and maintained by physicians experienced in the 

treatment of chronic iron overload. 

 

Posology 

 

Transfusional iron overload 

 

It is recommended that treatment be started after the transfusion of approximately 20 units (about 

100 ml/kg) of packed red blood cells (PRBC) or when there is evidence from clinical monitoring that 

chronic iron overload is present (e.g. serum ferritin >1,000 µg/l). Doses (in mg/kg) must be calculated 

and rounded to the nearest whole sachet size. 

 

The goals of iron chelation therapy are to remove the amount of iron administered in transfusions and, 

as required, to reduce the existing iron burden. 

 

Caution should be taken during chelation therapy to minimise the risk of overchelation in all patients 

(see section 4.4). 

 

EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet 

formulation (see section 5.2). In case of switching from dispersible tablets to granules, the dose of the 

granules should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole 

sachet. 

 

The corresponding doses for the different formulations are shown in the table below. 

 



 

45 

Table 1 Recommended doses for transfusional iron overload 

 

 Film-coated 

tablets/granules 

Dispersible tablets Transfusions  Serum 

ferritin 

Starting dose 14 mg/kg/day 20 mg/kg/day After 20 units 

(about 100 ml/kg) 

of PRBC 

or >1,000 µg/l 

Alternative 

starting doses 

21 mg/kg/day 30 mg/kg/day >14 ml/kg/month 

of PRBC (approx. 

>4 units/month 

for an adult) 

  

 7 mg/kg/day 10 mg/kg/day <7 ml/kg/month 

of PRBC (approx. 

<2 units/month 

for an adult) 

  

For patients 

well managed 

on 

deferoxamine 

One third of 

deferoxamine dose 

Half of 

deferoxamine dose 

   

Monitoring     Monthly 

Target range     500-1,000 µg/l 

      

Adjustment 

steps 
(every 

3-6 months) 

Increase   >2,500 µg/l 

3.5 - 7 mg/kg/day 

Up to 28 mg/kg/day 

5-10 mg/kg/day 

Up to 40 mg/kg/day 

   

Decrease    

3.5 - 7 mg/kg/day 5-10 mg/kg/day   <2,500 µg/l 

In patients treated 

with doses 

>21 mg/kg/day 

In patients treated 

with doses 

>30 mg/kg/day 

   

- When target is reached   500-1,000 µg/l 

Maximum 

dose 

28 mg/kg/day 40 mg/kg/day    

Consider 

interruption 

    <500 µg/l 

 

  



 

46 

Starting dose 

The recommended initial daily dose of EXJADE granules is 14 mg/kg body weight. 

 

An initial daily dose of 21 mg/kg may be considered for patients who require reduction of elevated 

body iron levels and who are also receiving more than 14 ml/kg/month of packed red blood cells 

(approximately >4 units/month for an adult). 

 

An initial daily dose of 7 mg/kg may be considered for patients who do not require reduction of body 

iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells 

(approximately <2 units/month for an adult). The patient’s response must be monitored and a dose 

increase should be considered if sufficient efficacy is not obtained (see section 5.1). 

 

For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE 

granules that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient 

receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a 

starting daily dose of 14 mg/kg/day of EXJADE granules). When this results in a daily dose less than 

14 mg/kg body weight, the patient’s response must be monitored and a dose increase should be 

considered if sufficient efficacy is not obtained (see section 5.1). 

 

Dose adjustment 

It is recommended that serum ferritin be monitored every month and that the dose of EXJADE be 

adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin. Dose adjustments 

may be made in steps of 3.5 to 7 mg/kg and are to be tailored to the individual patient’s response and 

therapeutic goals (maintenance or reduction of iron burden). In patients not adequately controlled with 

doses of 21 mg/kg (e.g. serum ferritin levels persistently above 2,500 µg/l and not showing a 

decreasing trend over time), doses of up to 28 mg/kg may be considered. The availability of long-term 

efficacy and safety data from clinical studies conducted with EXJADE dispersible tablets used at 

doses above 30 mg/kg is currently limited (264 patients followed for an average of 1 year after dose 

escalation). If only very poor haemosiderosis control is achieved at doses up to 21 mg/kg, a further 

increase (to a maximum of 28 mg/kg) may not achieve satisfactory control, and alternative treatment 

options may be considered. If no satisfactory control is achieved at doses above 21 mg/kg, treatment at 

such doses should not be maintained and alternative treatment options should be considered whenever 

possible. Doses above 28 mg/kg are not recommended because there is only limited experience with 

doses above this level (see section 5.1). 

 

In patients treated with doses greater than 21 mg/kg, dose reductions in steps of 3.5 to 7 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 1,000 µg/l), dose reductions in steps of 3.5 to 7 mg/kg should be 

considered to maintain serum ferritin levels within the target range and to minimise the risk of 

overchelation. If serum ferritin falls consistently below 500 µg/l, an interruption of treatment should 

be considered (see section 4.4). 

 

Non-transfusion-dependent thalassaemia syndromes 

 

Chelation therapy should only be initiated when there is evidence of iron overload (liver iron 

concentration [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin consistently >800 µg/l). LIC is the 

preferred method of iron overload determination and should be used wherever available. Caution 

should be taken during chelation therapy to minimise the risk of overchelation in all patients (see 

section 4.4). 

 

EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet 

formulation (see section 5.2). In case of switching from dispersible tablets to granules, the dose of the 

granules should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole 

sachet. 

 

The corresponding doses for the different formulations are shown in the table below. 



 

47 

 

Table 2 Recommended doses for non-transfusion-dependent thalassaemia syndromes 

 

 Film-coated 

tablets/granules 

Dispersible 

tablets 

Liver iron 

concentration 

(LIC)* 

 Serum 

ferritin 

Starting dose 7 mg/kg/day 10 mg/kg/day ≥5 mg Fe/g dw or >800 µg/l 

Monitoring     Monthly 

Adjustment 

steps 
(every 

3-6 months) 

Increase ≥7 mg Fe/g dw or >2,000 µg/l 

3.5 - 7 mg/kg/day 5-10 mg/kg/day    

Decrease <7 mg Fe/g dw or ≤2,000 µg/l 

3.5 - 7 mg/kg/day 5-10 mg/kg/day    

Maximum 

dose 

14 mg/kg/day 20 mg/kg/day    

 7 mg/kg/day 10 mg/kg/day    

 For adults not assessed and ≤2,000 µg/l 
 For paediatric patients    

Interruption   <3 mg Fe/g dw or <300 µg/l 

Retreatment   Not recommended 

*LIC is the preferred method of iron overload determination. 

 

Starting dose 

The recommended initial daily dose of EXJADE granules in patients with non-transfusion-dependent 

thalassaemia syndromes is 7 mg/kg body weight. 

 

Dose adjustment 

It is recommended that serum ferritin be monitored every month to assess the patient’s response to 

therapy and to minimise the risk of overchelation (see section 4.4). After every 3 to 6 months of 

treatment, a dose increase in increments of 3.5 to 7 mg/kg should be considered if the patient’s LIC is 

≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and 

the patient is tolerating the medicinal product well. Doses above 14 mg/kg are not recommended 

because there is no experience with doses above this level in patients with non-transfusion-dependent 

thalassaemia syndromes. 

 

In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 

7 mg/kg. 

 

For patients in whom the dose was increased to >7 mg/kg, dose reduction to 7 mg/kg or less is 

recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l. 

 

Treatment cessation 

Once a satisfactory body iron level has been achieved (LIC <3 mg Fe/g dw or serum ferritin 

<300 µg/l), treatment should be stopped. There are no data available on the retreatment of patients 

who reaccumulate iron after having achieved a satisfactory body iron level and therefore retreatment 

cannot be recommended. 

 

Special populations 

 

Elderly patients (≥65 years of age) 

The dosing recommendations for elderly patients are the same as described above. In clinical studies, 

elderly patients experienced a higher frequency of adverse reactions than younger patients (in 

particular, diarrhoea) and should be monitored closely for adverse reactions that may require a dose 

adjustment. 

 



 

48 

Paediatric population 

Transfusional iron overload: 

The dosing recommendations for paediatric patients aged 2 to 17 years with transfusional iron 

overload are the same as for adult patients (see section 4.2). It is recommended that serum ferritin be 

monitored every month to assess the patient’s response to therapy and to minimise the risk of 

overchelation (see section 4.4). Changes in weight of paediatric patients over time must be taken into 

account when calculating the dose. 

 

In children with transfusional iron overload 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. 

 

Non-transfusion-dependent thalassaemia syndromes: 

In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not 

exceed 7 mg/kg. In these patients, closer monitoring of LIC and serum ferritin is essential to avoid 

overchelation (see section 4.4). In addition to monthly serum ferritin assessments, LIC should be 

monitored every three months when serum ferritin is ≤800 µg/l. 

 

Children from birth to 23 months: 

The safety and efficacy of EXJADE in children from birth to 23 months of age have not 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 is not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In 

patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be considerably 

reduced followed by progressive increase up to a limit of 50% (see sections 4.4 and 5.2), and EXJADE 

must be used with caution in such patients. 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. 

 

The granules should be administered by sprinkling the full dose onto soft food, e.g. yogurt or apple 

sauce (pureed apple). The dose should be immediately and completely consumed, and not stored for 

future use. 
 

The soft food containing the granules should be taken with or without a light meal, once a day, 
preferably at the same time each day (see sections 4.5 and 5.2). 

 

4.3 Contraindications 
 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

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. 

 

  



 

49 

4.4 Special warnings and precautions for use 
 

Renal function 

 

Deferasirox has been studied only in patients with baseline serum creatinine within the 

age-appropriate normal range. 

 
During clinical studies, 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. In some cases, only a stabilisation of the 

serum creatinine values has been observed after dose reduction. Cases of acute renal failure have been 

reported following post-marketing use of deferasirox (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 

deferasirox and/or low rates of transfusion (<7 ml/kg/month of packed red blood cells or 

<2 units/month for an adult). While no increase in renal adverse events was observed after dose 

escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk 

of renal adverse events with granule doses above 21 mg/kg cannot be excluded. 

 

It is recommended that serum creatinine be assessed in duplicate before initiating therapy. Serum 

creatinine, creatinine clearance (estimated with the Cockcroft-Gault or MDRD formula in adults and 

with the Schwartz formula in children) and/or plasma cystatin C levels should be monitored prior to 

therapy, weekly in the first month after initiation or modification of therapy with EXJADE 

(including switch of formulation), and monthly thereafter. Patients with pre-existing renal 

conditions and patients who are receiving medicinal products that depress renal function may be more 

at risk of complications. Care should be taken to maintain adequate hydration in patients who develop 

diarrhoea or vomiting. 

 

There have been post-marketing reports of metabolic acidosis occurring during treatment with 

deferasirox. The majority of these patients had renal impairment, renal tubulopathy (Fanconi 

syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication. Acid-base 

balance should be monitored as clinically indicated in these populations. Interruption of EXJADE 

therapy should be considered in patients who develop metabolic acidosis. 

 

Post-marketing cases of severe forms of renal tubulopathy (such as Fanconi syndrome) and renal 

failure associated with changes in consciousness in the context of hyperammonaemic encephalopathy 

have been reported in patients treated with deferasirox, mainly in children. It is recommended that 

hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who 

develop unexplained changes in mental status while on Exjade therapy. 

 



 

50 

Table 3 Dose adjustment and interruption of treatment for renal monitoring 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Treatment may be reinitiated depending on the individual clinical circumstances. 

 

Dose reduction or interruption may be also considered if abnormalities occur in levels of markers of 

renal tubular function and/or as clinically indicated: 

• Proteinuria (test should be performed prior to therapy and monthly thereafter) 

• Glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, 

phosphaturia, aminoaciduria (monitor as needed). 

Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated 

with EXJADE. 

 

Patients should be referred to a renal specialist, and further specialised investigations (such as renal 

biopsy) may be considered if the following occur despite dose reduction and interruption: 

• Serum creatinine remains significantly elevated and 

• Persistent abnormality in another marker of renal function (e.g. proteinuria, Fanconi Syndrome). 

 

Hepatic function 
 

Liver function test elevations have been observed in patients treated with deferasirox. Post-marketing 

cases of hepatic failure, some of which were fatal, have been reported. Severe forms associated with 

changes in consciousness in the context of hyperammonaemic encephalopathy, may occur in patients 

treated with deferasirox, particularly in children. It is recommended that hyperammonaemic 

encephalopathy be considered and ammonia levels measured in patients who develop unexplained 

changes in mental status while on Exjade therapy. Care should be taken to maintain adequate 

hydration in patients who experience volume-depleting events (such as diarrhoea or vomiting), 

particularly in children with acute illness. Most reports of hepatic failure involved patients with 

significant comorbidities including pre-existing chronic liver conditions (including cirrhosis and 

hepatitis C) and multi-organ failure. The role of deferasirox as a contributing or aggravating factor 
cannot be excluded (see section 4.8). 

 

 Serum creatinine  Creatinine clearance 

Before initiation of 

therapy 

Twice (2x) and Once (1x) 

Contraindicated   <60 ml/min 

Monitoring    

- First month after 

start of therapy or 

dose modification 

(including switch 

of formulation) 

Weekly and Weekly 

- Thereafter Monthly and Monthly 

Reduction of daily dose by 7 mg/kg/day (film-coated tablet formulation), 

if following renal parameters are observed at two consecutive visits and cannot be attributed to 

other causes 

Adult patients >33% above pre-

treatment average 

and Decreases <LLN* 

(<90 ml/min) 

Paediatric patients > age appropriate 

ULN**  

and/or Decreases <LLN* 

(<90 ml/min) 

After dose reduction, interrupt treatment, if 

Adult and paediatric Remains >33% above 

pre-treatment average 

and/or Decreases <LLN* 

(<90 ml/min) 

*LLN: lower limit of the normal range 

**ULN: upper limit of the normal range 

 



 

51 

It is recommended that serum transaminases, bilirubin and alkaline phosphatase be checked before the 

initiation of treatment, every 2 weeks during the first month and monthly thereafter. If there is a 

persistent and progressive increase in serum transaminase levels that cannot be attributed to other 

causes, EXJADE should be interrupted. Once the cause of the liver function test abnormalities has 

been clarified or after return to normal levels, cautious re-initiation of treatment at a lower dose 

followed by gradual dose escalation may be considered. 

 

EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see 

section 5.2). 

 

Table 4 Summary of safety monitoring recommendations 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

In patients with a short life expectancy (e.g. high-risk myelodysplastic syndromes), especially when 

co-morbidities could increase the risk of adverse events, the benefit of EXJADE might be limited and 

may be inferior to risks. As a consequence, treatment with EXJADE is not recommended in these 

patients. 

 

Caution should be used in elderly patients due to a higher frequency of adverse reactions (in particular, 

diarrhoea). 

 

Data in children with non-transfusion-dependent thalassaemia are very limited (see section 5.1). As a 

consequence, EXJADE therapy should be closely monitored to detect adverse reactions and to follow 

iron burden in the paediatric population. In addition, before treating heavily iron-overloaded children 

with non-transfusion-dependent thalassaemia with EXJADE, the physician should be aware that the 

consequences of long-term exposure in such patients are currently not known. 

 

Test Frequency 

Serum creatinine In duplicate prior to therapy. 

Weekly during first month of therapy or 

after dose modification (including switch 

of formulation). 

Monthly thereafter. 

Creatinine clearance and/or plasma 

cystatin C 

Prior to therapy. 

Weekly during first month of therapy or 

after dose modification (including switch 

of formulation). 

Monthly thereafter. 

Proteinuria Prior to therapy. 

Monthly thereafter. 

Other markers of renal tubular function 

(such as glycosuria in non-diabetics and 

low levels of serum potassium, 

phosphate, magnesium or urate, 

phosphaturia, aminoaciduria) 

As needed. 

Serum transaminases, bilirubin, alkaline 

phosphatase 

Prior to therapy. 

Every 2 weeks during first month of 

therapy. 

Monthly thereafter. 

Auditory and ophthalmic testing Prior to therapy. 

Annually thereafter. 

Body weight, height and sexual 

development 

Prior to therapy. 

Annually in paediatric patients. 

 



 

52 

Gastrointestinal disorders 

Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children 

and adolescents, receiving deferasirox. Multiple ulcers have been observed in some patients (see 

section 4.8). There have been reports of ulcers complicated with digestive perforation. Also, there 

have been reports of fatal gastrointestinal haemorrhages, especially in elderly patients who had 

haematological malignancies and/or low platelet counts. Physicians and patients should remain alert 

for signs and symptoms of gastrointestinal ulceration and haemorrhage during EXJADE therapy. In 

case of gastrointestinal ulceration or haemorrhage, EXJADE should be discontinued and additional 

evaluation and treatment must be promptly initiated. Caution should be exercised in patients who are 

taking EXJADE in combination with substances that have known ulcerogenic potential, such as 

NSAIDs, corticosteroids, or oral bisphosphonates, in patients receiving anticoagulants and in patients 

with platelet counts below 50,000/mm3 (50 x 109/l) (see section 4.5). 

 

Skin disorders 

Skin rashes may appear during EXJADE treatment. The rashes resolve spontaneously in most cases. 

When interruption of treatment may be necessary, treatment may be reintroduced after resolution of 

the rash, at a lower dose followed by gradual dose escalation. In severe cases this reintroduction could 

be conducted in combination with a short period of oral steroid administration. Severe cutaneous 

adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis 

(TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be 

life-threatening or fatal, have been reported. If any SCAR is suspected, EXJADE should be 

discontinued immediately and should not be reintroduced. At the time of prescription, patients should 

be advised of the signs and symptoms of severe skin reactions, and be closely monitored. 

 

Hypersensitivity reactions 

Cases of serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported 

in patients receiving deferasirox, with the onset of the reaction occurring in the majority of cases 

within the first month of treatment (see section 4.8). If such reactions occur, EXJADE should be 

discontinued and appropriate medical intervention instituted. Deferasirox should not be reintroduced 

in patients who have experienced a hypersensitivity reaction due to the risk of anaphylactic shock (see 

section 4.3). 

 

Vision and hearing 

Auditory (decreased hearing) and ocular (lens opacities) disturbances have been reported (see section 

4.8). Auditory and ophthalmic testing (including fundoscopy) is recommended before the start of 

treatment and at regular intervals thereafter (every 12 months). If disturbances are noted during the 

treatment, dose reduction or interruption may be considered. 

 

Blood disorders 

There have been post-marketing reports of leukopenia, thrombocytopenia or pancytopenia (or 

aggravation of these cytopenias) and of aggravated anaemia in patients treated with deferasirox. Most 

of these patients had pre-existing haematological disorders that are frequently associated with bone 

marrow failure. However, a contributory or aggravating role cannot be excluded. Interruption of 

treatment should be considered in patients who develop unexplained cytopenia. 

 

Other considerations 

Monthly monitoring of serum ferritin is recommended in order to assess the patient’s response to 

therapy and to avoid overchelation (see section 4.2). Dose reduction or closer monitoring of renal and 

hepatic function, and serum ferritin levels are recommended during periods of treatments with high 

doses and when serum ferritin levels are close to the target range. If serum ferritin falls consistently 

below 500 µg/l (in transfusional iron overload) or below 300 µg/l (in non-transfusion-dependent 

thalassaemia syndromes), an interruption of treatment should be considered. 

 

The results of the tests for serum creatinine, serum ferritin and serum transaminases should be 

recorded and regularly assessed for trends. 

 



 

53 

In two clinical studies, growth and sexual development of paediatric patients treated with deferasirox 

for up to 5 years were not affected (see section 4.8). However, as a general precautionary measure in 

the management of paediatric patients with transfusional iron overload, body weight, height and 

sexual development should be monitored prior to therapy and at regular intervals (every 12 months). 

 

Cardiac dysfunction is a known complication of severe iron overload. Cardiac function should be 

monitored in patients with severe iron overload during long-term treatment with EXJADE. 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

The safety of deferasirox in combination with other iron chelators has not been established. Therefore, 

it must not be combined with other iron chelator therapies (see section 4.3). 

 

Interaction with food 

There were no clinically relevant changes in deferasirox pharmacokinetics when EXJADE granules 

were administered with food. Although there was no significant effect (increase in the extent of 

absorption AUC by 18-19%; no change in Cmax) of a high-fat meal on deferasirox pharmacokinetics, it 

is recommended that deferasirox granules be taken either with or without a light meal (see section 

5.2). 

 

Agents that may decrease EXJADE systemic exposure 

Deferasirox metabolism depends on UGT enzymes. In a healthy volunteer study, the concomitant 

administration of deferasirox (single dose of 30 mg/kg, dispersible tablet formulation) and the potent 

UGT inducer, rifampicin, (repeated dose of 600 mg/day) resulted in a decrease of deferasirox exposure 

by 44% (90% CI: 37% - 51%). Therefore, the concomitant use of EXJADE with potent UGT inducers 

(e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may result in a decrease in 

EXJADE efficacy. The patient’s serum ferritin should be monitored during and after the combination, 

and the dose of EXJADE adjusted if necessary. 

 

Cholestyramine significantly reduced the deferasirox exposure in a mechanistic study to determine the 

degree of enterohepatic recycling (see section 5.2). 

 

Interaction with midazolam and other agents metabolised by CYP3A4 

In a healthy volunteer study, the concomitant administration of deferasirox dispersible tablets and 

midazolam (a CYP3A4 probe substrate) resulted in a decrease of midazolam exposure by 17% (90% 

CI: 8% - 26%). In the clinical setting, this effect may be more pronounced. Therefore, due to a 

possible decrease in efficacy, caution should be exercised when deferasirox is combined with 

substances metabolised through CYP3A4 (e.g. ciclosporin, simvastatin, hormonal contraceptive 

agents, bepridil, ergotamine). 

 

Interaction with repaglinide and other agents metabolised by CYP2C8 

In a healthy volunteer study, the concomitant administration of deferasirox as a moderate CYP2C8 

inhibitor (30 mg/kg daily, dispersible tablet formulation), with repaglinide, a CYP2C8 substrate, given 

as a single dose of 0.5 mg, increased repaglinide AUC and Cmax about 2.3-fold (90% CI [2.03-2.63]) 

and 1.6-fold (90% CI [1.42-1.84]), respectively. Since the interaction has not been established with 

dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should 

be avoided. If the combination appears necessary, careful clinical and blood glucose monitoring 

should be performed (see section 4.4). An interaction between deferasirox and other CYP2C8 

substrates like paclitaxel cannot be excluded. 

 



 

54 

Interaction with theophylline and other agents metabolised by CYP1A2 

In a healthy volunteer study, the concomitant administration of deferasirox as a CYP1A2 inhibitor 

(repeated dose of 30 mg/kg/day, dispersible tablet formulation) and the CYP1A2 substrate 

theophylline (single dose of 120 mg) resulted in an increase of theophylline AUC by 84% (90% CI: 

73% to 95%). The single dose Cmax was not affected, but an increase of theophylline Cmax is expected 

to occur with chronic dosing. Therefore, the concomitant use of deferasirox with theophylline is not 

recommended. If deferasirox and theophylline are used concomitantly, monitoring of theophylline 

concentration and theophylline dose reduction should be considered. An interaction between 

deferasirox and other CYP1A2 substrates cannot be excluded. For substances that are predominantly 

metabolised by CYP1A2 and that have a narrow therapeutic index (e.g. clozapine, tizanidine), the 

same recommendations apply as for theophylline. 

 

Other information 

The concomitant administration of deferasirox and aluminium-containing antacid preparations has not 

been formally studied. Although deferasirox has a lower affinity for aluminium than for iron, it is not 

recommended to take deferasirox granules with aluminium-containing antacid preparations. 

 

The concomitant administration of deferasirox with substances that have known ulcerogenic potential, 

such as NSAIDs (including acetylsalicylic acid at high dosage), corticosteroids or oral 

bisphosphonates may increase the risk of gastrointestinal toxicity (see section 4.4). The concomitant 

administration of deferasirox with anticoagulants may also increase the risk of gastrointestinal 

haemorrhage. Close clinical monitoring is required when deferasirox is combined with these 

substances. 

 

Concomitant administration of deferasirox and busulfan resulted in an increase of busulfan exposure 

(AUC), but the mechanism of the interaction remains unclear. If possible, evaluation of the 

pharmacokinetics (AUC, clearance) of a busulfan test dose should be performed to allow dose 

adjustment. 

 

4.6 Fertility, pregnancy and lactation 
 

Pregnancy 

No clinical data on exposed pregnancies are available for deferasirox. Studies in animals have shown 

some reproductive toxicity at maternally toxic doses (see section 5.3). The potential risk for humans is 

unknown. 

 

As a precaution, it is recommended that EXJADE is not used during pregnancy unless clearly 

necessary. 

 

EXJADE may decrease the efficacy of hormonal contraceptives (see section 4.5). Women of 

childbearing potential are recommended to use additional or alternative non-hormonal methods of 

contraception when using EXJADE. 

 

Breast-feeding 

In animal studies, deferasirox was found to be rapidly and extensively secreted into maternal milk. No 

effect on the offspring was noted. It is not known if deferasirox is secreted into human milk. 

Breast-feeding while taking EXJADE is not recommended. 

 

Fertility 

No fertility data is available for humans. In animals, no adverse effects on male or female fertility 

were found (see section 5.3). 

 

  



 

55 

4.7 Effects on ability to drive and use machines 
 

EXJADE has minor influence on the ability to drive and use machines. Patients experiencing the 

uncommon adverse reaction of dizziness should exercise caution when driving or operating machines 

(see section 4.8). 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

The most frequent reactions reported during chronic treatment in clinical studies conducted with 

deferasirox dispersible tablets 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. These reactions are 

dose-dependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is 

continued. 

 

During clinical studies dose-dependent increases in serum creatinine occurred in about 36% of 

patients, though most remained within the normal range. Decreases in mean creatinine clearance have 

been observed in both paediatric and adult patients with beta-thalassemia and iron overload during the 

first year of treatment, but there is evidence that this does not decrease further in subsequent years of 

treatment. Elevations of liver transaminases have been reported. Safety monitoring schedules for renal 

and liver parameters are recommended. Auditory (decreased hearing) and ocular (lens opacities) 

disturbances are uncommon, and yearly examinations are also recommended (see section 4.4). 

 

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic 

epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) 

have been reported with the use of EXJADE (see section 4.4). 

 

Tabulated list of adverse reactions 

Adverse reactions are ranked below using the following convention: very common (≥1/10); common 

(≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 

(<1/10,000); not known (cannot be estimated from the available data). Within each frequency 

grouping, adverse reactions are presented in order of decreasing seriousness. 
 

  



 

56 

Table 5 

 

Blood and lymphatic system disorders 

 Not known: Pancytopenia1, thrombocytopenia1, anaemia aggravated1, 
neutropenia1 

Immune system disorders 

 Not known: Hypersensitivity reactions (including anaphylactic reactions and 

angioedema)1 

Metabolism and nutrition disorders 

 Not known: Metabolic acidosis1 

Psychiatric disorders 

 Uncommon: Anxiety, sleep disorder 

Nervous system disorders 

 Common: Headache 

 Uncommon: Dizziness 

Eye disorders 

 Uncommon: Cataract, maculopathy 

 Rare: Optic neuritis 

Ear and labyrinth disorders 

 Uncommon: Deafness 

Respiratory, thoracic and mediastinal disorders 

 Uncommon: Laryngeal pain 

Gastrointestinal disorders 

 Common: Diarrhoea, constipation, vomiting, nausea, abdominal pain, 

abdominal distension, dyspepsia 

 Uncommon: Gastrointestinal haemorrhage, gastric ulcer (including multiple 

ulcers), duodenal ulcer, gastritis 

 Rare: Oesophagitis 

 Not known: Gastrointestinal perforation1, acute pancreatitis1 

Hepatobiliary disorders 

 Common: Transaminases increased 

 Uncommon: Hepatitis, cholelithiasis 

 Not known: Hepatic failure1, 2 

Skin and subcutaneous tissue disorders 

 Common: Rash, pruritus 

 Uncommon: Pigmentation disorder 

 Rare: Drug reaction with eosinophilia and systemic symptoms (DRESS) 

 Not known: Stevens-Johnson syndrome1, hypersensitivity vasculitis1, urticaria1, 

erythema multiforme1, alopecia1, toxic epidermal necrolysis (TEN)1 

Renal and urinary disorders 

 Very common: Blood creatinine increased 

 Common: Proteinuria 

 Uncommon: Renal tubular disorder2 (acquired Fanconi syndrome), glycosuria 

 Not known: Acute renal failure1, 2, tubulointerstitial nephritis1, nephrolithiasis1, 

renal tubular necrosis1 

General disorders and administration site conditions 

 Uncommon: Pyrexia, oedema, fatigue 
1 Adverse reactions reported during post-marketing experience. These are derived from 

spontaneous reports for which it is not always possible to reliably establish frequency or a 

causal relationship to exposure to the medicinal product. 
2 Severe forms associated with changes in consciousness in the context of hyperammonaemic 

encephalopathy have been reported. 

 



 

57 

Description of selected adverse reactions 

Gallstones and related biliary disorders were reported in about 2% of patients. Elevations of liver 

transaminases were reported as an adverse reaction in 2% of patients. Elevations of transaminases 

greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon 

(0.3%). During post-marketing experience, hepatic failure, sometimes fatal, has been reported with 

deferasirox (see section 4.4). There have been post-marketing reports of metabolic acidosis. The 

majority of these patients had renal impairment, renal tubulopathy (Fanconi syndrome) or diarrhoea, 

or conditions where acid-base imbalance is a known complication (see section 4.4). Cases of serious 

acute pancreatitis were observed without documented underlying biliary conditions. As with other iron 

chelator treatment, high-frequency hearing loss and lenticular opacities (early cataracts) have been 

uncommonly observed in patients treated with deferasirox (see section 4.4). 

 

Creatinine clearance in transfusional iron overload 

In a retrospective meta-analysis of 2,102 adult and paediatric beta-thalassaemia patients with 

transfusional iron overload treated with deferasirox dispersible tablets in two randomised and four 

open label studies of up to five years’ duration, a mean creatinine clearance decrease of 13.2% in adult 

patients (95% CI: -14.4% to -12.1%; n=935) and 9.9% (95% CI: -11.1% to -8.6%; n=1,142) in 

paediatric patients was observed during the first year of treatment. In 250 patients who were followed 

for up to five years, no further decrease in mean creatinine clearance levels was observed. 

 

Clinical study in patients with non-transfusion-dependent thalassaemia syndromes 

In a 1-year study in patients with non-transfusion-dependent thalassaemia syndromes and iron 

overload (dispersible tablets at a dose of 10 mg/kg/day), diarrhoea (9.1%), rash (9.1%), and nausea 

(7.3%) were the most frequent study drug-related adverse events. Abnormal serum creatinine and 

creatinine clearance values were reported in 5.5% and 1.8% of patients, respectively. Elevations of 

liver transaminases greater than 2 times the baseline and 5 times the upper limit of normal were 

reported in 1.8% of patients. 

 

Paediatric population 

In two clinical studies, growth and sexual development of paediatric patients treated with deferasirox 

for up to 5 years were not affected (see section 4.4). 

 
Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years than in older patients. 

 

Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated 

with deferasirox. In post-marketing reports, a high proportion of cases of metabolic acidosis occurred 
in children in the context of Fanconi syndrome. 

 

Acute pancreatitis has been reported, particularly in children and adolescents. 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 
 

Early signs of acute overdose are digestive effects such as abdominal pain, diarrhoea, nausea and 

vomiting. Hepatic and renal disorders have been reported, including cases of liver enzyme and 

creatinine increased with recovery after treatment discontinuation. An erroneously administered single 

dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment. 

 

There is no specific antidote for deferasirox. Standard procedures for management of overdose may be 

indicated as well as symptomatic treatment, as medically appropriate. 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

58 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 

 
Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC03 

 

Mechanism of action 

Deferasirox is an orally active chelator that is highly selective for iron (III). It is a tridentate ligand that 

binds iron with high affinity in a 2:1 ratio. Deferasirox promotes excretion of iron, primarily in the 

faeces. Deferasirox has low affinity for zinc and copper, and does not cause constant low serum levels 

of these metals. 

 

Pharmacodynamic effects 

In an iron-balance metabolic study in iron-overloaded adult thalassaemic patients, deferasirox at daily 

doses of 10, 20 and 40 mg/kg (dispersible tablet formulation) induced the mean net excretion of 0.119, 

0.329 and 0.445 mg Fe/kg body weight/day, respectively. 

 

Clinical efficacy and safety 

Clinical efficacy studies were conducted with deferasirox dispersible tablets. 

 

Deferasirox has been investigated in 411 adult (age 16 years) and 292 paediatric patients (aged 2 to 

<16 years) with chronic iron overload due to blood transfusions. Of the paediatric patients 52 were 

aged 2 to 5 years. The underlying conditions requiring transfusion included beta-thalassaemia, sickle 

cell disease and other congenital and acquired anaemias (myelodysplastic syndromes [MDS], 

Diamond-Blackfan syndrome, aplastic anaemia and other very rare anaemias). 

 

Daily treatment with the deferasirox dispersible tablet formulation at doses of 20 and 30 mg/kg for one 

year in frequently transfused adult and paediatric patients with beta-thalassaemia led to reductions in 

indicators of total body iron; liver iron concentration was reduced by about -0.4 and -8.9 mg Fe/g liver 

(biopsy dry weight (dw)) on average, respectively, and serum ferritin was reduced by about -36 

and -926 µg/l on average, respectively. At these same doses the ratios of iron excretion: iron intake 

were 1.02 (indicating net iron balance) and 1.67 (indicating net iron removal), respectively. 

Deferasirox induced similar responses in iron-overloaded patients with other anaemias. Daily doses of 

10 mg/kg (dispersible tablet formulation) for one year could maintain liver iron and serum ferritin 

levels and induce net iron balance in patients receiving infrequent transfusions or exchange 

transfusions. Serum ferritin assessed by monthly monitoring reflected changes in liver iron 

concentration indicating that trends in serum ferritin can be used to monitor response to therapy. 

Limited clinical data (29 patients with normal cardiac function at baseline) using MRI indicate that 

treatment with deferasirox 10-30 mg/kg/day (dispersible tablet formulation) for 1 year may also 

reduce levels of iron in the heart (on average, MRI T2* increased from 18.3 to 23.0 milliseconds). 

 

The principal analysis of the pivotal comparative study in 586 patients suffering from 

beta-thalassaemia and transfusional iron overload did not demonstrate non-inferiority of deferasirox 

dispersible tablets to deferoxamine in the analysis of the total patient population. It appeared from a 

post-hoc analysis of this study that, in the subgroup of patients with liver iron concentration ≥7 mg 

Fe/g dw treated with deferasirox dispersible tablets (20 and 30 mg/kg) or deferoxamine (35 to 

≥50 mg/kg), the non-inferiority criteria were achieved. However, in patients with liver iron 

concentration <7 mg Fe/g dw treated with deferasirox dispersible tablets (5 and 10 mg/kg) or 

deferoxamine (20 to 35 mg/kg), non-inferiority was not established due to imbalance in the dosing of 

the two chelators. This imbalance occurred because patients on deferoxamine were allowed to remain 

on their pre-study dose even if it was higher than the protocol specified dose. Fifty-six patients under 

the age of 6 years participated in this pivotal study, 28 of them receiving deferasirox dispersible 

tablets. 

 



 

59 

It appeared from preclinical and clinical studies that deferasirox dispersible tablets could be as active 

as deferoxamine when used in a dose ratio of 2:1 (i.e. a dose of deferasirox dispersible tablets that is 

numerically half of the deferoxamine dose). For deferasirox granules, a dose ratio of 3:1 can be 

considered (i.e. a dose of deferasirox granules that is numerically one third of the deferoxamine dose). 

However, this dosing recommendation was not prospectively assessed in the clinical studies. 

 

In addition, in patients with liver iron concentration ≥7 mg Fe/g dw with various rare anaemias or 

sickle cell disease, deferasirox dispersible tablets up to 20 and 30 mg/kg produced a decrease in liver 

iron concentration and serum ferritin comparable to that obtained in patients with beta-thalassaemia. 

 

A placebo-controlled randomised study was performed in 225 patients with MDS (Low/Int-1 risk) and 

transfusional iron overload. The results of this study suggest that there is a positive impact of 

deferasirox on event-free survival (EFS, a composite endpoint including non-fatal cardiac or liver 

events) and serum ferritin levels. The safety profile was consistent with previous studies in adult MDS 

patients. 

 

In a 5-year observational study in which 267 children aged 2 to <6 years (at enrollment) with 

transfusional haemosiderosis received deferasirox, there were no clinically meaningful differences in 

the safety and tolerability profile of Exjade in paediatric patients aged 2 to <6 years compared to the 

overall adult and older paediatric population, including increases in serum creatinine of >33% and 

above the upper limit of normal on ≥2 consecutive occasions (3.1%), and elevation of alanine 

aminotransferase (ALT) greater than 5 times the upper limit of normal (4.3%). Single events of 

increase in ALT and aspartate aminotransferase were reported in 20.0% and 8.3%, respectively, of the 

145 patients who completed the study. 

 

In a study to assess the safety of deferasirox film-coated and dispersible tablets, 173 adult and 

paediatric patients with transfusion dependent thalassaemia or myelodysplastic syndrome were treated 

for 24 weeks. A comparable safety profile for film-coated and dispersible tablets was observed. 

 

In patients with non-transfusion-dependent thalassaemia syndromes and iron overload, treatment with 

deferasirox dispersible tablets was assessed in a 1-year, randomised, double-blind, placebo-controlled 

study. The study compared the efficacy of two different deferasirox dispersible tablet regimens 

(starting doses of 5 and 10 mg/kg/day, 55 patients in each arm) and of matching placebo (56 patients). 

The study enrolled 145 adult and 21 paediatric patients. The primary efficacy parameter was the 

change in liver iron concentration (LIC) from baseline after 12 months of treatment. One of the 

secondary efficacy parameters was the change in serum ferritin between baseline and fourth quarter. 

At a starting dose of 10 mg/kg/day, deferasirox dispersible tablets led to reductions in indicators of 

total body iron. On average, liver iron concentration decreased by 3.80 mg Fe/g dw in patients treated 

with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 0.38 mg Fe/g dw in 

patients treated with placebo (p<0.001). On average, serum ferritin decreased by 222.0 µg/l in patients 

treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 115 µg/l in 

patients treated with placebo (p<0.001). 

 

5.2 Pharmacokinetic properties 
 

EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet 

formulation. After adjustment of the strength, the granules formulation (4 x 90 mg strength) was 

equivalent to EXJADE dispersible tablets (500 mg strength) with respect to the mean area under the 

plasma concentration time curve (AUC) under fasting conditions. The Cmax was increased by 34% 

(90% CI: 27.9% - 40.3%); however a clinical exposure/response analysis revealed no evidence of 

clinically relevant effects of such an increase. 

 



 

60 

Absorption 

Deferasirox (dispersible tablet formulation) is absorbed following oral administration with a median 

time to maximum plasma concentration (tmax) of about 1.5 to 4 hours. The absolute bioavailability 

(AUC) of deferasirox (dispersible tablet formulation) is about 70% compared to an intravenous dose. 

The absolute bioavailability of the granule formulation has not been determined. Bioavailability of 

deferasirox granules was 52% greater than that with dispersible tablets. 

 

A food-effect study involving administration of the granules to healthy volunteers under fasting 

conditions and with a low-fat (fat content = approximately 30% of calories) or high-fat (fat content 

>50% of calories) meal indicated that the AUC and Cmax were slightly decreased after a low-fat meal 

(by 10% and 11%, respectively). After a high-fat meal, only AUC was mildly increased (by 18%). 

When the granules were administered with apple sauce or yogurt, a food effect was absent. 

 

Distribution 

Deferasirox is highly (99%) protein bound to plasma proteins, almost exclusively serum albumin, and 

has a small volume of distribution of approximately 14 litres in adults. 

 

Biotransformation 

Glucuronidation is the main metabolic pathway for deferasirox, with subsequent biliary excretion. 

Deconjugation of glucuronidates in the intestine and subsequent reabsorption (enterohepatic recycling) 

is likely to occur: in a healthy volunteer study, the administration of cholestyramine after a single dose 

of deferasirox resulted in a 45% decrease in deferasirox exposure (AUC). 

 

Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3. CYP450-catalysed 

(oxidative) metabolism of deferasirox appears to be minor in humans (about 8%). No inhibition of 

deferasirox metabolism by hydroxyurea was observed in vitro. 

 

Elimination 

Deferasirox and its metabolites are primarily excreted in the faeces (84% of the dose). Renal excretion 

of deferasirox and its metabolites is minimal (8% of the dose). The mean elimination half-life (t1/2) 

ranged from 8 to 16 hours. The transporters MRP2 and MXR (BCRP) are involved in the biliary 

excretion of deferasirox. 

 

Linearity / non-linearity 

The Cmax and AUC0-24h of deferasirox increase approximately linearly with dose under steady-state 

conditions. Upon multiple dosing exposure increased by an accumulation factor of 1.3 to 2.3. 

 

Characteristics in patients 

Paediatric patients 

The overall exposure of adolescents (12 to ≤17 years) and children (2 to <12 years) to deferasirox after 

single and multiple doses was lower than that in adult patients. In children younger than 6 years old 

exposure was about 50% lower than in adults. Since dosing is individually adjusted according to 

response this is not expected to have clinical consequences. 

 

Gender 

Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males. 

Since dosing is individually adjusted according to response this is not expected to have clinical 

consequences. 

 

Elderly patients 

The pharmacokinetics of deferasirox have not been studied in elderly patients (aged 65 or older). 

 

Renal or hepatic impairment 

The pharmacokinetics of deferasirox have not been studied in patients with renal impairment. The 

pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the 

upper limit of the normal range. 

 



 

61 

In a clinical study using single doses of 20 mg/kg deferasirox dispersible tablets, the average exposure 

was increased by 16% in subjects with mild hepatic impairment (Child-Pugh Class A) and by 76% in 

subjects with moderate hepatic impairment (Child-Pugh Class B) compared to subjects with normal 

hepatic function. The average Cmax of deferasirox in subjects with mild or moderate hepatic 

impairment was increased by 22%. Exposure was increased 2.8-fold in one subject with severe hepatic 

impairment (Child-Pugh Class C) (see sections 4.2 and 4.4). 

 

5.3 Preclinical safety data 
 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential. The main findings were 

kidney toxicity and lens opacity (cataracts). Similar findings were observed in neonatal and juvenile 

animals. The kidney toxicity is considered mainly due to iron deprivation in animals that were not 

previously overloaded with iron. 

 

Tests of genotoxicity in vitro were negative (Ames test, chromosomal aberration test) while 

deferasirox caused formation of micronuclei in vivo in the bone marrow, but not liver, of 

non-iron-loaded rats at lethal doses. No such effects were observed in iron-preloaded rats. Deferasirox 

was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/- heterozygous 

mice in a 6-month study. 

 

The potential for toxicity to reproduction was assessed in rats and rabbits. Deferasirox was not 

teratogenic, but caused increased frequency of skeletal variations and stillborn pups in rats at high 

doses that were severely toxic to the non-iron-overloaded mother. Deferasirox did not cause other 

effects on fertility or reproduction. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Cellulose, microcrystalline 

Crospovidone 

Povidone 

Magnesium stearate 

Silica, colloidal anhydrous 

Poloxamer 

 

6.2 Incompatibilities 
 

Not applicable. 

 

6.3 Shelf life 
 

3 years 

 

6.4 Special precautions for storage 
 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 
 

Sachets of polyethylene terephthalate (PET)/Aluminium/polyethylene (PE) foil. 

 

Unit packs containing 30 sachets. 

 



 

62 

6.6 Special precautions for disposal 
 

No special requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EXJADE 90 mg granules 

EU/1/06/356/020 

 

EXJADE 180 mg granules 

EU/1/06/356/021 

 

EXJADE 360 mg granules 

EU/1/06/356/022 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 28 August 2006 

Date of latest renewal: 18 April 2016 

 

 

10. DATE OF REVISION OF THE TEXT 
 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu 

  

http://www.ema.europa.eu/


 

63 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 

 



 

64 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

Name and address of the manufacturer responsible for batch release 

 

EXJADE 125 mg, 250 mg and 500 mg dispersible tablets 

 

Novartis Pharma GmbH 

Roonstraße 25 

D-90429 Nuremberg 

Germany 

 

EXJADE 90 mg, 180 mg and 360 mg film-coated tablets 

 

Novartis Pharma GmbH 

Roonstraße 25 

D-90429 Nuremberg 

Germany 

 

Novartis Farmacéutica SA 

Ronda de Santa Maria 158 

08210 Barberà del Vallès, Barcelona 

Spain 

 

EXJADE 90 mg, 180 mg and 360 mg granules in sachet 

 

Novartis Pharma GmbH 

Roonstraße 25 

D-90429 Nuremberg 

Germany 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 

Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

 Periodic Safety Update Reports 
The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and and any subsequent updates published on the European medicines web-portal. 

 

 

  



 

65 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 Risk Management Plan (RMP) 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 

updates of the RMP. 

 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 

 Whenever the risk management system is modified, especially as the result of new information 
being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 

 

 Additional risk minimisation measures 
The MAH must inform the European Medicines Agency and the CHMP of the results of the 

surveillance programme in each Member State. 

 

Prior to launch of EXJADE in each Member State the Marketing Authorisation Holder (MAH) must 

agree about the content and format of the educational programme, including communication media, 

distribution modalities, and any other aspects of the programme, with the National Competent 

Authority. 

 

The educational programme is aimed to inform healthcare professionals and patients to minimise the 

risks of: 

 Non-compliance of the posology and biological monitoring 

 Medication errors due to switching between formulations (dispersible tablets and film-coated 
tablets/granules). 

 

The MAH shall ensure that, at launch, in each Member State where EXJADE is marketed, all 

healthcare professionals and patients who are expected to prescribe, dispense and use EXJADE are 

provided with the following educational package for all available formulations (e.g. dispersible tablets, 

film-coated tablets and granules) for all indications: 

 Physician educational material 

 Patient information pack 
 

Additional periodic distributions after launch should be performed, notably after substantial safety 

modifications of the product information justifying educational material updates. 

 

The MAH shall use distinct outer cartons, blisters and tablets for all formulations (dispersible tablets 

and film-coated tablets/granules). 

 

The physician educational material should contain: 

 The Summary of Product Characteristics 

 Guide for healthcare professionals 
 

The Guide for healthcare professionals shall contain the following key elements: 

 Description of available deferasirox formulations (e.g. dispersible tablets, film-coated tablets 

and granules) 

o Different posology regimen 

o Different conditions of administration 

o Dose conversion table when switching from one formulation to another 

 The recommended doses and the rules for starting treatment 

 The need to monitor serum ferritin monthly 
 



 

66 

 That deferasirox causes rises in serum creatinine in some patients 
o The need to monitor serum creatinine 

 On two occasions prior to initiation of treatment 

 Every week during the first month of initiation of treatment or after therapy 
modification 

 Monthly thereafter 
 

o The need to reduce by 10 mg/kg the dose if serum creatinine rises: 

 Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min) 

 Paediatrics: either >ULN or creatinine clearance falls to <LLN at two 
consecutive visits. 

 

o The need to interrupt treatment after a dose reduction if serum creatinine rises: 

 Adults and Paediatrics: remain >33% above baseline or creatinine clearance 
<LLN (90 ml/min) 

 

o The need to consider renal biopsy: 

 When serum creatinine is elevated and if another abnormality has been 
detected (e.g. proteinuria, signs of Fanconi syndrome). 

 

 The importance of measuring creatinine clearance 

 Brief overview of methods of measuring creatinine clearance 

 That rises in serum transaminases may occur in patients treated with EXJADE 
o The need for liver function tests prior to prescription, then at monthly intervals or 

more often if clinically indicated 

o Not to prescribe to patients with pre-existing severe hepatic disease 
o The need to interrupt treatment if persistent and progressive increase in liver enzyme 

were noted. 

 The need for annual auditory and ophthalmic testing 
 

 The need for a guidance table highlighting pre-treatment measurements of serum creatinine, 
creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as: 

 

Before initiating treatment  

Serum creatinine at Day - X Value 1 

Serum creatinine at Day - Y Value 2 

X and Y are the days (to be determined) when pre-treatment measurements should be performed. 

 

 A warning on the risk of overchelation and on the necessity of close monitoring of serum 
ferritin levels and renal and hepatic function. 

 

 The rules for treatment dose adjustments and interruption when target serum ferritin +/- liver 
iron concentration are reached. 

 

 Recommendations for treatment of non-transfusion-dependent thalassaemia (NTDT) 
syndromes: 

o Information that only one course of treatment is proposed for NTDT patients 
o A warning on the necessity of closer monitoring of liver iron concentration and serum 

ferritin in the paediatric population 

o A warning on the currently unknown safety consequences of long-term treatment in 
the paediatric population 

 



 

67 

Prior to launch of deferasirox film-coated tablets, healthcare professionals will receive introductory 

notification letters as follows: 

 Pharmacists - a detailed letter explaining the switch between formulations 

 Prescribers - a letter including the following dossiers: 
o A prescribers’ guide informing about the switch between formulations in order to 

address the important potential risk of medication error for deferasirox 

o A patient’s guide informing about the possibility of co-existing formulations in the 
EU market, and the differences concerning their administration, in order to address the 

important potential risk of medication error for deferasirox 

Additionally, prescribers and pharmacists will be informed via a specific letter regarding the timelines 

for removing EXJADE dispersible tablets from the EU market. 

 

The patient information pack should contain: 

 Patient information leaflet 

 Patient guide 
 

Patient guide should contain the following key elements: 

o Information on the need for regular monitoring, and when it should be carried out, of 
serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin 

o Information that renal biopsy may be considered if significant renal abnormalities 
occur 

o Availability of several oral formulations (e.g. dispersible tablets, film-coated tablets 
and granules) and the main differences associated with these formulations (i.e., 

different posology regimen, different conditions of administration notably with food) 

 

 Obligation to conduct post-authorisation measures 

 

The MAH shall complete, within the stated timeframe, the below measures: 

 

Description Due date 

Non-interventional post-authorisation safety study (PASS): In order to assess the 

long-term exposure and safety of deferasirox dispersible and film-coated tablets, 

the MAH should conduct an observational cohort study in paediatric 

non-transfusion-dependent thalassaemia patients over 10 years old for whom 

deferoxamine is contraindicated or inadequate conducted according to a 

CHMP-agreed protocol. The clinical study report should be submitted by 

June 2021 

 

  



 

68 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



 

69 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 
  



 

70 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

EXJADE 125 mg dispersible tablets 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each dispersible tablet contains 125 mg of deferasirox. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose. See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Dispersible tablets 

 

28 dispersible tablets 

84 dispersible tablets 

252 dispersible tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Take this medicine on an empty stomach. 

Disperse tablets in water or fruit juice before swallowing. Do not swallow whole or chew. 

Oral use. 

 

 
 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 



 

71 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/001 28 dispersible tablets 

EU/1/06/356/002 84 dispersible tablets 

EU/1/06/356/007 252 dispersible tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

EXJADE 125 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



 

72 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 
  



 

73 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

EXJADE 125 mg dispersible tablets 

deferasirox 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

  



 

74 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

EXJADE 250 mg dispersible tablets 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each dispersible tablet contains 250 mg of deferasirox. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose. See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Dispersible tablets 

 

28 dispersible tablets 

84 dispersible tablets 

252 dispersible tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Take this medicine on an empty stomach. 

Disperse tablets in water or fruit juice before swallowing. Do not swallow whole or chew. 

Oral use. 

 

 
 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 



 

75 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/003 28 dispersible tablets 

EU/1/06/356/004 84 dispersible tablets 

EU/1/06/356/008 252 dispersible tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

EXJADE 250 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



 

76 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 
  



 

77 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

EXJADE 250 mg dispersible tablets 

deferasirox 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 
Lot 

 

 

5. OTHER 

 

 

  



 

78 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

EXJADE 500 mg dispersible tablets 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each dispersible tablet contains 500 mg of deferasirox. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose. See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Dispersible tablets 

 

28 dispersible tablets 

84 dispersible tablets 

252 dispersible tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Take this medicine on an empty stomach. 

Disperse tablets in water or fruit juice before swallowing. Do not swallow whole or chew. 

Oral use. 

 

 
 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 



 

79 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/005 28 dispersible tablets 

EU/1/06/356/006 84 dispersible tablets 

EU/1/06/356/009 252 dispersible tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

EXJADE 500 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



 

80 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 
 

 

  



 

81 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (including blue box) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

EXJADE 500 mg dispersible tablets 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each dispersible tablet contains 500 mg of deferasirox. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose. See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Dispersible tablets 

 

Multipack: 294 (3 packs of 98) dispersible tablets. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Take this medicine on an empty stomach. 

Disperse tablets in water or fruit juice before swallowing. Do not swallow whole or chew. 

Oral use. 

 

 
 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 



 

82 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/010 294 (3 packs of 98) dispersible tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

EXJADE 500 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN:  



 

83 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (without blue box) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

EXJADE 500 mg dispersible tablets 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each dispersible tablet contains 500 mg of deferasirox. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose. See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Dispersible tablets 

 

98 dispersible tablets. Component of a multipack. Cannot be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Take this medicine on an empty stomach. 

Disperse tablets in water or fruit juice before swallowing. Do not swallow whole or chew. 

Oral use. 

 

 
 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 



 

84 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/010 294 (3 packs of 98) dispersible tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

EXJADE 500 mg 

  



 

85 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

EXJADE 500 mg dispersible tablets 

deferasirox 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 
Lot 

 

 

5. OTHER 

 

 

  



 

86 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 90 mg film-coated tablets 

 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 90 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 
30 film-coated tablets 

90 film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

87 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/011   30 film-coated tablets 

EU/1/06/356/012   90 film-coated tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 90 mg 
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 
  



 

88 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 90 mg film-coated tablets 

 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 90 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 
Multipack: 300 (10 packs of 30) film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

89 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/013   300 (10 packs of 30) film-coated tablets 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 90 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



 

90 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 90 mg film-coated tablets 

 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 90 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 
30 film-coated tablets. Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

91 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/013   300 (10 packs of 30) film-coated tablets 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 90 mg 

  



 

92 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 90 mg film-coated tablets 
deferasirox 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 
 

 

5. OTHER 

 

  



 

93 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 180 mg film-coated tablets 

 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 180 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 
30 film-coated tablets 

90 film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

94 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/014   30 film-coated tablets 

EU/1/06/356/015   90 film-coated tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 180 mg 
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 
  



 

95 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 180 mg film-coated tablets 

 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 180 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 
Multipack: 300 (10 packs of 30) film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

96 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/016   300 (10 packs of 30) film-coated tablets 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 180 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



 

97 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 180 mg film-coated tablets 

 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 180 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 
30 film-coated tablets. Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

98 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/016   300 (10 packs of 30) film-coated tablets 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 180 mg 

  



 

99 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 180 mg film-coated tablets 
deferasirox 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 
 

 

5. OTHER 

 

  



 

100 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 360 mg film-coated tablets 

 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 360 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 
30 film-coated tablets 

90 film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

101 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/017   30 film-coated tablets 

EU/1/06/356/018   90 film-coated tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 360 mg 
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 
  



 

102 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 360 mg film-coated tablets 

 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 360 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 
Multipack: 300 (10 packs of 30) film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

103 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/019   300 (10 packs of 30) film-coated tablets 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 360 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 
  



 

104 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 360 mg film-coated tablets 

 

deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains 360 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 
30 film-coated tablets. Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

105 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/019   300 (10 packs of 30) film-coated tablets 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 360 mg 

  



 

106 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 360 mg film-coated tablets 
deferasirox 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 
 

 

5. OTHER 

 

  



 

107 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 90 mg granules in sachet 
deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each sachet contains 90 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Granules in sachet 

 
30 sachets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

108 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/020 30 sachets 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 90 mg 

 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 
  



 

109 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHETS 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Exjade 90 mg granules 
deferasirox 

Oral use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 
 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

162 mg 

 
 

6. OTHER 

 

  



 

110 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 180 mg granules in sachet 
deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each sachet contains 180 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Granules in sachet 

 
30 sachets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

111 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/021 30 sachets 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 180 mg 

 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 
  



 

112 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHETS 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Exjade 180 mg granules 
deferasirox 

Oral use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 
 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

324 mg 

 
 

6. OTHER 

 

  



 

113 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Exjade 360 mg granules in sachet 
deferasirox 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each sachet contains 360 mg of deferasirox. 
 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Granules in sachet 

 
30 sachets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

114 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/06/356/022 30 sachets 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Exjade 360 mg 

 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 
  



 

115 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SACHETS 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Exjade 360 mg granules 
deferasirox 

Oral use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 
 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

648 mg 

 
 

6. OTHER 

 

  



 

116 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



 

117 

Package leaflet: Information for the user 

 

EXJADE 125 mg dispersible tablets 

EXJADE 250 mg dispersible tablets 

EXJADE 500 mg dispersible tablets 

Deferasirox 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 
 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed only for you or your child. Do not pass it on to others. It may 

harm them, even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 
1. What EXJADE is and what it is used for 

2. What you need to know before you take EXJADE 

3. How to take EXJADE 

4. Possible side effects 

5. How to store EXJADE 

6. Contents of the pack and other information 

 

 

1. What EXJADE is and what it is used for 
 

What EXJADE is 

EXJADE contains an active substance called deferasirox. It is an iron chelator which is a medicine 

used to remove the excess iron from the body (also called iron overload). It traps and removes excess 

iron which is then excreted mainly in the stools. 

 

What EXJADE is used for 

Repeated blood transfusions may be necessary in patients with various types of anaemia (for example 

thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)). However, repeated blood 

transfusions can cause a build-up of excess iron. This is because blood contains iron and your body 

does not have a natural way to remove the excess iron you get with your blood transfusions. In 

patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over 

time, mainly due to increased absorption of dietary iron in response to low blood cell counts. Over 

time, the excess iron can damage important organs such as the liver and heart. Medicines called iron 

chelators are used to remove the excess iron and reduce the risk of it causing organ damage. 

 

EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with 

beta thalassaemia major aged 6 years and older. 

 

EXJADE is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or 

inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood 

transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years. 

 

EXJADE is also used when deferoxamine therapy is contraindicated or inadequate to treat patients 

aged 10 years or older who have iron overload associated with their thalassaemia syndromes, but who 

are not transfusion dependent. 

 



 

118 

 

2. What you need to know before you take EXJADE 
 

Do not take EXJADE 
- if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in 

section 6). If this applies to you, tell your doctor before taking EXJADE. If you think you 

may be allergic, ask your doctor for advice. 

- if you have moderate or severe kidney disease. 
- if you are currently taking any other iron chelator medicines. 
 

EXJADE is not recommended 

- if you are at an advanced stage of myelodysplastic syndrome (MDS; decreased production of 
blood cells by the bone marrow) or have advanced cancer. 

 

Warnings and precautions 

Talk to your doctor or pharmacist before taking EXJADE: 

- if you have a kidney or liver problem. 

- if you have a cardiac problem due to iron overload. 

- if you notice a marked decrease in your urine output (sign of kidney problem). 

- if you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face 

and throat (signs of severe allergic reaction, see also section 4 “Possible side effects”). 

- if you experience a combination of any of the following symptoms: rash, red skin, blistering of 

the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes 

(signs of severe skin reaction, see also section 4 “Possible side effects”). 

- if you experience a combination of drowsiness, upper right abdominal pain, yellowing or 

increased yellowing of your skin or eyes and dark urine (signs of liver problems). 

- if you experience difficulty thinking, remembering information, or solving problems, being less 

alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your 

blood, which may be associated with liver or renal problems, see also section 4 “Possible side 

effects”). 

- if you vomit blood and/or have black stools. 

- if you experience frequent abdominal pain, particularly after eating or taking EXJADE. 

- if you experience frequent heartburn. 

- if you have a low level of platelets or white blood cells in your blood test. 

- if you have blurred vision. 

- if you have diarrhoea or vomiting. 

If any of these apply to you, tell your doctor straight away. 

 

Monitoring your EXJADE treatment 

You will have regular blood and urine tests during treatment. These will monitor the amount of iron in 

your body (blood level of ferritin) to see how well EXJADE is working. The tests will also monitor 

your kidney function (blood level of creatinine, presence of protein in the urine) and liver function 

(blood level of transaminases). Your doctor may require you to undergo a kidney biopsy, if he/she 

suspects significant kidney damage. You may also have MRI (magnetic resonance imaging) tests to 

determine the amount of iron in your liver. Your doctor will take these tests into consideration when 

deciding on the dose of EXJADE most suitable for you and will also use these tests to decide when 

you should stop taking EXJADE. 

 

Your eyesight and hearing will be tested each year during treatment as a precautionary measure. 

 

  



 

119 

Other medicines and EXJADE 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. This includes in particular: 

- other iron chelators, which must not be taken with EXJADE, 

- antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at 

the same time of day as EXJADE, 

- ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such 

as rheumatoid arthritis or atopic dermatitis), 

- simvastatin (used to lower cholesterol), 

- certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids), 

- oral bisphosphonates (used to treat osteoporosis), 

- anticoagulant medicines (used to prevent or treat blood clotting), 

- hormonal contraceptive agents (birth control medicines), 

- bepridil, ergotamine (used for heart problems and migraines), 

- repaglinide (used to treat diabetes), 

- rifampicin (used to treat tuberculosis), 

- phenytoin, phenobarbital, carbamazepine (used to treat epilepsy), 

- ritonavir (used in the treatment of HIV infection), 

- paclitaxel (used in cancer treatment), 

- theophylline (used to treat respiratory diseases such as asthma), 

- clozapine (used to treat psychiatric disorders such as schizophrenia), 

- tizanidine (used as a muscle relaxant), 

- cholestyramine (used to lower cholesterol levels in the blood), 

- busulfan (used as a treatment prior to transplantation in order to destroy the original bone 

marrow before the transplant). 

 

Additional tests may be required to monitor the blood levels of some of these medicines. 

 

Older people (age 65 years and over) 
EXJADE can be used by people aged 65 years and over at the same dose as for other adults. Elderly 

patients may experience more side effects (in particular diarrhoea) than younger patients. They should 

be monitored closely by their doctor for side effects that may require a dose adjustment. 

 

Children and adolescents 

EXJADE can be used in children and adolescents receiving regular blood transfusions aged 2 years 

and over and in children and adolescents not receiving regular blood transfusions aged 10 years and 

over. As the patient grows the doctor will adjust the dose. 

 

EXJADE is not recommended for children aged under 2 years. 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor for advice before taking this medicine. 

 

EXJADE is not recommended during pregnancy unless clearly necessary. 

 

If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, 

you should use an additional or different type of contraception (e.g. condom), as EXJADE may reduce 

the effectiveness of oral and patch contraceptives. 

 

Breast-feeding is not recommended during treatment with EXJADE. 

 

Driving and using machines 
If you feel dizzy after taking EXJADE, do not drive or operate any tools or machines until you are 

feeling normal again. 

 



 

120 

EXJADE contains lactose 

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 

before taking this medicine. 

 

 

3. How to take EXJADE 
 

Treatment with EXJADE will be overseen by a doctor who is experienced in the treatment of iron 

overload caused by blood transfusions. 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 

if you are not sure. 

 

How much EXJADE to take 

The dose of EXJADE is related to body weight for all patients. Your doctor will calculate the dose you 

need and tell you how many tablets to take each day. 

 The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients 
receiving regular blood transfusions is 20 mg per kilogram body weight. A higher or lower 

starting dose may be recommended by your doctor based on your individual treatment needs. 

 The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients not 

receiving regular blood transfusions is 10 mg per kilogram body weight. 

 Depending on how you respond to treatment, your doctor may later adjust your treatment to a 
higher or lower dose. 

 The maximum recommended daily dose for EXJADE dispersible tablets is 40 mg per kilogram 
body weight for patients receiving regular blood transfusions, 20 mg per kilogram body weight 

for adult patients not receiving regular blood transfusions and 10 mg per kilogram body weight 

for children and adolescents not receiving regular blood transfusions. 

 

Deferasirox also comes as “film-coated” tablets and granules. If you are switching from the 

film-coated tablets or granules to these dispersible tablets, you will need an adjustment of the dose. 

 

When to take EXJADE 

 Take EXJADE once a day, every day, at about the same time each day. 

 Take the EXJADE dispersible tablets on an empty stomach. 

 Then wait at least 30 minutes before eating any food. 
Taking EXJADE at the same time each day will also help you remember when to take your tablets. 

 

How to take EXJADE: 

 Drop the tablet(s) into a glass of water, or apple or orange juice 
(100 to 200 ml). 

 Stir until the tablet(s) dissolve completely. The liquid in the glass 
will look cloudy. 

 Drink everything in the glass. Then add a little water or juice to 
what is left in the glass, swirl the liquid around and drink that too. 

 
Do not dissolve the tablets in fizzy drinks or milk. 
Do not chew, break or crush the tablets. 
Do not swallow the tablets whole. 
 

 
 

 
 

 
 

 



 

121 

How long to take EXJADE 

Continue taking EXJADE every day for as long as your doctor tells you. This is a long-term 

treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to 

check that the treatment is having the desired effect (see also section 2: “Monitoring your EXJADE 

treatment”). 

 

If you have questions about how long to take EXJADE, talk to your doctor. 

 

If you take more EXJADE than you should 
If you have taken too much EXJADE, or if someone else accidentally takes your tablets, contact your 

doctor or hospital for advice straight away. Show the doctor the pack of tablets. Urgent medical 

treatment may be necessary. You may experience effects such as abdominal pain, diarrhoea, nausea 

and vomiting and kidney or liver problems that can be serious. 

 

If you forget to take EXJADE 
If you miss a dose, take it as soon as you remember on that day. Take your next dose as scheduled. Do 

not take a double dose on the next day to make up for the forgotten tablet(s). 

 

If you stop taking EXJADE 
Do not stop taking EXJADE unless your doctor tells you to. If you stop taking it, the excess iron will 

no longer be removed from your body (see also above section “How long to take EXJADE”). 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of 

the side effects are mild to moderate and will generally disappear after a few days to a few weeks of 

treatment. 

 

Some side effects could be serious and need immediate medical attention. 

These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 

1,000 people). 

 If you get a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and 
throat (signs of severe allergic reaction), 

 If you experience a combination of any of the following symptoms: rash, red skin, blistering of 
the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes, 

(signs of severe skin reactions), 

 If you notice a marked decrease in your urine output (sign of kidney problem), 

 If you experience a combination of drowsiness, upper right abdominal pain, yellowing or 
increased yellowing of your skin or eyes and dark urine (signs of liver problems), 

 If you experience difficulty thinking, remembering information, or solving problems, being less 
alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your 

blood, which may be associated with liver or renal problems and lead to a change in your brain 

function), 

 If you vomit blood and/or have black stools, 

 If you experience frequent abdominal pain, particularly after eating or taking EXJADE, 

 If you experience frequent heartburn, 

 If you experience partial loss of vision, 

 If you experience severe upper stomach pain (pancreatitis), 
stop taking this medicine and tell your doctor straight away. 

 

Some side effects could become serious. 

These side effects are uncommon. 

 If you get blurred or cloudy eyesight, 

 If you get reduced hearing, 
tell your doctor as soon as possible. 



 

122 

 

Other side effects 
Very common (may affect more than 1 in 10 people) 

 Disturbance in kidney function tests. 
 

Common (may affect up to 1 in 10 people) 

 Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating, 
constipation, indigestion 

 Rash 

 Headache 

 Disturbance in liver function tests 

 Itching 

 Disturbance in urine test (protein in the urine) 
If any of these affects you severely, tell your doctor. 

 

Uncommon (may affect up to 1 in 100 people) 

 Dizziness 

 Fever 

 Sore throat 

 Swelling of arms or legs 

 Change in the colour of the skin 

 Anxiety 

 Sleep disorder 

 Tiredness 
If any of these affects you severely, tell your doctor. 

 

Frequency not known (cannot be estimated from the available data). 

 A decrease in the number of cells involved in blood clotting (thrombocytopenia), in the number 
of red blood cells (anaemia aggravated), in the number of white blood cells (neutropenia) or in 

the number of all kinds of blood cells (pancytopenia) 

 Hair loss 

 Kidney stones 

 Low urine output 

 Tear in stomach or intestine wall that can be painful and cause nausea 

 Severe upper stomach pain (pancreatitis) 

 Abnormal level of acid in blood 
 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

5. How to store EXJADE 
 

 Keep this medicine out of the sight and reach of children. 

 Do not use this medicine after the expiry date which is stated on the blister and the carton after 
EXP. The expiry date refers to the last day of that month. 

 Store in the original package in order to protect from moisture. 

 Do not use any pack that is damaged or shows signs of tampering. 

 Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 
how to throw away medicines you no longer use. These measures will help protect the 

environment. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

123 

 

6. Contents of the pack and other information 

 

What EXJADE contains 

The active substance is deferasirox. 

 Each dispersible tablet of EXJADE 125 mg contains 125 mg deferasirox. 

 Each dispersible tablet of EXJADE 250 mg contains 250 mg deferasirox. 

 Each dispersible tablet of EXJADE 500 mg contains 500 mg deferasirox. 
The other ingredients are lactose monohydrate, crospovidone type A, povidone, sodium laurilsulfate, 

microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate. 

 

What EXJADE looks like and contents of the pack 

EXJADE is supplied as dispersible tablets. The tablets are white to slightly yellow, round and flat. 

 EXJADE 125 mg tablets are stamped “J 125” on one side and “NVR” on the other. 

 EXJADE 250 mg tablets are stamped “J 250” on one side and “NVR” on the other. 

 EXJADE 500 mg tablets are stamped “J 500” on one side and “NVR” on the other. 
 

EXJADE 125 mg, 250 mg and 500 mg dispersible tablets are available in unit packs containing 28, 

84 or 252 dispersible tablets. 

EXJADE 500 mg dispersible tablets are also available in multipacks containing 294 (3 packs of 

98) dispersible tablets. 

Not all pack sizes or strengths may be available in your country. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Pharma GmbH 

Roonstraße 25 

D-90429 Nuremberg 

Germany 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België/Belgique/Belgien 
Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 
Novartis Pharma Services Inc. 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 
Novartis Pharma N.V 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 
Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 
Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 



 

124 

Deutschland 
Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 
Novartis Pharma B.V. 

Tel: +31 26 37 82 555 

Eesti 

Novartis Pharma Services Inc. 

Tel: +372 66 30 810 

 

Norge 
Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 
Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 
Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 
Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 
Tel: +40 21 31299 01 

Ireland 
Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 
Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 
Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 
Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA “Novartis Baltics” 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

This leaflet was last revised in 

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency website: 

http://www.ema.europa.eu 

 

http://www.ema.europa.eu/


 

125 

Package leaflet: Information for the user 

 

EXJADE 90 mg film-coated tablets 

EXJADE 180 mg film-coated tablets 

EXJADE 360 mg film-coated tablets 

Deferasirox 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 
 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed only for you or your child. Do not pass it on to others. It may 

harm them, even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 
1. What EXJADE is and what it is used for 

2. What you need to know before you take EXJADE 

3. How to take EXJADE 

4. Possible side effects 

5. How to store EXJADE 

6. Contents of the pack and other information 

 

 

1. What EXJADE is and what it is used for 
 

What EXJADE is 

EXJADE contains an active substance called deferasirox. It is an iron chelator which is a medicine 

used to remove the excess iron from the body (also called iron overload). It traps and removes excess 

iron which is then excreted mainly in the stools. 

 

What EXJADE is used for 

Repeated blood transfusions may be necessary in patients with various types of anaemia (for example 

thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)). However, repeated blood 

transfusions can cause a build-up of excess iron. This is because blood contains iron and your body 

does not have a natural way to remove the excess iron you get with your blood transfusions. In 

patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over 

time, mainly due to increased absorption of dietary iron in response to low blood cell counts. Over 

time, the excess iron can damage important organs such as the liver and heart. Medicines called iron 

chelators are used to remove the excess iron and reduce the risk of it causing organ damage. 

 

EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with 

beta thalassaemia major aged 6 years and older. 

 

EXJADE is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or 

inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood 

transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years. 

 

EXJADE is also used when deferoxamine therapy is contraindicated or inadequate to treat patients 

aged 10 years or older who have iron overload associated with their thalassaemia syndromes, but who 

are not transfusion dependent. 

 



 

126 

 

2. What you need to know before you take EXJADE 
 

Do not take EXJADE 
- if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in 

section 6). If this applies to you, tell your doctor before taking EXJADE. If you think you 

may be allergic, ask your doctor for advice. 

- if you have moderate or severe kidney disease. 
- if you are currently taking any other iron chelator medicines. 
 

EXJADE is not recommended 

- if you are at an advanced stage of myelodysplastic syndrome (MDS; decreased production of 
blood cells by the bone marrow) or have advanced cancer. 

 

Warnings and precautions 

Talk to your doctor or pharmacist before taking EXJADE: 

- if you have a kidney or liver problem. 

- if you have a cardiac problem due to iron overload. 

- if you notice a marked decrease in your urine output (sign of kidney problem). 

- if you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face 

and throat (signs of severe allergic reaction, see also section 4 “Possible side effects”). 

- if you experience a combination of any of the following symptoms: rash, red skin, blistering of 

the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes 

(signs of severe skin reaction, see also section 4 “Possible side effects”). 

- if you experience a combination of drowsiness, upper right abdominal pain, yellowing or 

increased yellowing of your skin or eyes and dark urine (signs of liver problems). 

- if you experience difficulty thinking, remembering information, or solving problems, being less 

alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your 

blood, which may be associated with liver or renal problems, see also section 4 “Possible side 

effects”). 

- if you vomit blood and/or have black stools. 

- if you experience frequent abdominal pain, particularly after eating or taking EXJADE. 

- if you experience frequent heartburn. 

- if you have a low level of platelets or white blood cells in your blood test. 

- if you have blurred vision 

- if you have diarrhoea or vomiting. 

If any of these apply to you, tell your doctor straight away. 

 

Monitoring your EXJADE treatment 

You will have regular blood and urine tests during treatment. These will monitor the amount of iron in 

your body (blood level of ferritin) to see how well EXJADE is working. The tests will also monitor 

your kidney function (blood level of creatinine, presence of protein in the urine) and liver function 

(blood level of transaminases). Your doctor may require you to undergo a kidney biopsy, if he/she 

suspects significant kidney damage. You may also have MRI (magnetic resonance imaging) tests to 

determine the amount of iron in your liver. Your doctor will take these tests into consideration when 

deciding on the dose of EXJADE most suitable for you and will also use these tests to decide when 

you should stop taking EXJADE. 

 

Your eyesight and hearing will be tested each year during treatment as a precautionary measure. 

 

  



 

127 

Other medicines and EXJADE 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. This includes in particular: 

- other iron chelators, which must not be taken with EXJADE, 

- antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at 

the same time of day as EXJADE, 

- ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such 

as rheumatoid arthritis or atopic dermatitis), 

- simvastatin (used to lower cholesterol), 

- certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids), 

- oral bisphosphonates (used to treat osteoporosis), 

- anticoagulant medicines (used to prevent or treat blood clotting), 

- hormonal contraceptive agents (birth control medicines), 

- bepridil, ergotamine (used for heart problems and migraines), 

- repaglinide (used to treat diabetes), 

- rifampicin (used to treat tuberculosis), 

- phenytoin, phenobarbital, carbamazepine (used to treat epilepsy), 

- ritonavir (used in the treatment of HIV infection), 

- paclitaxel (used in cancer treatment), 

- theophylline (used to treat respiratory diseases such as asthma), 

- clozapine (used to treat psychiatric disorders such as schizophrenia), 

- tizanidine (used as a muscle relaxant), 

- cholestyramine (used to lower cholesterol levels in the blood), 

- busulfan (used as a treatment prior to transplantation in order to destroy the original bone 

marrow before the transplant). 

 

Additional tests may be required to monitor the blood levels of some of these medicines. 

 

Older people (age 65 years and over) 
EXJADE can be used by people aged 65 years and over at the same dose as for other adults. Elderly 

patients may experience more side effects (in particular diarrhoea) than younger patients. They should 

be monitored closely by their doctor for side effects that may require a dose adjustment. 

 

Children and adolescents 

EXJADE can be used in children and adolescents receiving regular blood transfusions aged 2 years 

and over and in children and adolescents not receiving regular blood transfusions aged 10 years and 

over. As the patient grows the doctor will adjust the dose. 

 

EXJADE is not recommended for children aged under 2 years. 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor for advice before taking this medicine. 

 

EXJADE is not recommended during pregnancy unless clearly necessary. 

 

If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, 

you should use an additional or different type of contraception (e.g. condom), as EXJADE may reduce 

the effectiveness of oral and patch contraceptives. 

 

Breast-feeding is not recommended during treatment with EXJADE. 

 

Driving and using machines 
If you feel dizzy after taking EXJADE, do not drive or operate any tools or machines until you are 

feeling normal again. 

 

 



 

128 

3. How to take EXJADE 
 

Treatment with EXJADE will be overseen by a doctor who is experienced in the treatment of iron 

overload caused by blood transfusions. 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 

if you are not sure. 

 

How much EXJADE to take 

The dose of EXJADE is related to body weight for all patients. Your doctor will calculate the dose you 

need and tell you how many tablets to take each day. 

 The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients 
receiving regular blood transfusions is 14 mg per kilogram body weight. A higher or lower 

starting dose may be recommended by your doctor based on your individual treatment needs. 

 The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients 

not receiving regular blood transfusions is 7 mg per kilogram body weight. 

 Depending on how you respond to treatment, your doctor may later adjust your treatment to a 
higher or lower dose. 

 The maximum recommended daily dose for EXJADE film-coated tablets is: 

 28 mg per kilogram body weight for patients receiving regular blood transfusions, 

 14 mg per kilogram body weight for adult patients not receiving regular blood 
transfusions, 

 7 mg per kilogram body weight for children and adolescents not receiving regular blood 
transfusions. 

 

Deferasirox also comes as “dispersible” tablets. If you are switching from the dispersible tablets to 

these film-coated tablets, you will need an adjustment of the dose. 

 

When to take EXJADE 

 Take EXJADE once a day, every day, at about the same time each day with some water. 

 Take EXJADE film-coated tablets either on an empty stomach or with a light meal. 
Taking EXJADE at the same time each day will also help you remember when to take your tablets. 

 

For patients who are unable to swallow whole tablets, EXJADE film-coated tablets may be crushed 

and taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple). The 

food should be immediately and completely consumed. Do not store it for future use. 

 

How long to take EXJADE 

Continue taking EXJADE every day for as long as your doctor tells you. This is a long-term 

treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to 

check that the treatment is having the desired effect (see also section 2: “Monitoring your EXJADE 

treatment”). 

 

If you have questions about how long to take EXJADE, talk to your doctor. 

 

If you take more EXJADE than you should 
If you have taken too much EXJADE, or if someone else accidentally takes your tablets, contact your 

doctor or hospital for advice straight away. Show the doctor the pack of tablets. Urgent medical 

treatment may be necessary. You may experience effects such as abdominal pain, diarrhoea, nausea 

and vomiting and kidney or liver problems that can be serious. 

 

If you forget to take EXJADE 
If you miss a dose, take it as soon as you remember on that day. Take your next dose as scheduled. Do 

not take a double dose on the next day to make up for the forgotten tablet(s). 

 



 

129 

If you stop taking EXJADE 
Do not stop taking EXJADE unless your doctor tells you to. If you stop taking it, the excess iron will 

no longer be removed from your body (see also above section “How long to take EXJADE”). 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of 

the side effects are mild to moderate and will generally disappear after a few days to a few weeks of 

treatment. 

 

Some side effects could be serious and need immediate medical attention. 

These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 

1,000 people). 

 If you get a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and 
throat (signs of severe allergic reaction), 

 If you experience a combination of any of the following symptoms: rash, red skin, blistering of 
the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes, 

(signs of severe skin reactions), 

 If you notice a marked decrease in your urine output (sign of kidney problem), 

 If you experience a combination of drowsiness, upper right abdominal pain, yellowing or 
increased yellowing of your skin or eyes and dark urine (signs of liver problems), 

 If you experience difficulty thinking, remembering information, or solving problems, being less 
alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your 

blood, which may be associated with liver or renal problems and lead to a change in your brain 

function), 

 If you vomit blood and/or have black stools, 

 If you experience frequent abdominal pain, particularly after eating or taking EXJADE, 

 If you experience frequent heartburn, 

 If you experience partial loss of vision, 

 If you experience severe upper stomach pain (pancreatitis), 
stop taking this medicine and tell your doctor straight away. 

 

Some side effects could become serious. 

These side effects are uncommon. 

 If you get blurred or cloudy eyesight, 

 If you get reduced hearing, 
tell your doctor as soon as possible. 

 

Other side effects 

Very common (may affect more than 1 in 10 people) 

 Disturbance in kidney function tests. 
 

Common (may affect up to 1 in 10 people) 

 Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating, 
constipation, indigestion 

 Rash 

 Headache 

 Disturbance in liver function tests 

 Itching 

 Disturbance in urine test (protein in the urine) 
If any of these affects you severely, tell your doctor. 

 

  



 

130 

Uncommon (may affect up to 1 in 100 people) 

 Dizziness 

 Fever 

 Sore throat 

 Swelling of arms or legs 

 Change in the colour of the skin 

 Anxiety 

 Sleep disorder 

 Tiredness 
If any of these affects you severely, tell your doctor. 

 

Frequency not known (cannot be estimated from the available data). 

 A decrease in the number of cells involved in blood clotting (thrombocytopenia), in the number 
of red blood cells (anaemia aggravated), in the number of white blood cells (neutropenia) or in 

the number of all kinds of blood cells (pancytopenia) 

 Hair loss 

 Kidney stones 

 Low urine output 

 Tear in stomach or intestine wall that can be painful and cause nausea 

 Severe upper stomach pain (pancreatitis) 

 Abnormal level of acid in blood 
 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

5. How to store EXJADE 
 

 Keep this medicine out of the sight and reach of children. 

 Do not use this medicine after the expiry date which is stated on the blister and the carton after 
EXP. The expiry date refers to the last day of that month. 

 Do not use any pack that is damaged or shows signs of tampering. 

 Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 
how to throw away medicines you no longer use. These measures will help protect the 

environment. 

 

 

6. Contents of the pack and other information 

 

What EXJADE contains 

The active substance is deferasirox. 

 Each film-coated tablet of EXJADE 90 mg contains 90 mg deferasirox. 

 Each film-coated tablet of EXJADE 180 mg contains 180 mg deferasirox. 

 Each film-coated tablet of EXJADE 360 mg contains 360 mg deferasirox. 
The other ingredients are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; 

colloidal anhydrous silica and poloxamer. The tablet coating material contains: hypromellose; titanium 

dioxide (E171); macrogol (4000); talc; indigo carmine aluminium lake (E132). 

 

  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

131 

What EXJADE looks like and contents of the pack 

EXJADE is supplied as film-coated tablets. The film-coated tablets are ovaloid and biconvex. 

 EXJADE 90 mg film-coated tablets are light blue and stamped “90” on one side and “NVR” on 
the other. 

 EXJADE 180 mg film-coated tablets are medium blue and stamped “180” on one side and 
“NVR” on the other. 

 EXJADE 360 mg film-coated tablets are dark blue and stamped “360” on one side and “NVR” 
on the other. 

 

Each blister pack contains 30 or 90 film-coated tablets. The multipacks contain 300 (10 packs of 30) 

film-coated tablets. 

 

Not all pack sizes or strengths may be available in your country. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Pharma GmbH 

Roonstraße 25 

D-90429 Nuremberg 

Germany 

 

Novartis Farmacéutica SA 

Ronda de Santa Maria 158 

08210 Barberà del Vallès, Barcelona 

Spain 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België/Belgique/Belgien 
Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 
Novartis Pharma Services Inc. 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 
Novartis Pharma N.V 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 
Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 
Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 
Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 
Novartis Pharma B.V. 

Tel: +31 26 37 82 555 



 

132 

Eesti 

Novartis Pharma Services Inc. 

Tel: +372 66 30 810 

 

Norge 
Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 
Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 
Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 
Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 
 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 
Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 
Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 
Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 
Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA “Novartis Baltics” 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

This leaflet was last revised in 

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency website: 

http://www.ema.europa.eu 

http://www.ema.europa.eu/


 

133 

Package leaflet: Information for the user 

 

EXJADE 90 mg granules in sachet 

EXJADE 180 mg granules in sachet 

EXJADE 360 mg granules in sachet 

Deferasirox 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 
 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed only for you or your child. Do not pass it on to others. It may 

harm them, even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 
1. What EXJADE is and what it is used for 

2. What you need to know before you take EXJADE 

3. How to take EXJADE 

4. Possible side effects 

5. How to store EXJADE 

6. Contents of the pack and other information 

 

 

1. What EXJADE is and what it is used for 
 

What EXJADE is 

EXJADE contains an active substance called deferasirox. It is an iron chelator which is a medicine 

used to remove the excess iron from the body (also called iron overload). It traps and removes excess 

iron which is then excreted mainly in the stools. 

 

What EXJADE is used for 

Repeated blood transfusions may be necessary in patients with various types of anaemia (for example 

thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)). However, repeated blood 

transfusions can cause a build-up of excess iron. This is because blood contains iron and your body 

does not have a natural way to remove the excess iron you get with your blood transfusions. In 

patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over 

time, mainly due to increased absorption of dietary iron in response to low blood cell counts. Over 

time, the excess iron can damage important organs such as the liver and heart. Medicines called iron 

chelators are used to remove the excess iron and reduce the risk of it causing organ damage. 

 

EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with 

beta thalassaemia major aged 6 years and older. 

 

EXJADE is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or 

inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood 

transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years. 

 

EXJADE is also used when deferoxamine therapy is contraindicated or inadequate to treat patients 

aged 10 years or older who have iron overload associated with their thalassaemia syndromes, but who 

are not transfusion dependent. 

 



 

134 

 

2. What you need to know before you take EXJADE 
 

Do not take EXJADE 
- if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in 

section 6). If this applies to you, tell your doctor before taking EXJADE. If you think you 

may be allergic, ask your doctor for advice. 

- if you have moderate or severe kidney disease. 
- if you are currently taking any other iron chelator medicines. 
 

EXJADE is not recommended 

- if you are at an advanced stage of myelodysplastic syndrome (MDS; decreased production of 
blood cells by the bone marrow) or have advanced cancer. 

 

Warnings and precautions 

Talk to your doctor or pharmacist before taking EXJADE: 

- if you have a kidney or liver problem. 

- if you have a cardiac problem due to iron overload. 

- if you notice a marked decrease in your urine output (sign of kidney problem). 

- if you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face 

and throat (signs of severe allergic reaction, see also section 4 “Possible side effects”). 

- if you experience a combination of any of the following symptoms: rash, red skin, blistering of 

the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes 

(signs of severe skin reaction, see also section 4 “Possible side effects”). 

- if you experience a combination of drowsiness, upper right abdominal pain, yellowing or 

increased yellowing of your skin or eyes and dark urine (signs of liver problems). 

- if you experience difficulty thinking, remembering information, or solving problems, being less 

alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your 

blood, which may be associated with liver or renal problems, see also section 4 “Possible side 

effects”). 

- if you vomit blood and/or have black stools. 

- if you experience frequent abdominal pain, particularly after eating or taking EXJADE. 

- if you experience frequent heartburn. 

- if you have a low level of platelets or white blood cells in your blood test. 

- if you have blurred vision 

- if you have diarrhoea or vomiting. 

If any of these apply to you, tell your doctor straight away. 

 

Monitoring your EXJADE treatment 

You will have regular blood and urine tests during treatment. These will monitor the amount of iron in 

your body (blood level of ferritin) to see how well EXJADE is working. The tests will also monitor 

your kidney function (blood level of creatinine, presence of protein in the urine) and liver function 

(blood level of transaminases). Your doctor may require you to undergo a kidney biopsy, if he/she 

suspects significant kidney damage. You may also have MRI (magnetic resonance imaging) tests to 

determine the amount of iron in your liver. Your doctor will take these tests into consideration when 

deciding on the dose of EXJADE most suitable for you and will also use these tests to decide when 

you should stop taking EXJADE. 

 

Your eyesight and hearing will be tested each year during treatment as a precautionary measure. 

 

  



 

135 

Other medicines and EXJADE 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. This includes in particular: 

- other iron chelators, which must not be taken with EXJADE, 

- antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at 

the same time of day as EXJADE, 

- ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such 

as rheumatoid arthritis or atopic dermatitis), 

- simvastatin (used to lower cholesterol), 

- certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids), 

- oral bisphosphonates (used to treat osteoporosis), 

- anticoagulant medicines (used to prevent or treat blood clotting), 

- hormonal contraceptive agents (birth control medicines), 

- bepridil, ergotamine (used for heart problems and migraines), 

- repaglinide (used to treat diabetes), 

- rifampicin (used to treat tuberculosis), 

- phenytoin, phenobarbital, carbamazepine (used to treat epilepsy), 

- ritonavir (used in the treatment of HIV infection), 

- paclitaxel (used in cancer treatment), 

- theophylline (used to treat respiratory diseases such as asthma), 

- clozapine (used to treat psychiatric disorders such as schizophrenia), 

- tizanidine (used as a muscle relaxant), 

- cholestyramine (used to lower cholesterol levels in the blood), 

- busulfan (used as a treatment prior to transplantation in order to destroy the original bone 

marrow before the transplant). 

 

Additional tests may be required to monitor the blood levels of some of these medicines. 

 

Older people (age 65 years and over) 
EXJADE can be used by people aged 65 years and over at the same dose as for other adults. Elderly 

patients may experience more side effects (in particular diarrhoea) than younger patients. They should 

be monitored closely by their doctor for side effects that may require a dose adjustment. 

 

Children and adolescents 

EXJADE can be used in children and adolescents receiving regular blood transfusions aged 2 years 

and over and in children and adolescents not receiving regular blood transfusions aged 10 years and 

over. As the patient grows the doctor will adjust the dose. 

 

EXJADE is not recommended for children aged under 2 years. 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor for advice before taking this medicine. 

 

EXJADE is not recommended during pregnancy unless clearly necessary. 

 

If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, 

you should use an additional or different type of contraception (e.g. condom), as EXJADE may reduce 

the effectiveness of oral and patch contraceptives. 

 

Breast-feeding is not recommended during treatment with EXJADE. 

 

Driving and using machines 
If you feel dizzy after taking EXJADE, do not drive or operate any tools or machines until you are 

feeling normal again. 

 

 



 

136 

3. How to take EXJADE 
 

Treatment with EXJADE will be overseen by a doctor who is experienced in the treatment of iron 

overload caused by blood transfusions. 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 

if you are not sure. 

 

How much EXJADE to take 

The dose of EXJADE is related to body weight for all patients. Your doctor will calculate the dose you 

need and tell you how many sachets to take each day. 

 The usual daily dose for EXJADE granules at the start of the treatment for patients receiving 
regular blood transfusions is 14 mg per kilogram body weight. A higher or lower starting dose 

may be recommended by your doctor based on your individual treatment needs. 

 The usual daily dose for EXJADE granules at the start of the treatment for patients not receiving 

regular blood transfusions is 7 mg per kilogram body weight. 

 Depending on how you respond to treatment, your doctor may later adjust your treatment to a 
higher or lower dose. 

 The maximum recommended daily dose for EXJADE granules: 

 28 mg per kilogram body weight for patients receiving regular blood transfusions, 

 14 mg per kilogram body weight for adult patients not receiving regular blood 
transfusions, 

 7 mg per kilogram body weight for children and adolescents not receiving regular blood 
transfusions. 

 

Deferasirox also comes as “dispersible” tablets. If you are switching from the dispersible tablets to 

these granules, you will need an adjustment of the dose. 

 

When to take EXJADE 

 Take EXJADE once a day, every day, at about the same time each day. 

 Take EXJADE granules either with or without a light meal. 
Taking EXJADE at the same time each day will also help you remember when to take your medicine. 

 

EXJADE granules should be taken by sprinkling the full dose onto soft food such as yogurt or apple 

sauce (pureed apple). The food should be immediately and completely consumed. Do not store it for 

future use. 

 

How long to take EXJADE 

Continue taking EXJADE every day for as long as your doctor tells you. This is a long-term 

treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to 

check that the treatment is having the desired effect (see also section 2: “Monitoring your EXJADE 

treatment”). 

 

If you have questions about how long to take EXJADE, talk to your doctor. 

 

If you take more EXJADE than you should 
If you have taken too much EXJADE, or if someone else accidentally takes your granules, contact 

your doctor or hospital for advice straight away. Show the doctor the pack of granules. Urgent medical 

treatment may be necessary. You may experience effects such as abdominal pain, diarrhoea, nausea 

and vomiting and kidney or liver problems that can be serious. 

 

If you forget to take EXJADE 
If you miss a dose, take it as soon as you remember on that day. Take your next dose as scheduled. Do 

not take a double dose on the next day to make up for the forgotten granules. 

 



 

137 

If you stop taking EXJADE 
Do not stop taking EXJADE unless your doctor tells you to. If you stop taking it, the excess iron will 

no longer be removed from your body (see also above section “How long to take EXJADE”). 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of 

the side effects are mild to moderate and will generally disappear after a few days to a few weeks of 

treatment. 

 

Some side effects could be serious and need immediate medical attention. 

These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 

1,000 people). 

 If you get a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and 
throat (signs of severe allergic reaction), 

 If you experience a combination of any of the following symptoms: rash, red skin, blistering of 
the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes, 

(signs of severe skin reactions), 

 If you notice a marked decrease in your urine output (sign of kidney problem), 

 If you experience a combination of drowsiness, upper right abdominal pain, yellowing or 
increased yellowing of your skin or eyes and dark urine (signs of liver problems), 

 If you experience difficulty thinking, remembering information, or solving problems, being less 
alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your 

blood, which may be associated with liver or renal problems and lead to a change in your brain 

function), 

 If you vomit blood and/or have black stools, 

 If you experience frequent abdominal pain, particularly after eating or taking EXJADE, 

 If you experience frequent heartburn, 

 If you experience partial loss of vision, 

 If you experience severe upper stomach pain (pancreatitis), 
stop taking this medicine and tell your doctor straight away. 

 

Some side effects could become serious. 

These side effects are uncommon. 

 If you get blurred or cloudy eyesight, 

 If you get reduced hearing, 
tell your doctor as soon as possible. 

 

Other side effects 

Very common (may affect more than 1 in 10 people) 

 Disturbance in kidney function tests. 
 

Common (may affect up to 1 in 10 people) 

 Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating, 
constipation, indigestion 

 Rash 

 Headache 

 Disturbance in liver function tests 

 Itching 

 Disturbance in urine test (protein in the urine) 
If any of these affects you severely, tell your doctor. 

 

  



 

138 

Uncommon (may affect up to 1 in 100 people) 

 Dizziness 

 Fever 

 Sore throat 

 Swelling of arms or legs 

 Change in the colour of the skin 

 Anxiety 

 Sleep disorder 

 Tiredness 
If any of these affects you severely, tell your doctor. 

 

Frequency not known (cannot be estimated from the available data). 

 A decrease in the number of cells involved in blood clotting (thrombocytopenia), in the number 
of red blood cells (anaemia aggravated), in the number of white blood cells (neutropenia) or in 

the number of all kinds of blood cells (pancytopenia) 

 Hair loss 

 Kidney stones 

 Low urine output 

 Tear in stomach or intestine wall that can be painful and cause nausea 

 Severe upper stomach pain (pancreatitis) 

 Abnormal level of acid in blood 
 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

5. How to store EXJADE 
 

 Keep this medicine out of the sight and reach of children. 

 Do not use this medicine after the expiry date which is stated on the sachet and the carton after 
EXP. The expiry date refers to the last day of that month. 

 Do not use any pack that is damaged or shows signs of tampering. 

 Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 
how to throw away medicines you no longer use. These measures will help protect the 

environment. 

 

 

6. Contents of the pack and other information 

 

What EXJADE contains 

The active substance is deferasirox. 

 Each sachet of EXJADE 90 mg granules contains 90 mg deferasirox. 

 Each sachet of EXJADE 180 mg granules contains 180 mg deferasirox. 

 Each sachet of EXJADE 360 mg granules contains 360 mg deferasirox. 
The other ingredients are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; 

colloidal anhydrous silica and poloxamer. 

 

What EXJADE looks like and contents of the pack 

EXJADE granules are supplied as white to almost white granules in sachets. 

 

Each pack contains 30 sachets. 

 

Not all strengths may be available in your country. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

139 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Pharma GmbH 

Roonstraße 25 

D-90429 Nuremberg 

Germany 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België/Belgique/Belgien 
Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 
Novartis Pharma Services Inc. 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 
Novartis Pharma N.V 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 
Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 
Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 
Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 
Novartis Pharma B.V. 

Tel: +31 26 37 82 555 

Eesti 

Novartis Pharma Services Inc. 

Tel: +372 66 30 810 

 

Norge 
Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 
Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 
Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 
Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 
 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 



 

140 

Ireland 
Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 
Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 
Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 
Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA “Novartis Baltics” 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

This leaflet was last revised in 

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency website: 

http://www.ema.europa.eu 

 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET