For Healthcare Professionals Outside the US

In patients with transfusional iron overload

 
FEWER SEVERE AdversE eventS THAN EXJADE DT
AE, adverse events; DT, dispersible tablets; FCT, film-coated tablets; GI, gastrointestinal; UPCR, urine protein/creatinine ratio.
 
DEFERASIROX SAFETY PROFILE
Most common (>3) Drug-related adverse events3
Based on clinical trial results with deferasirox dispersible tablets for oral suspension.
Adverse event Thalassemia
(n=1115)
No. (%)
SCD
(n=80)
No. (%)
Lower-risk MDS
(n=341)
No. (%)
Skin rash 129 (11.5) 3 (3.7) 23 (6.7)
Diarrhea 87 (7.8) 9 (11.3) 111 (32.6)
Abdominal pain 54 (4.8) 1 (1.3) 26 (7.6)
Nausea 42 (3.8) 5 (6.3) 45 (13.2)
Upper abdominal pain 25 (2.2) 5 (6.3) 25 (7.3)
Vomiting 20 (1.8) 3 (3.7) 26 (7.6)

MDS, myelodysplastic syndromes; SCD, sickle cell disease.

The safety profile is based on clinical trials conducted with EXJADE® (deferasirox) dispersible tablets for oral suspension and the product postmarketing experience. Postmarketing reports of adverse reactions in patients on deferasirox include acute renal failure, hepatic failure, gastrointestinal perforation, metabolic acidosis, severe hypersensitivity reactions, severe skin reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis ) and aggravated cytopenia. Many of the patients had comorbidities or preexisting conditions. These adverse reactions 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.1 Please see full Product Information for greater detail. EXJADE® (deferasirox) film-coated tablets was evaluated in healthy subjects.1 Currently, there are limited data in patients with EXJADE film-coated tablets.4

Most frequent adverse events were generally mild to moderate1

  • These adverse events were dose-dependent and could be managed without discontinuation

Click here for Important Safety Information.

To report a suspected side effect related to EXJADE film-coated tablets, please click here.

 
MONITORING

EXJADE film-coated tablets requires regular monitoring1

  • Adverse reactions occurred more frequently in elderly patients

Recommended monitoring during treatment1

  • After starting EXJADE film-coated tablets and throughout treatment: patients should be tested on a regular basis. Please see full Product Information for greater detail

 

 

Baseline

In the first month

after initiation of EXJADE film-coated tablets or after dose modification

Monthly

Every 3 months

  Yearly  

Serum ferritin        
Liver iron concentration        

(for pediatric patients only, if SF is ≤800 μg/L)

 
Serum creatinine

2x

Weekly

(Should also be tested weekly in the first month after dose modification)

     
Creatinine clearance and/or plasma cystatin C  

Weekly

(Should also be tested weekly in the first month after dose modification)

     
Proteinuria          
Serum transaminases, bilirubin, alkaline phosphatase  

Every 2 weeks

     
Body weight and height          

In pediatric patients

Auditory/ophthalmic testing (including fundoscopy)          
Sexual development
(pediatric patients)
         

SF, serum ferritin.

 
SAFETY IN PEDIATRIC AND ADULT PATIENTS

Normal long-term growth and sexual development1,5,6

  • Physical and sexual development remained normal in pediatric patients with thalassemia or sickle cell disease over 5 years

Children from birth to 23 months1

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

No additional adverse events after dose escalation7

  • At EXJADE dispersible tablets for oral suspension doses of >30 mg/kg/day (doses equivalent to EXJADE film-coated tablets >21 mg/kg/day), no drug-related adverse events were observed that had not been previously observed at lower doses
  • Serum creatinine levels remained consistent at higher doses of EXJADE dispersible tablets for oral suspension
    (37.5 mg/kg/day) (equivalent doses of EXJADE film-coated tablets, 26.3 mg/kg/day)

Adherence

References

Please note: In some countries, EXJADE film-coated tablets is available as JADENU® (deferasirox) tablets.