Ferasiro Adverse Reactions

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.
Dose-dependent increases in serum creatinine occurred in 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 Precautions).
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 FERASIRO (see Precautions).
Tabulated list of adverse reactions: Adverse reactions are ranked as follows using the following convention: very common; common; uncommon; rare; very rare; not known. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 6.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Gallstones and related biliary disorders were reported in patients. Elevations of liver transaminases were reported as an adverse reaction. Elevations of transaminases greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon.
During post-marketing experience, hepatic failure, sometimes fatal, has been reported with deferasirox (see Precautions). 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 Precautions). 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 Precautions).
Creatinine clearance in transfusional iron overload: A mean creatinine clearance decrease in adult patients and in paediatric patients was observed during the first year of treatment. For up to five years, no further decrease in mean creatinine clearance levels was observed.
Patients with non-transfusion-dependent thalassaemia syndromes: In patients with non-transfusion-dependent thalassaemia syndromes and iron overload (dispersible tablets at a dose of 10 mg/kg/day), diarrhoea, rash, and nausea were the most frequent drug-related adverse events. Abnormal serum creatinine and creatinine clearance values were reported. Elevations of liver transaminases greater than 2 times the baseline and 5 times the upper limit of normal were reported in patients.
Paediatric population: Growth and sexual development of paediatric patients treated with deferasirox for up to 5 years were not affected (see Precautions).
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.