Table 2.

Exclusion criteria and interruption of therapy at the beginning and during the course of treatment.

• Pregnancy or breast-feeding

• Progressive or persistent increase in the creatinine level:

• Any cardiac, auditory or ophthalmic problem

• HCV, HBV or HIV infections

• Persistent liver transaminases above 5-fold of the normal level:

• Repeated unexplained cytopenia *(neutropenia<1500/ml and thrombocytopenia<150000) and, unexplained agranulocytosis <500/ml,

• Severe nausea and vomiting (not controlled within 24 hours diagnosed by physician)

• Hypersensitivity to deferasirox

• Occurrence of any sever adverse effects regardless of being drug related or not,diagnosed by physician

• Sever skin rashes (not controlled by corticosteroids diagnosed by physician)

•  or progressive proteinuria

• Non-compliant or unreliable patients

• Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug.

• Falling serum ferritin consistently below 500 µg/l, consideration should be given to temporarily interruption therapy

• if serum ferritin increasing in 30% of baseline level and persists for 3 months despite of proper dose scaling Osveral® should be interrupted