Fasturtec is concomitantly administered as supportive care to cytoreductive chemotherapy of advanced malignancies, the casuality of adverse events is therefore difficult to assess due to the significant burden of adverse events expected from the underlying disease and its treatment.
The most significant drug-related adverse events were allergic reactions, mainly rashes and urticaria. Cases of hypotension (<1%), bronchospasm (<1%), rhinitis (<0.1%) and severe hypersensitivity reactions (<1%), including anaphylaxis (<0.1%) have also been attributed to Fasturtec.
In clinical trials, haematological disorders eg, haemolysis, haemolytic anaemia and methaemoglobinaemia are uncommonly caused by Fasturtec. The enzymatic digestion of uric acid to allantoin by rasburicase produces hydrogen peroxide and haemolytic anaemia or methaemoglobinaemia have been observed in certain at risk populations eg, those with G6PD deficiency.
In addition, grade 3 or 4 adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed as follows by system organ class and by frequency. Frequencies are defined using the following MedDRA convention as: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000).
Nervous System Disorders: Uncommon: Headache.
Gastrointestinal Disorders: Uncommon: Diarrhea, vomiting, nausea.
General Disorders and Administration Site Conditions: Common: Fever.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.