Fasturtec

Posology Fasturtec is to be used immediately prior to and during the initiation of chemotherapy only, as at the present, there is insufficient data to recommend multiple treatment courses. 20 mg/kg/day. 6). The duration of treatment with Fasturtec may be up to 7 days, the exact duration should be based upon adequate monitoring of uric acid levels in plasma and clinical judgment.

20 mg/kg/day. 3 Special populations Renally or hepatically impaired patients: No dose adjustment is necessary. Method of Administration Fasturtec should be administered under the supervision of a physician trained in chemotherapy of haematological malignancies.

Administration of rasburicase does not require any change in the timing or schedule of initiation of cytoreductive chemotherapy. Rasburicase solution should be infused over 30 minutes. Rasburicase solution should be infused through a different line than that used for infusion of chemotherapeutic agents to prevent any possible drug incompatibility.

If use of a separate line is not possible, the line should be flushed out with saline solution between infusion of chemotherapeutic agents and rasburicase. 6. 6.

Summary of the safety profile Fasturtec is concomitantly administered as supportive care to cytoreductive chemotherapy of advanced malignancies, the causality 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 commonly reported adverse reactions were nausea, vomiting, headache, fever, and diarrhoea. In clinical trials, haematological disorders such as 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 such as those with G6PD deficiency. Adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed below, by system organ class and by frequency.

Frequencies are defined using the following MedDRA convention as: 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 5 available data).

Tabulated list of adverse reactions MedDRA Organ system classes Very common Common Uncommon Rare Not known Blood and lymphatic system disorders - Haemolysis - Haemolytic anaemia - Methaemoglobin aemia Immune system disorders - Allergy/ allergic reactions (rashes and urticaria) - Severe hypersensitivity reactions - Anaphylaxis - Anaphylactic shock* Nervous system disorders - Headache + - Convulsion** - Muscle contraction involuntary** Vascular disorders - Hypotension Respiratory, thoracic and mediastinal disorders - Bronchospasm - Rhinitis Gastrointestina l disorders - Diarrhoea + - Vomiting++ - Nausea++ General disorders and administration site conditions - Fever++ * Anaphylactic shock including potential fatal outcome ** From post-marketing experience + Uncommon G3/4 ++ Common G3/4 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Rasburicase like other proteins, has the potential to induce allergic responses in humans, such as anaphylaxis, including anaphylactic shock, with potential fatal outcome. 8). In case of severe allergic reaction, treatment should immediately and permanently be discontinued and appropriate therapy initiated.

Caution should be used in patients with a history of atopic allergies. At present, there is insufficient data available on patients being retreated to recommend multiple treatment courses. Anti-rasburicase antibodies have been detected in treated patients and healthy volunteers administered rasburicase.

Methaemoglobinaemia has been reported in patients receiving Fasturtec. 8). Haemolysis has been reported in patients receiving Fasturtec. 8). Administration of Fasturtec reduces the uric acid levels to below normal levels and by this mechanism reduces the chance of development of renal failure due to precipitation of uric acid crystals in renal tubules as a consequence of hyperuricaemia.

Tumour lysis can also result in hyperphosphataemia, hyperkalaemia and hypocalcaemia. Fasturtec is not directly effective in the treatment of these abnormalities. Therefore, patients must be monitored closely. Fasturtec has not been investigated in the patients with hyperuricemia in the context of myeloproliferative disorders.

6). 53 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

1. G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia. Hydrogen peroxide is a by-product of the conversion of uric acid to allantoin. In order to prevent possible haemolytic anaemia induced by hydrogen peroxide, rasburicase is contraindicated in patients with these disorders.