FASTURTEC POWDER FOR SOLUTION FOR INFUSION 1.5 MG/VIAL [SIN12055P]

Product Info

FASTURTEC POWDER FOR SOLUTION FOR INFUSION 1.5 MG/VIAL

[SIN12055P]

Therapeutic Indications
Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in patients with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.

Posology and Method of Administration
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.

The recommended dose for Fasturtec is 0.20 mg/kg/day. Fasturtec is administered as a once daily 30 minute intravenous infusion in 50 ml of a sodium chloride 9 mg/ml (0.9%) solution (see section Special Precautions for Disposal and Other Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

Paediatric Population
As no adjustment is necessary, the recommended dose is 0.20 mg/kg/day.

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. For instructions on reconstitution and dilution of the medicinal product before administration, see section Special Precautions for Disposal and Other Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Because rasburicase may degrade uric acid in vitro, special precautions must be used during sample handling for plasma uric acid measurements, see section Special Precautions for Disposal and Other Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications
Hypersensitivity to the active substance, to uricases, or to any of the excipients listed in section List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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.