Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Sanofi-aventis groupe, 54, rue La Boétie, F-75008 Paris, France
Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
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 6.6).
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.
As no adjustment is necessary, the recommended dose is 0.20 mg/kg/day.
No dose adjustment is necessary.
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 6.6.
Because rasburicase may degrade uric acid in vitro, special precautions must be used during sample handling for plasma uric acid measurements, see section 6.6.
In view of the mechanism of action of Fasturtec, an overdose will lead to low or undetectable plasma uric acid concentrations and increased production of hydrogen peroxide. Thus patients suspected of receiving an overdose should be monitored for haemolysis, and general supportive measures should be initiated as no specific antidote for Fasturtec has been identified.
3 years.
After reconstitution or dilution an immediate use is recommended. However, the in-use stability has been demonstrated for 24 hours between +2°C and 8°C.
Powder in vial: store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Fasturtec is supplied as a pack of:
3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent. The powder is supplied in 3 ml clear glass (type I) vial with a rubber stopper and the solvent in a 2 ml clear glass (type I) ampoule.
1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent. The powder is supplied in 10 ml clear glass (type I) vial with a rubber stopper and the solvent in a 5 ml clear glass (type I) ampoule.
Not all pack sizes may be marketed.
Rasburicase must be reconstituted with the entire volume of the supplied solvent ampoule (1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule). Reconstitution results in a solution with a concentration of 1.5 mg/ml rasburicase to be further diluted with sodium chloride 9 mg/ml (0.9%) intravenous solution.
Reconstitution of the solution:
Add the content of one ampoule of solvent to one vial containing rasburicase and mix by swirling very gently under controlled and validated aseptic conditions.
Do not shake.
Inspect visually prior to use. Only clear and colourless solutions without particles should be used.
For single-use only, any unused solution should be discarded.
The solvent contains no preservative. Therefore the reconstituted solution should be diluted under controlled and validated aseptic conditions.
Dilution before infusion:
The required volume of the reconstituted solution depends on the patient’s body weight. The use of several vials may be necessary to obtain the quantity of rasburicase required for one administration.
The required volume of the reconstituted solution, taken from one or more vials, is to be further diluted with sodium chloride 9 mg/ml (0.9%) solution to make a total volume of 50 ml. The concentration of rasburicase in the final solution for infusion depends on the patient’s body weight.
The reconstituted solution contains no preservative. Therefore the diluted solution should be infused immediately.
Infusion:
The final solution should be infused over 30 minutes.
Sample handling:
If it is necessary to monitor a patient’s uric acid level, a strict sample-handling procedure must be followed to minimise ex vivo degradation of the analyte. Blood must be collected into pre-chilled tubes containing heparin anticoagulant. Samples must be immersed in an ice/water bath. Plasma samples should immediately be prepared by centrifugation in a pre-cooled centrifuge (4°C). Finally, plasma must be maintained in an ice/water bath and analysed for uric acid within 4 hours.
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