FASTURTEC Powder and solvent for concentrate for solution for infusion (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.

Qualitative and quantitative composition

Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae strain. Rasburicase is a tetrameric protein with identical subunits of a molecular mass ...

Pharmaceutical form

Powder and solvent for concentrate for solution for infusion (powder for sterile concentrate). The powder is an entire or broken white to off white pellet. The solvent is a colourless and clear liquid. ...

Therapeutic indications

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 ...

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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia. Hydrogen peroxide is ...

Special warnings and precautions for use

Rasburicase like other proteins, has the potential to induce allergic responses in humans, such as anaphylaxis, including anaphylactic shock, with potential fatal outcome. Clinical experience with Fasturtec ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. Rasburicase being an enzyme itself, it would be an unlikely candidate for drug-drug interactions.

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of rasburicase in pregnant women. Results from animal studies could not be interpreted due to the presence of endogenous urate oxidase in standard animal models. ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

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 ...

Overdose

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment ATC code: V03AF07 Mechanism of action In humans, uric acid is the final step in the catabolic pathway of purines. The acute increase ...

Pharmacokinetic properties

The pharmacokinetics of rasburicase were evaluated in both paediatric and adult patients with leukaemia, lymphoma or other haematological malignancies. Absorption After infusion of rasburicase at a dose ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. The interpretation of the non-clinical studies is hampered ...

List of excipients

Powder: Alanine Mannitol Disodium phosphate dodecahydrate Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Solvent: Poloxamer 188 Water for injection

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Rasburicase solution should be infused through a different line than that used for infusion ...

Shelf life

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.

Special precautions for storage

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 ...

Nature and contents of container

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 ...

Special precautions for disposal and other handling

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 ...

Marketing authorization holder

Sanofi-aventis groupe, 54, rue La Boétie, F-75008 Paris, France

Marketing authorization number(s)

EU/1/00/170/001-002

Date of first authorization / renewal of the authorization

Date of first authorisation: 23 February 2001 Date of latest renewal: 9 February 2006

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