Fasturtec

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 



2 

1. NAME OF THE MEDICINAL PRODUCT 

 

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

 

 

2. 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 of 

about 34 kDa. 

 

After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg rasburicase. 

 

1 mg corresponds to 18.2 EAU*. 

 

*One enzyme activity unit (EAU) corresponds to the enzyme activity that converts 1 µmol of uric acid 

into allantoin per minute under the operating conditions described: +30 °C ± 1 °C TEA pH 8.9 buffer. 

 

For the full list of excipients, see section 6.1. 

 

 

3. 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. 

 

 

4. CLINICAL PARTICULARS 

 

4.1. 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 and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy. 

 

4.2. 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 

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. 

 

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. 

 



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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 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. 

 

4.3 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 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. 

 

4.4 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 demonstrates that patients should be closely monitored for the onset of allergic-type 

undesirable effects, especially severe hypersensitivity reactions including anaphylaxis (see section 

4.8). 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. Fasturtec should immediately 

and permanently be discontinued in patients having developed methaemoglobinaemia, and appropriate 

measures initiated (see section 4.8). 

 

Haemolysis has been reported in patients receiving Fasturtec. In such case, treatment should 

immediately and permanently be discontinued and appropriate measures initiated (see section 4.8). 

 

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. 

 

To ensure accurate measurement of uric acid plasma level during treatment with Fasturtec, a strict 

sample handling procedure must be followed (see section 6.6). 

 



4 

4.5 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. 

 

4.6 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. 

Because teratogenic effects of rasburicase cannot be ruled out, Fasturtec should only be used during 

pregnancy if strictly necessary.  Fasturtec is not recommended in women of childbearing potential not 

using contraception. 

 

Breast-feeding 

It is unknown whether rasburicase is excreted in human milk. As a protein the dose for the infant is 

expected to be very low. During treatment with Fasturtec, the advantage of breastfeeding should be 

weighted against the potential risk for the infant. 

 

Fertility 

There are no data regarding the effect of rasburicase on fertility. 

 

4.7 Effects on ability to drive and use machines 

 

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

 

4.8 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 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 diarrhea. 

 

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 

available data). 

 



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Tabulated list of adverse reactions 

 

MedDRA 

Organ system 

classes 

Very 

common 

 

Common 

 

Uncommon 

 

Rare Not known 

Blood and 

lymphatic 

system 

disorders 

 

  - Haemolysis 

- Haemolytic 

anaemia  

- 

Methaemoglobina

emia 

  

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 
 

 

Gastrointestinal 

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. 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 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 an overdose should be monitored for haemolysis, and general supportive measures should be 

initiated as no specific antidote for Fasturtec has been identified. 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


6 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 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 in plasma 

levels of uric acid subsequent to the lysis of large numbers of malignant cells and during cytoreductive 

chemotherapy may lead to impairment of renal function and renal failure resulting from the 

precipitation of crystals of uric acid in renal tubules. Rasburicase is a highly potent uricolytic agent 

that catalyses enzymatic oxidation of uric acid into allantoin, a water soluble product, easily excreted 

by the kidneys in the urine. 

The enzymatic oxidation of uric acid leads to stoichiometric formation of hydrogen peroxide. The 

increased of hydrogen peroxide over ambient levels can be eliminated by endogenous antioxidants and 

the only increased risk is for haemolysis in G6PD deficient and inherited anaemia patients. 

 

In healthy volunteers, a marked dose-related decrease in plasma uric acid levels was observed across 

the dose range 0.05 mg/kg to 0.20 mg/kg of Fasturtec. 

 

Clinical efficacy and safety 

In a randomised comparative phase III study, performed in 52 paediatric patients, 27 patients were 

treated with rasburicase at the recommended dose of 0.20 mg/kg/day, intravenously, for 4 to 7 days 

(< 5 years: n=11; 6-12 years: n=11; 13-17 years: n=5), and 25 patients with allopurinol daily oral 

doses for 4 to 8 days. Results showed a significantly more rapid onset of action of Fasturtec in 

comparison with allopurinol. At 4 hours post first dose, there was a significant difference in the mean 

percentage change from baseline plasma uric acid concentration (p <0.0001) in the Fasturtec group (-

86.0%) compared to that for the allopurinol group (-12.1%). 

 

Time to first confirmation of normal levels of uric acid in hyperuricaemic patients is four hours for 

Fasturtec and 24 hours for allopurinol. In addition this rapid control of uric acid in this population is 

accompanied by improvements in renal function. In turn, this allows efficient excretion of the serum 

phosphate load preventing further deterioration of renal function from calcium/phosphorus 

precipitation. 

 

In a randomized (1:1:1), multi-center, open-label study, 275 adult patients with leukemia and 

lymphoma at risk for hyperuricemia and tumour lysis syndrome (TLS) were treated with either 

rasburicase at a dose of 0.2 mg/kg/day, intravenously, for 5 days (arm A: n=92), rasburicase at a dose 

of 0.2 mg/kg/day, intravenously, from day 1 through day 3 followed by oral allopurinol at a dose of 

300 mg once a day from day 3 through day 5 (overlap on day 3: rasburicase and allopurinol 

administered approximately 12 hours apart) (arm B: n=92), or oral allopurinol at a dose of 300 mg 

once a day for 5 days (arm C: n=91). The uric acid response rate (proportion of patients with plasma 

uric acid levels ≤7.5 mg/dl from day 3 to day 7 after initiation of antihyperuricemic treatment) was 

87% in arm A, 78% in arm B, and 66% in arm C. The response rate in arm A was significantly greater 

than in arm C (p=0.0009); the response rate was higher for arm B compared to arm C although this 

difference was not statistically significant. Uric acid levels were <2 mg/dl in 96% of patients in the 

two arms containing rasburicase and 5% of patients in the allopurinol arm at 4 hours of the day 1 dose. 

The safety results of patients treated with Fasturtec in Study EFC4978 were consistent with the 

adverse events profile observed in previous clinical studies with predominantly paediatric patients. 

 

In pivotal clinical studies, 246 paediatric patients ( mean age 7 years, range 0 to17) were treated with 

rasburicase at doses of 0.15 mg/kg/day or 0.20 mg/kg/day for 1 to 8 days (mainly 5 to 7 days). 

Efficacy results on 229 evaluable patients showed an overall response rate (normalization of plasma 

uric acid levels) of 96.1%. Safety results on 246 patients were consistent with the adverse events 

profile in the overall population. 

In long term safety studies, an analysis of data from 867 paediatric patients (mean age 7.3 years, range 

0 to17) treated with rasburicase at 0.20 mg/kg/day for 1 to 24 days (mainly 1 to 4 days) showed 



7 

consistent findings with pivotal clinical studies in terms of efficacy and safety. 

 

5.2 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 of 0.20 mg/kg/day, steady state is achieved at day 2 - 3. 

Minimal accumulation of rasburicase (<1.3 fold) was observed between days 1 and 5 of dosing. 

 

Distribution 

The mean volume of distribution ranged from 110 - 127 ml/kg in paediatric patients and from 75.8 to 

138 ml/kg in adult patients, respectively, which is comparable to the physiological vascular volume. 

 

Metabolism 

Rasburicase is a protein, and therefore: 1) not expected to bind to proteins, 2) expected that metabolic 

degradation will follow the pathways of other proteins, i.e. peptide hydrolysis, 3) unlikely to be 

candidate for drug-drug interactions.  

 

Elimination  

Clearance of rasburicase was ca. 3.5 ml/h/kg. The mean terminal half-life was similar between 

paediatric and adult patients and ranged from 15.7 to 22.5 hours. Clearance is increased (ca. 35%) in 

children and adolescents compared to adults, resulting in a lower systemic exposure. Renal elimination 

of rasburicase is considered to be a minor pathway for rasburicase clearance. 

 

Special patient populations  

In adults (≥ the age of 18 years), age, gender, baseline liver enzymes and creatinine clearance did not 

impact the pharmacokinetics of rasburicase. A cross-study comparison revealed that after 

administration of rasburicase at 0.15 or 0.20 mg/kg, the geometric mean values of body-weight 

normalized clearance were approximately 40% lower in Japanese (n=20) than that in Caucasians 

(n=26).  

 

As metabolism is expected to occur by peptide hydrolysis, an impaired liver function is not expected 

to affect the pharmacokinetics. 

 

5.3 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 due to the presence of endogenous urate oxidase in standard animal models. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Powder: 

alanine 

mannitol 

disodium phosphate dodecahydrate 

disodium phosphate dihydrate 

sodium dihydrogen phosphate dihydrate 

 

Solvent: 

poloxamer 188 

water for injection 



8 

 

6.2 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 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 chemotherapeutic agent infusions 

and rasburicase. 

No filter should be used for infusion. 

Do not use any glucose solution for dilution due to potential incompatibility. 

 

6.3 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. 

 

6.4 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 product, see section 6.3. 

 

6.5 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 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. 

 

6.6 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 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. 

 



9 

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. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

sanofi-aventis groupe 

54, rue La Boétie 

F - 75008 Paris 

France 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/00/170/001-002 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 23 February 2001 

Date of latest renewal: 23 February 2006 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this product is available on the website of the European Medicines Agency 

http://www.ema.europa.eu 



10 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 

SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE 

FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 



11 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 

MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer(s) of the biological active substance(s) 

 

Sanofi Chimie 

Route d’Avignon 

30390 Aramon 

France 

 

Name and address of the manufacturer(s) responsible for batch release 

 

Sanofi S.p.A.  

Via Valcanello, 4 

03012 Anagni (FR) 

Italy 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

Not applicable. 

  



12 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

 



13 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



14 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PACK OF 3 POWDER VIALS and 3 SOLVENT AMPOULES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

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

 

rasburicase 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

rasburicase 1.5 mg/1 ml 

 

rasburicase produced by genetechnology in Saccharomyces cerevisiae strain 

 

 

3. LIST OF EXCIPIENTS 

 

Powder also contains: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate 

dihydrate, sodium dihydrogen phosphate dihydrate. 

 

Solvent: poloxamer 188, water for injection. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Powder and solvent for concentrate for solution for infusion 

 

3 vials and 3 ampoules 

 

1.5 mg/1 ml 

 

 

5. METHODS AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use 

 

Reconstitution required with the entire contents of the 1 ml solvent ampoule 

 

Intravenous use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 



15 

8. EXPIRY DATE 

 

EXP 

Use immediately after reconstitution or dilution 

 

 

9 SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator 

 

Do not freeze 

 

Store in the original package in order to protect from light 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

sanofi-aventis groupe 

54, rue La Boétie 

F - 75008 Paris 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/00/170/001 

 

 

13. BATCH NUMBER 

 

Batch 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 



16 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC:  

SN:  

NN:  



17 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

PACK OF 3 POWDER VIALS AND 3 SOLVENT AMPOULES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

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

 

rasburicase 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

sanofi-aventis groupe 

 

 

3. EXPIRY DATE 

 

EXP  

 

 

4. BATCH NUMBER 

 

Batch 

 

 

5. OTHER 



18 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

POWDER/VIAL 

 

 

1. NAME OF THE MEDICINAL PRODUCT  AND ROUTE(S) OF ADMINISTRATION 

 

Fasturtec 1.5 mg/ml powder for sterile concentrate 

rasburicase 

IV 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

1.5 mg 

 

 

6. OTHER 

 

 



19 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SOLVENT/AMPOULE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Solvent for rasburicase 1.5 mg 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

1 ml 

 

 

6. OTHER 

 



20 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PACK OF 1 POWDER VIAL and 1 SOLVENT AMPOULE 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

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

 

rasburicase 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

rasburicase 7.5 mg/5 ml 

 

rasburicase produced by genetechnology in Saccharomyces cerevisiae strain 

 

 

3. LIST OF EXCIPIENTS 

 

Powder also contains: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate 

dihydrate, sodium dihydrogen phosphate dihydrate 

 

Solvent: poloxamer 188, water for injection 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Powder and solvent for concentrate for solution for infusion 

1 vial and 1 ampoule 

 

7.5 mg/5 ml 

 

 

5. METHODS AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use 

 

Reconstitution required with the entire contents of the 5 ml solvent ampoule 

 

Intravenous use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 



21 

8. EXPIRY DATE 

 

EXP 

Use immediately after reconstitution or dilution 

 

 

9 SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator 

 

Do not freeze 

 

Store in the original package in order to protect from light 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

sanofi-aventis groupe 

54, rue La Boétie 

F - 75008 Paris 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/00/170/002 

 

 

13. BATCH NUMBER 

 

Batch  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 



22 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC:  

SN:  

NN:  



23 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

POWDER/VIAL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Fasturtec 1.5 mg/ml powder for sterile concentrate 

rasburicase 

IV 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot  

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

7.5 mg 

 

 

6. OTHER 

 

 



24 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SOLVENT/AMPOULE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Solvent for rasburicase 7.5 mg  

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot  

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

5 ml 

 

 

6. OTHER 

 



25 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

 



26 

Package leaflet: Information for the user 

 

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

rasburicase 

 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor, nurse or hospital pharmacist. 

- If you get any side effects, please talk to your doctor, nurse or hospital pharmacist. This includes 

any possible side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What Fasturtec is and what it is used for  

2. What you need to know before you are given Fasturtec 

3. How to use Fasturtec 

4. Possible side effects  

5. How to store Fasturtec 

6. Contents of the pack and other information 

 

 

1. What Fasturtec is and what it is used for  

 

Fasturtec contains the active ingredient rasburicase. 

Rasburicase is used to treat or prevent high blood levels of uric acid from occurring in adults, children 

and adolescents (aged 0 to 17 years) with disorders of the blood cells (haematological diseases) who 

are about to receive or are receiving chemotherapy treatment.  

 

When chemotherapy is given, cancer cells are destroyed, releasing large amounts of uric acid into the 

bloodstream.  

Fasturtec works by allowing uric acid to more easily be removed from the body by the kidneys.  

 

 

2. What you need to know before you are given Fasturtec 

 

Do not use Fasturtec if you: 

- are allergic (hypersensitive) to rasburicase, other uricases or any of the other ingredients of this 

medicine (listed in section 6). 

- have a history of haemolytic anaemia (an illness caused by red blood cells being abnormally 

broken down).  

 

Warning and precautions 

Talk to your doctor, nurse or hospital pharmacist if you have a history of any kind of allergy. 

Tell your doctor if you have ever had any allergic type reactions due to other medicines; Fasturtec can 

cause allergic-type reactions, such as severe anaphylaxis including anaphylactic shock (sudden life-

threatening or fatal allergic reactions).  

 

Tell your doctor immediately if you notice any of the following as you may need to stop treatment: 

• swelling of the face, lips, tongue or throat 
• coughing or wheezing 
• difficulty in breathing or swallowing 
• rash, itching or hives (nettle-type rash) on the skin 

 

These may be the first signs that a severe allergic reaction is happening. Your treatment with 

Fasturtec may need to be stopped, and you may need further treatment. 



27 

 

It is not known whether the chance of developing an allergic reaction is increased if treatment with 

Fasturtec is repeated. 

 

In case of disorders of the blood in which red blood cells are abnormally broken down (haemolysis) or 

abnormal blood pigment levels (methaemoglobinaemia), your doctor will immediately and 

permanently discontinue treatment with Fasturtec. 

 

Other medicines and Fasturtec  

Please tell your doctor if you are taking, or have recently taken, any other medicines, including 

medicines obtained without a prescription. 

 

Pregnancy and breast-feeding  

Tell your doctor if you are, or think you may be pregnant, or if you are breast-feeding. 

 

Driving and using machines 

No information on the ability to drive and use machines is available. 

 

 

3. How to use Fasturtec  

 

Fasturtec is to be given to you before or during the start of your course of chemotherapy. 

 

Fasturtec is injected slowly into a vein, which should take about 30 minutes. 

 

Your dose will be calculated according to your body weight.  

The recommended dose is 0.20 mg per kg of body weight per day in both children and adults. 

 

It will be given once a day, for up to 7 days.  

During treatment with Fasturtec, your doctor will carry out blood tests to check the levels of uric acid 

and decide how long you will be treated for.  

Your doctor may also test your blood to make sure that you do not develop any blood disorders. 

 

If you are given more Fasturtec than you should be 

If it does occur, the doctor will closely monitor the effects on your red blood cells and treat any 

symptoms that follow. 

 

If you have any further questions on the use of this medicine, ask your doctor, nurse or hospital 

pharmacist. 

 

 

4. Possible side effects  

 

Like all medicines, this medicine can cause side effects, although not everybody gets them.  

Fasturtec will be administered at the same time as other medicines that may also cause side effects.  

 

If you suddenly notice: 

- a swelling of the face, lips, tongue or other part of your body 

- a shortness of breath, wheezing or breathing problems  

- a rash, itching or hives  

Tell your doctor, nurse or hospital pharmacist immediately as these may be signs of a serious 

allergic reaction (anaphylaxis). These are rare (may affect up to 1 in 1,000 people). 

 

Very common side effects (may affect more than 1 in 10 people): 

- diarrhoea 

- vomiting 

- nausea 



28 

- headache 

- fever 

 

Common side effects (may affect up to 1 in 10 people): 

- allergic reactions, mainly rashes and urticaria. 

 

Uncommon side effects (may affect up to 1 in 100 people): 

- severe hypersensitivity reactions, such as anaphylaxis (rare) including anaphylactic shock 

(frequency not known) which may be fatal 

- low blood pressure (hypotension) 

- wheezing or difficulty in breathing (bronchospasm) 

- blood disorders such as a disorder of the blood in which red blood cells are abnormally broken 

down (haemolysis), destroyed (haemolytic anaemia), or abnormal blood pigment levels 

(methaemoglobinaemia)  

-  fits (convulsion).  

 

Rare (may affect up to 1 in 1,000 people): 

- runny or blocked nose, sneezing, facial pressure or pain (rhinitis). 

 

Frequency not known (frequency cannot be estimated from the available data) 

- involuntary muscle movements (muscle contraction involuntary). 
 

If you notice any of these, tell your doctor, nurse or hospital pharmacist. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor, nurse or hospital pharmacist. This includes any possible 

side effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Fasturtec 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date 

refers to the last day of that month. 

 

Store in a refrigerator (2°C – 8°C).  

Do not freeze. 

Store in the original package in order to protect from light. 

 

Do not use this medicine if you notice that the solution is unclear and/or contains particles. 

 

 

6. Contents of the pack and other information 

 

What Fasturtec contains 

 

- The active substance is rasburicase 1.5 mg/ml. Rasburicase is produced by genetechnology in a 

microorganism named Saccharomyces cerevisiae. 

- The other ingredients of the powder are: alanine, mannitol, disodium phosphate dodecahydrate, 

disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.  

- The other ingredients of the solvent are: poloxamer 188, water for injection. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


29 

What Fasturtec looks like and contents of the pack 

 

Fasturtec is provided as a powder for concentrate for solution for infusion (powder for sterile 

concentrate) with a solvent.  

The powder is an entire or broken white to off white pellet. 

The solvent is a colourless and clear liquid. 

 

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 vial with a rubber stopper and the solvent in a 2 ml clear glass ampoule. 

 

Pack of 1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent. The powder is supplied in 10 ml 

clear glass vial with a rubber stopper and the solvent in a 5 ml clear glass ampoule. 

 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

 

sanofi-aventis groupe  

54, rue La Boétie  

F-75008 Paris 

France 

 

Manufacturers  

 

Sanofi S.p.A. 

Via Valcanello, 4 

03012 Anagni (FR) 

Italy 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder:  

 

België/Belgique/Belgien 

Sanofi Belgium 

Tél/Tel: +32 (0)2 710 54 00 

 

Lietuva 

UAB «SANOFI-AVENTIS LIETUVA» 

Tel: +370 5 2755224 

 

България 

SANOFI BULGARIA EOOD 

Тел.: +359 (0)2 970 53 00 

 

Luxembourg/Luxemburg 

Sanofi Belgium  

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 

 

Česká republika 

sanofi-aventis, s.r.o. 

Tel: +420 233 086 111 

 

Magyarország 

sanofi-aventis zrt. 

Tel.: +36 1 505 0050 

 

Danmark 

Sanofi- A/S 

Tlf: +45 45 16 70 00 

 

Malta 

Sanofi S.p.A. 

Tel: + 39 02 39394275 

 

Deutschland 

Sanofi-Aventis Deutschland GmbH 

 
Tel.: 0800 04 36 996 

Tel. aus dem Ausland: +49 69 305 70 13 
 

 

 

Nederland 

sanofi-aventis Netherlands B.V. 

Tel: +31  (0)20 245 4000 

 



30 

Eesti 

sanofi-aventis Estonia OÜ 

Tel: +372 627 34 88 

 

Norge 

sanofi-aventis Norge AS 

Tlf: +47 67 10 71 00 

 

Ελλάδα 

sanofi-aventis AEBE 

Τηλ: +30 210 900 16 00 

 

Österreich 

sanofi-aventis GmbH 

Tel: +43 1 80 185 – 0 

 

España 

sanofi-aventis, S.A. 

Tel: +34 93 485 94 00 

 

Polska 

sanofi-aventis Sp. z o.o. 

Tel.: +48 22 280 00 00 

 

France 

sanofi-aventis France 

Tél: 0 800 222 555 

Appel depuis l’étranger : +33 1 57 63 23 23 

 

Portugal 

Sanofi - Produtos Farmacêuticos, Lda. 

Tel: +351 21 35 89 400 

 

Hrvatska 

sanofi-aventis Croatia d.o.o. 

Tel: +385 1 600 34 00 

 

România 

Sanofi Romania SRL 

Tel: +40 (0) 21 317 31 36 

 

Ireland 

sanofi-aventis Ireland Ltd. T/A SANOFI 

Tel: +353 (0) 1 403 56 00 

 

Slovenija 

sanofi-aventis d.o.o. 

Tel: +386 1 560 48 00 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

sanofi-aventis Pharma Slovakia s.r.o. 

Tel: +421 2 33 100 100 

 

Italia 

sanofi S.p.A. 

Tel: +39.800.536389 

 

Suomi/Finland 

Sanofi Oy 

Puh/Tel: +358 (0) 201 200 300 

 

Κύπρος 

sanofi-aventis Cyprus Ltd. 

Τηλ: +357 22 871600 

 

Sverige 

Sanofi AB 

Tel: +46 (0)8 634 50 00 

 

Latvija 

sanofi-aventis Latvia SIA 

Tel: +371 67 33 24 51 

 

United Kingdom 

Sanofi 

Tel: +44 (0) 845 372 7101 

 

 

 

This leaflet was last revised in {MM/YYYY} 

 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu  

 

 

 ---------------------------------------------------------------------------------------------------------------------------  

 

The following information is intended for healthcare professionals only:  

See section 3 “How to use Fasturtec” and practical information on preparation and handling given 

below.  

 



31 

Fasturtec must be reconstituted with the entire volume of the supplied solvent (e.g. 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 to be 

further diluted with sodium chloride 9 mg/ml (0.9%). 

 

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. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET