Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Rasburicase may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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.
What you need to know before you take it
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. 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. Fasturtec contains sodium This medicine contains up to 10.5 mg sodium, (main component of cooking/table salt) per vial. This is equivalent to 0.53% of the recommended maximum daily dietary intake of sodium for an adult.
How to take it
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.
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
- 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).
G. Tartini, 2 2 0 1 5 8 – M I L A N O Tel. 02.375787 • e-mail: [email protected] CROMinFOTO s.n.c. Via
875830 (int. version 2)
–
GRAFICA – FOTOCOMPOSIZIONE
TYPE OF MATERIAL:
AZIENDA CERTIFICATA UNI EN ISO 9001:2015
DESCRIPTION:
LEAFLET FOLDED FASTURTEC 1.5/7.5 mg CODE:
VERSION: OLD CODE:
DIE CUT:
875830 000000 89038880 2 a 00000000 I011
COUNTRY:
UK
DIMENSIONS mm:
148 x 420 (148 x 210)
13 DIC 2022 LOGO VERSION: MIN. FONT SIZE:/LINE SPACING:
A2
COLOURS N°: COLOUR 1:
1
BLACK
11.5 pt.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
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.
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. 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 2 ml or 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 and Manufacturer Marketing Authorisation Holder Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Tel: 0800 035 2525 email: [email protected] Manufacturers Sanofi S.r.l. Via Valcanello, 4 03012 Anagni (FR) Italy
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in November 2022. 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. 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.
875830
G. Tartini, 2 2 0 1 5 8 – M I L A N O Tel. 02.375787 • e-mail: [email protected] CROMinFOTO s.n.c. Via
875830 (int. version 2)
–
GRAFICA – FOTOCOMPOSIZIONE
TYPE OF MATERIAL:
AZIENDA CERTIFICATA UNI EN ISO 9001:2015
DESCRIPTION:
LEAFLET FOLDED FASTURTEC 1.5/7.5 mg CODE:
VERSION: OLD CODE:
DIE CUT:
875830 000000 89038880 2 a 00000000 I011
COUNTRY:
UK
DIMENSIONS mm:
148 x 420 (148 x 210)
13 DIC 2022 LOGO VERSION: MIN. FONT SIZE:/LINE SPACING:
A2
COLOURS N°: COLOUR 1:
1
BLACK
11.5 pt.
Frequently asked questions about Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion
How do I take Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion?
Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion comes as infusion containing 1.5mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion?
The active substance in Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion is rasburicase.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: rasburicase
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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.
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).
This medicinal product contains up to 10.5 mg sodium per vial, equivalent to 0.53 % 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.
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 weighed 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 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 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
Methaemoglobinaemia
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- FasturtecRasburicasum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.