Fasturtec
rasburicase
rasburicase
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 Fasturtec is and what it is used for
What you need to know before you are given Fasturtec
How to use Fasturtec
Possible side effects
How to store Fasturtec
Contents of the pack and other information
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.
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).
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).
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.
Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are, or think you may be pregnant, or if you are breast-feeding.
No information on the ability to drive and use machines is available.
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.
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 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.
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.
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
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).
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.
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.
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.
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.
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.
sanofi-aventis groupe 54, rue La Boétie
F-75008 Paris France
Sanofi S.r.l.
Via Valcanello, 4
03012 Anagni (FR) Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00
Swixx Biopharma UAB Tel: +370 5 236 91 40
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Sanofi- A/S
Tlf: +45 45 16 70 00
Sanofi S.r.l.
Tel: + 39 02 39394275
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 04 36 996
Tel. aus dem Ausland: +49 69 305 70 13
Genzyme Europe B.V. Tel: +31 (0)20 245 4000
Swixx Biopharma OÜ Tel: +372 640 10 30
sanofi-aventis Norge AS Tlf: +47 67 10 71 00
sanofi-aventis AEBE
Τηλ: +30 210 900 16 00
sanofi-aventis GmbH Tel: +43 1 80 185 – 0
sanofi-aventis, S.A. Tel: +34 93 485 94 00
sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
sanofi-aventis France Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23
Sanofi - Produtos Farmacêuticos, Lda. Tel: +351 21 35 89 400
Swixx Biopharma d.o.o. Tel: +385 1 2078 500
Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00
Swixx Biopharma d.o.o. Tel: +386 1 235 51 00
Vistor hf.
Sími: +354 535 7000
sanofi S.r.l. Tel: 800536389
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741
Sanofi AB
Tel: +46 (0)8 634 50 00
Swixx Biopharma SIA Tel: +371 6 616 47 50
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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.