Fasturtec – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Fasturtec, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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, n urse or hospital pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Fasturte c 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, ca ncer 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.
It is not known whether the chance of developing an allergic reaction is increased if trea tment 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 doct or 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 .
💊 3. How to use Fasturtec
Fasturtec is to be given to you before or during t he 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 b e 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).
27 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.
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. H ow to store Fasturtec
Keep thi s 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 gene technology 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.
28 – 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
Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France
Manufacturers
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:
België/ Belgique /Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 България Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480 Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 ( Belgique/Belgien) Česká republika Sanofi 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. r.l.
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 B.V.
Tel: +31 (0)20 245 4000 29 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Norge sanofi -aventis Norge AS Tlf: +47 67 10 71 00 Ελλάδα Sanofi -Aventis Μονοπρόσωπη ΑΕΒΕ 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 sp. z o.o.
Tel.: +48 22 280 00 00 France Sanofi Winthrop Industrie 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 Swixx Biopharma d.o.o.
Tel: +385 1 2078 500 România Sanofi Rom ania SRL Tel: +40 (0) 21 317 31 36 Ireland sanofi -aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00 Slovenija Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00 Ísland Vistor hf.
Sími : +354 535 7000 Slovenská republika Swixx Biopharma s.r.o.
Tel: + 421 2 208 33 600 Italia sanofi S. r.l.
Tel: 800536389 Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 Κύπρος C.A. Papaellinas Ltd.
Τηλ: + 357 22 741741 Sverige Sanofi AB Tel: +46 (0)8 634 50 00 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 50 United Kingdom (Northern Ireland) sanofi -aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525
This leaflet was last revised in {MM/YYYY}
Other source s of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu —————————————————————————————————————————–
🩺 Information 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.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Fasturtec (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/00/170).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.