FASTURTEC 1.5 mg/ml POWDER AND SOLVENT FOR CONCENTRATE FOR INFUSION SOLUTION

Introduction

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, talk to your doctor, nurse or hospital pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Fasturtec and what is it used for
2. What you need to know before you use Fasturtec
3. How to use Fasturtec
4. Possible side effects
5. Storage of Fasturtec
6. Contents of the pack and other information

1. What is Fasturtec and what is it used for

Fasturtec contains the active substance rasburicase.

Rasburicase is used to treat or prevent high levels of uric acid in the blood that occur in adults, children and adolescents (from 0 to 17 years) with blood cell disorders (haematological disorders) who are going to receive or are receiving chemotherapy.

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

Fasturtec works by helping the body get rid of uric acid through the kidneys.

2. What you need to know before you use Fasturtec

Do not use Fasturtec:

• if you are allergic(hypersensitive) to rasburicase, to another uricase or to any of the other ingredients of this medicine listed in section 6
• if you have a history of haemolytic anaemia(a disease caused by abnormal destruction of red blood cells).

Warnings and precautions

Tell your doctor, nurse or hospital pharmacist if you have a history of any type of allergy.

Tell your doctor if you have ever had any type of allergic reaction to other medicines; Fasturtec may cause allergic reactions such as severe anaphylaxis including anaphylactic shock (potentially fatal or life-threatening allergic reactions).

Tell your doctor immediatelyif you notice any of the following symptoms and may need to stop treatment:

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

These could be the first symptoms of a severe allergic reaction. You may need to stop your treatment with Fasturtec, and you may need additional treatments.

It is not known if the risk of developing an allergic reaction increases if treatment with Fasturtec is repeated.

If blood disorders occur in which red blood cells are abnormally destroyed (haemolysis) or abnormal levels of blood pigments (methaemoglobinemia) occur, your doctor will immediately and permanently stop treatment with Fasturtec.

Using Fasturtec with other medicines

Tell your doctor if you are using or have recently used any other medicines, including those obtained without a prescription.

Pregnancy and breast-feeding

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

Driving and using machines

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

Fasturtec contains sodium

This medicine contains up to 10.5 mg of sodium (from the salt used in cooking) per vial. This is equivalent to 0.53% of the maximum recommended daily intake of sodium for an adult.

3. How to use Fasturtec

Fasturtec will be given to you before or during your chemotherapy treatment.

Fasturtec is injected slowly into a vein over 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 and 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 perform blood tests to check uric acid levels and decide how long your treatment will last.

Your doctor may also perform blood tests to make sure you do not develop any blood disorders.

If you use more Fasturtec than you should

If this happens, your doctor will perform a rigorous periodic check of the red blood cells in your blood and treat any symptoms that appear.

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, Fasturtec can cause side effects, although not everybody gets them.

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

If you suddenly notice:

• swelling of the face, lips, tongue or other parts of your body
• difficulty breathing, wheezing or breathing problems
• skin rash, itching or hives.

Tell your doctor, nurse or hospital pharmacist immediately, as these symptoms can be a sign of a severe allergic reaction (anaphylaxis).These effects occur rarely (may affect up to 1 in 1,000 patients).

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

• diarrhoea
• vomiting
• nausea
• headache
• fever.

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

• allergic reactions, mainly skin rashes and hives.

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

• severe hypersensitivity reactions, such as anaphylaxis (rare) including anaphylactic shock (frequency not known) which could be fatal
• low blood pressure (hypotension)
• wheezing or breathing difficulties (bronchospasm)
• blood disorders such as problems where red blood cells are abnormally destroyed (haemolysis), destroyed (haemolytic anaemia), or there are abnormal levels of pigments in the blood (methaemoglobinemia)
• seizures (convulsions).

Rare side effects (may affect up to 1 in 1,000 patients):

• runny nose or nasal congestion, sneezing, facial pressure or pain (rhinitis).

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

• involuntary muscle movements (involuntary muscle contraction).

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

Reporting of side effects

If you experience 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. Storage of 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 the month shown.

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Store in the original package to protect from light.

Do not use this medicine if you notice that the solution is not transparent 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 genetic engineering in a microorganism called 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 injections.

Appearance and packaging

Fasturtec is presented as a powder for concentrate for solution for infusion (sterile concentrate powder) with a solvent.

The powder is white or off-white, agglomerated or non-agglomerated.

The solvent is a clear and colourless liquid.

Pack containing 3 vials of 1.5 mg of rasburicase and 3 ampoules of 1 ml of solvent. The powder is presented in 2 ml or 3 ml glass vials with a rubber stopper and the solvent in a 2 ml glass ampoule.

Pack containing 1 vial of 7.5 mg of rasburicase and 1 ampoule of 5 ml of solvent. The powder is presented in 10 ml glass vials with a rubber stopper and the solvent in a 5 ml 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

You can request more information about this medicine from the local representative of the marketing authorisation holder.

Date of last revision of this leaflet:

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 the practical information on preparation and handling described below.

Fasturtec should be reconstituted with the full volume of the supplied solvent (i.e. the 1.5 mg vial of rasburicase should be reconstituted with the 1 ml ampoule of solvent; the 7.5 mg vial of rasburicase should be reconstituted with the 5 ml ampoule of solvent). After reconstitution, a solution with a concentration of 1.5 mg/ml of rasburicase is obtained, which should be further diluted with a 9 mg/ml sodium chloride solution (0.9%).

Reconstitution of the solution:

Add the contents of one ampoule of solvent to a vial containing rasburicase and mix by gently rotating under controlled and validated aseptic conditions.

Do not shake.

Inspect visually before use. Only transparent and colourless solutions without particles should be used.

For single use only, any unused solution should be discarded.

The solvent does not contain any preservative. Therefore, the reconstituted solution should be diluted under controlled and validated aseptic conditions.

Dilution before infusion:

The required volume of reconstituted solution depends on the patient's body weight. It may be necessary to use several vials to obtain the required amount of rasburicase for an administration. The required volume of reconstituted solution, obtained from one or several vials, should be further diluted with a 9 mg/ml sodium chloride solution (0.9%) to obtain a total volume of 50 ml. The concentration of rasburicase of the final infusion solution depends on the patient's body weight.

The reconstituted solution does not contain any 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 the uric acid level of a patient, a strict sample handling procedure should be followed in order to minimize the ex vivo degradation of the analyte. Blood should be placed in pre-cooled tubes containing a heparinic anticoagulant. Samples should be immersed in an ice/water bath. Plasma samples should be prepared immediately by centrifugation in a pre-cooled centrifuge (4°C). Finally, the plasma should be kept in an ice/water bath and the uric acid level should be analyzed within 4 hours.