• 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.

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

• 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).

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.

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.

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

• 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).

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 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.

• 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 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

Manufacturers

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.