Summary of Product Characteristics: Information for the User

Fasturtec 1.5mg/ml powder and solvent for concentrate for solution for infusion

Rasburicase

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor, nurse or hospital pharmacist.

-If you experience any side effects, consult your doctor, nurse or hospital pharmacist, even if they are not listed in this leaflet. See section 4.

Fasturtec contains rasburicasa as its active ingredient.

Rasburicasa is used to treat or prevent high levels of uric acid in the blood that occur in adults, children, and adolescents (between 0 and 17 years old) with blood cell disorders (hematological diseases) who are about to receive or are receiving chemotherapy.

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

Fasturtec works by facilitating the elimination of uric acid from the body through the kidneys.

Do not use Fasturtec:

• if you areallergic(hypersensitive) to rasburicase, to another uricase or to any of the other components of this medication included in section 6
• if you have a history ofhemolytic anemia(a disease caused by abnormal destruction of red blood cells).

Warnings and precautions

Consult your doctor, nurse or hospital pharmacistif you have a history of any type of allergy.

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

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

• swelling in the face, lips, tongue or throat
• cough or labored breathing
• difficulty breathing or swallowing
• skin rash, itching or urticaria (irritation-type rash) on the skin

These may be the first signs of asevere allergic reactionoccurring. You may need to interrupt your Fasturtec treatment, and you may need additional treatments.

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

If blood disorders occur in which abnormal destruction of red blood cells (hemolysis) or abnormal levels of blood pigments (methemoglobinemia) occur, your doctor will immediately and permanently discontinue treatment with Fasturtec.

Use of Fasturtec with other medications

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

Pregnancy and breastfeeding

Inform your doctor if you are, or think you may be, pregnant, or if you are breastfeeding.

Driving and operating machinery

No information is available on the ability to drive and operate machinery.

Fasturtec contains sodium

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

Fasturtec will be administered before or during your chemotherapy treatment.

Fasturtec is injected slowly into a vein over approximately 30 minutes.

Your dose will be calculated based on your body weight.

The recommended dose is 0.20 mg per kilogram of body weight per day, for both children and adults.

It will be administered once a day, for up to 7 days.

During treatment with Fasturtec, your doctor will perform blood tests to check your uric acid levels and decide how long your treatment will last.

Your doctor may also perform blood tests to ensure that you do not develop any blood disorders.

If you use more Fasturtec than you should

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

If you have any other questions about the use of this medication, ask your doctor, nurse, or hospital pharmacist.

Like all medicines, Fasturtecmay cause side effects, although not everyone will experience them.

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

If you suddenly notice:

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

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

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

• diarrhea
• vomiting
• nausea
• headache
• fever.

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

• allergic reactions, mainly skin rashes and urticaria.

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

• severe hypersensitivity reactions, such as anaphylaxis (rare), including anaphylactic shock (unknown frequency) that could be fatal
• low blood pressure (hypotension)
• rapid breathing or breathing difficulties (bronchospasm)
• blood disorders such as abnormal destruction of red blood cells (hemolysis), destruction (hemolytic anemia), or abnormal levels of blood pigments (methemoglobinemia)
• seizures.

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

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

Unknown frequency (cannot be estimated from available data):

• involuntary muscle movements (involuntary muscle contraction).

If you experience any of these side effects, inform your doctor, nurse, or hospital pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, nurse, or hospital pharmacist, even if it is a possible side effect not listed in this leaflet.You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect it from light.

Do not use this medication if you observe that the solution is not transparent and/or contains particles.

Composition of Fasturtec

• The active ingredient is rasburicase 1.5 mg/ml. Rasburicase is obtained by genetic engineering in a microorganism called Saccharomyces cerevisiae.
• The other components of the powder are: alanine, mannitol, disodium dodecahydrate phosphate, disodium dihydrate phosphate, dihydrogen sodium dihydrate phosphate.
• The other components of the solvent are: poloxamer 188, water for injectable preparations.

Appearance of the product and contents of the packaging

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

The powder is white or off-white, in a non-agglomerated or agglomerated form.

The solvent is a transparent and colorless liquid.

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

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

Only some package sizes may be commercially available.

Marketing Authorization 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 medication by contacting the local representative of the marketing authorization holder.

Last review date of this leaflet:

Other sources of information

The detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu

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The following information is only for healthcare professionals:

See section 3 “How to use Fasturtec” and the practical information on preparation and handling described below.

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

Reconstitution of the solution:

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

Do not shake.

Inspect visually before use. Only use solutions that are transparent and colorless and free of particles.

Only for single use, any unused solution must be discarded.

The solvent does not contain any preservative. Therefore, the reconstituted solution must 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 administration. The required volume of reconstituted solution, obtained from one or several vials, must be diluted further with a solution of 9 mg/ml of sodium chloride (0.9%) to obtain a total volume of 50 ml. The concentration of rasburicase in the final infusion solution depends on the patient's body weight.

The reconstituted solution does not contain any preservative. Therefore, the diluted solution must be infused immediately.

Infusion:

The final solution must be infused over 30 minutes.

Sample handling:

If it is necessary to monitor the patient's uric acid level, a strict sample handling procedure must be followed to minimize ex vivo degradation of the analyte. Blood must be placed in pre-cooled tubes containing heparin anticoagulant. Samples must be submerged in an ice/water bath. Plasma samples must be prepared immediately by centrifugation in a pre-cooled centrifuge (4°C). Finally, plasma must be maintained in an ice/water bath and the patient's uric acid level must be analyzed within 4 hours.