Prospect: information for the patient

Voraxaze 1,000 units powder for injectable solution

Glucarpidase

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect thoroughly before receiving this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor.
• If you experience adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

1. What is Voraxaze and for what it is used

2. What you or your child need to know before starting to receive Voraxaze

3. How to take Voraxaze

4. Possible adverse effects

5. Storage of Voraxaze

6. Contents of the package and additional information

The active ingredient in this medication is glucarpidase, an enzyme that breaks down the medication methotrexate to treat cancer.

Voraxaze is indicated for adults and children over 28 days of age who are being administered methotrexate for cancer treatment, but their body is unable to eliminate methotrexate quickly enough and are at risk of severe side effects. The medication breaks down methotrexate in the blood, reducing methotrexate levels and thus helps to control side effects, preventing them from worsening. The medication acts very quickly and can reduce the amount of methotrexate in the blood by more than 90% in 15 minutes. The medication does not penetrate cells, so it does not prevent methotrexate that has already entered cancer cells from acting to treat cancer..

Do not take Voraxaze

• if you are allergic to glucarpidase or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before receiving Voraxaze.

You will receive this medication as soon as your doctor decides that you need it to prevent severe side effects of methotrexate.

This medication cannot by itself prevent or stop all side effects of high doses of methotrexate, and you will also be given other treatments and supportive care as needed.

It is important that your doctor knows how much methotrexate is in your blood and how your kidneys are functioning.

You will undergo tests to check this before and after treatment with this medication.

Children and adolescents

This medication may be administered to children over 28 days. The safety and efficacy of this medication in children under 28 days have not been determined.

Other medications and Voraxaze

This medication may affect the amount of folinic acid in your body, another product that your doctor may administer to reduce the toxicity of methotrexate. As a precaution, your doctor will adjust the timing of your folinic acid and your Voraxaze doses to ensure that at least 2 hours pass between the administration of the two medications. Your doctor will restart the administration of folinic acid no less than 2 hours after the administration of glucarpidase.

No other interactions between this medication and other medications have been reported during clinical studies.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor.

Since this medication is only used in people who have already received methotrexate, which is known to cause harm to the developing fetus, no studies have been conducted to determine if this medication by itself can cause harm to a developing fetus during pregnancy or if it is excreted in breast milk.

Driving and operating machinery

The influence of this medication on the ability to drive and use machines is negligible or

insignificant.

This medication is administered by intravenous injection over a period of 5 minutes. Your doctor will determine the appropriate dose for you based on your weight. The recommended dose is 50 units per kilogram of body weight.

Since the medication is administered under medical supervision, it is unlikely that you will receive too much. If you believe you have been given more than you should, consult your doctor or nurse.

You will be monitored to detect changes in the amount of methotrexate in your blood after treatment with this medication..

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Inform your doctor or medical staff immediately if you experience any of the following:

• throat inflammation, chest tightness, difficulty breathing
• inflammation in the hands, feet, face, lips, or mouth
• eruption, with or without redness or inflammation of the face
• shaking or chills without fever

If you experience any of the symptoms mentioned earlier, you may be experiencing a severe allergic reaction and may need immediate medical attention. These adverse effects (allergic reactions) are very rare, and if they occur, they usually occur on the day of treatment.

You should inform your doctor or medical staff as soon as possible if you experience any of the following rare adverse reactions, which have been reported during treatment with this medication:

• fever
• headache
• sensation of tingling or prickling in the skin (“pins and needles” sensation)
• sensation of burning in the skin

If you experience any other adverse effect not mentioned in this prospectus, inform your doctor or medical staff.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication

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

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

You will receive this medication under medical supervision..Store in refrigerator (between 2°C and 8°C).

Do not freeze.

Expiration Date: This medication will not be used after the expiration date that appears on the vial or outer packaging. The pharmacist will check this before dispensing..

Composition of Voraxaze

The active ingredient is glucarpidase.

The other components are lactose, trometamol, and zinc dihydrate acetate.

Appearance of the product and contents of the packaging

Each package contains a vial with a white or off-white lyophilized powder that is reconstituted with 1 ml of sterile sodium chloride solution 0.9% (not included).

Holder of the marketing authorization and responsible manufacturer

Name and address of the holder of the marketing authorization

SERB SAS

40 Avenue George V

75008 Paris

France

Name and address of the manufacturer(s) responsible for the release of the batches

Almac Pharma Services Limited

Seagoe Industrial Estate,

Portadown,

Craigavon,

BT63 5UA, UK (Northern Ireland)

Date of the last review of this leaflet

Other sources of information

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

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The following information is intended only for healthcare professionals:

Each vial of Voraxaze must be reconstituted in 1 ml of sterile sodium chloride solution 0.9%.

The reconstitution must be performed immediately prior to use (do not dilute further). It must be administered by intravenous injection over a period of 5 minutes.

After reconstituting in 1 ml of sterile sodium chloride solution 0.9%, it will contain 1,000 units of glucarpidase. A suitable syringe should be used to extract small volumes to extract the solution from the vials. It may not always be possible to extract 1 ml completely from the vial, but extracting at least 0.90 ml from the vial will provide an adequate amount of glucarpidase for administration.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.