Voraxaze 1,000 units powder for solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Voraxaze 1,000 units powder for solution for injection
Glucarpidase
This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
Please read this entire leaflet carefully before receiving this medicine, as it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, consult your doctor.
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If you experience any side effects, consult your doctor, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Voraxaze is and what it is used for
- What you or your child should know before receiving Voraxaze
- How to take Voraxaze
- Possible side effects
- How to store Voraxaze
- Contents of the pack and other information
1. What Voraxaze is and what it is used for
The active substance in this medicine is glucarpidase, an enzyme that breaks down the cancer treatment drug methotrexate.
Voraxaze is indicated in adults and children older than 28 days who are receiving methotrexate for cancer treatment, but whose bodies are unable to eliminate methotrexate quickly enough and who are therefore at risk of serious side effects. The medicine breaks down methotrexate in the blood, reducing methotrexate levels and thereby helping to manage side effects and prevent them from worsening. The medicine acts very rapidly and can reduce methotrexate levels in the blood by more than 90% within 15 minutes. The medicine does not penetrate cells; therefore, it does not interfere with methotrexate already inside cancer cells, allowing methotrexate to continue working against cancer.
2. What you need to know before receiving Voraxaze
Do not take Voraxaze
- if you are allergic to glucarpidase or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before receiving Voraxaze.
You will receive this medicine as soon as your doctor decides you need it to prevent serious side effects from high-dose methotrexate.
This medicine alone cannot prevent or stop all side effects of high-dose 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 well your kidneys are functioning.
You will have tests to check this before and after treatment with this medicine.
Children and adolescents
This medicine may be given to children older than 28 days. The safety and efficacy of this medicine in children under 28 days of age have not been established.
Other medicines and Voraxaze
This medicine may affect the amount of leucovorin in your body, another product your doctor may give you to reduce methotrexate toxicity. As a precaution, your doctor will adjust the timing of your leucovorin and your Voraxaze doses to ensure that at least 2 hours elapse between administration of the two medicines. Your doctor will restart leucovorin administration no less than 2 hours after glucarpidase administration.
No other interactions between this medicine and other drugs have been reported during clinical studies.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor.
Since this medicine is only used in people who have already received methotrexate, which is known to cause harmful effects on the developing baby, no studies have been conducted to determine whether this medicine alone could cause harm to a developing fetus during pregnancy or whether it is excreted in breast milk.
Driving and using machines
The influence of this medicine on the ability to drive and use machines is none or negligible.
3. How to take Voraxaze
This medicine is administered by intravenous injection over a 5-minute interval. Your doctor will determine the appropriate dose for you based on your body weight. The recommended dose is 50 units per kilogram of body weight.
Because this medicine is given under medical supervision, it is unlikely that you will receive too much. If you think you have been given more than you should, consult your doctor or nurse.
You will be monitored for changes in the amount of methotrexate in your blood after treatment with this medicine.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
Tell your doctor or medical staff immediately if you experience any of the following:
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swelling of the throat, tightness in the chest, difficulty breathing
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swelling of the hands, feet, face, lips or mouth
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rash, with or without redness or swelling of the face
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tremors or chills without fever
If you experience any of the symptoms listed above, you may be having 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 tell your doctor or medical staff as soon as possible if you experience any of the following adverse reactions, which are also rare but have been reported during treatment with this medicine:
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fever
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headache
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tingling or prickling sensation on the skin (“pins and needles” sensation)
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burning sensation on the skin
If you experience any other adverse effect not mentioned in this leaflet, tell your doctor or medical staff.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly (see details below). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Voraxaze
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 and vial after EXP. The expiry date refers to the last day of the month indicated.
This medicine will be administered under medical supervision. Store in a refrigerator (between 2°C and 8°C).
Do not freeze.
Expiry date: This medicine must not be used after the expiry date stated on the vial or outer packaging. The pharmacist will check this before dispensing.
6. Contents of the pack and other information
Composition of Voraxaze
The active substance is glucarpidase.
The other components are lactose, tromethamine, and zinc acetate dihydrate.
Appearance of the product and contents of the pack
Each pack contains one vial with a white or almost white lyophilized powder, which is reconstituted with 1 ml of 0.9 % sterile sodium chloride solution (not included).
Marketing Authorization Holder and Manufacturer
Name and address of the Marketing Authorization Holder
SERB SAS
32 rue de Monceau
75008 Paris
France
Name and address of the manufacturer(s) responsible for batch release
Almac Pharma Services Limited
Seagoe Industrial Estate,
Portadown,
Craigavon,
BT63 5UA, UK (Northern Ireland)
Date of the most recent revision of this leaflet
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
The following information is intended for healthcare professionals only:
Each vial of Voraxaze must be reconstituted with 1 ml of 0.9 % sterile sodium chloride solution.
Reconstitution must be carried out immediately before use (do not further dilute). It must be administered intravenously as an intravenous bolus injection over a 5-minute period.
After reconstitution in 1 ml of 0.9 % sterile sodium chloride solution, the solution will contain 1,000 units of glucarpidase. A suitable syringe for small volumes should be used to withdraw the solution from the vials. It may not always be possible to withdraw the full 1 ml from the vial, but withdrawing at least 0.90 ml from the vial will provide an adequate amount of glucarpidase for administration.
Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.