Cerezyme 400 U powder for concentrate for solution for infusion
Imiglucerase
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet. please tell your doctor or pharmacist
In this leaflet:
- 1. What Cerezyme is and what it is used for.
- 2. Before you use Cerezyme.
- 3. How to use Cerezyme.
- 4. Possible side effects.
- 5. How to store Cerezyme.
- 6. Further Information
What Cerezyme Is And What It Is Used For
Cerezyme is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleeding easily (due to low numbers of platelets – a type of blood cell), spleen or liver enlargement or bone disease.
People with Gaucher disease have low levels of an enzyme called acid β-glucosidase. This enzyme helps the body control levels of glucosylceramide. Glucosylceramide is a natural substance in the body, made of sugar and fat. In Gaucher disease glucosylceramide levels can get too high.
Cerezyme is an artificial enzyme called imiglucerase -this can replace the natural enzyme acid β- glucosidase which is lacking or not active enough in patients with Gaucher disease.
The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.
Before You Use Cerezyme
Do not use Cerezyme
- If you are allergic (hypersensitive) to imiglucerase, or
- if you are allergic to any of the other ingredients of Cerezyme.
Take special care with Cerezyme
- If you are treated with Cerezyme, you may experience an allergic reaction while you are being given the medicine or shortly after. If you experience a reaction like this, you should tell your doctor immediately. Your doctor may test if you have an allergic reaction to imiglucerase.
- Some patients with Gaucher disease have high blood pressure in the lungs (pulmonary hypertension). The cause can be unknown, or it can be due to heart, lung or liver problems. It can occur whether the patient is treated with Cerezyme or not. But, if you suffer with any shortness of breath you should tell your doctor.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or think you may be pregnant. Cautious use of Cerezyme during pregnancy and breastfeeding is recommended.
How To Use Cerezyme
Instructions for proper use
Cerezyme is given through a drip into a vein (by intravenous infusion).
It is supplied as a powder which will be mixed with sterile water before it is given.
Cerezyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.
Your dose will be specific to you. Your doctor will work out your dose based on how severe your symptoms are, and other factors. The recommended dose of Cerezyme is 60 units/kg body weight given once every 2 weeks.
Your doctor will keep a close check on your response to your treatment, and may change your dose (up or down) until he/she finds the best dose to control your symptoms.
Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose. This might be every 6 to 12 months.
There is no information on the effect of Cerezyme on brain-based symptoms of patients with chronic neuronopathic Gaucher disease. Therefore no special dosage regimen can be recommended.
The ICGG Gaucher Registry
You can ask your doctor to register your patient information into the “ICGG Gaucher Registry”. The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works. This should lead to improvement in the safe and effective use of Cerezyme. Your patient data will be registered anonymously– nobody will know it is information about you.
If you use more Cerezyme than you should
There are no cases of overdose of Cerezyme reported.
If you forget to use Cerezyme
If you have missed an infusion, please contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Cerezyme can cause side effects, although not everybody gets them.
If you experience any serious side effects or side effects not listed below, please tell your doctor immediately.
Common side effects (occurring in more than 1 in 100 patients) are:
- breathlessness
- hives/ localised swelling of the skin or lining of the mouth or throat
- itching
- rash
Uncommon side effects (occurring in more than 1 in 1000 patients) are:
- dizziness
- headache
- a sensation of tingling, pricking, burning or numbness of the skin
- increased heart rate
- bluish skin
- flushing
- fall in blood pressure
- vomiting
- nausea
- abdominal cramping
- diarrhoea
- pain in the joints
- infusion site discomfort
- infusion site burning
- infusion site swelling
- injection site sterile abcess
- chest discomfort
- fever
- rigors
- fatigue
- backache
Some side effects were seen primarily while patients were being given the medicine or shortly after. These have included itching, flushing, hives/localised swelling of the skin or lining of the mouth or throat, chest discomfort, increased heart rate, bluish skin, breathlessness, a sensation of tingling, pricking, burning or numbness of the skin, fall in blood pressure and backache. If you experience any of these symptoms, please tell your doctor immediately. You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids).
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Cerezyme
Keep out of the reach and sight of children.
Unopened vials:
Store in a refrigerator (2°C – 8°C)
Do not use Cerezyme after the expiry date printed on the labelling after the letters “EXP”. The expiry date refers to the last date of that month.
Diluted solution:
It is recommended that Cerezyme is used immediately after it has been mixed with sterile water. The mixed solution in the vial cannot be stored and should be promptly diluted in an infusion bag; only the diluted solution can be held for up to 24 hours if it is kept cool (2°C – 8°C) and in the dark.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Cerezyme contains
- The active substance is imiglucerase. Imiglucerase is a modified form of the human enzyme acid β-glucosidase produced by recombinant DNA technology. One vial contains 400 units of imiglucerase. After reconstitution, the solution contains 40 units of imiglucerase per ml.
- Other ingredients are:
- Mannitol
- Sodium citrate
- Citric acid monohydrate
- Polysorbate 80
Important information about some of the ingredients of Cerezyme
This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution. To be taken into consideration by patients on a controlled sodium diet.
What Cerezyme looks like and contents of the pack
Cerezyme, 400 U, is presented as a powder for concentrate for solution for infusion (in a vial- pack size of 1, 5 or 25). Not all pack sizes may be marketed.
Cerezyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom/Ireland
This leaflet was last approved in: 06/2009.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/. There are also links to other websites about rare diseases and treatments.
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