Cerezyme 400 U Powder for concentrate for solution for infusion

Cerezyme^® 400 Units

powder for concentrate for solution for infusion

Imiglucerase

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Cerezyme contains the active substance imiglucerase and 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 bleed 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.

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 doctor may advise that you can be treated at home provided you meet certain criteria. Please contact your doctor if you would like to be treated at home.

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 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 have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people):

• breathlessness
• coughing
• hives/ localised swelling of the skin or lining of the mouth or throat
• itching
• rash

Uncommon (may affect up to 1 in 100 people):

• 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 abscess
• chest discomfort
• fever
• rigors
• fatigue
• backache

Rare (may affect up to 1 in 1,000 people):

• anaphylactoid reactions

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).

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

Do not use this medicine after the expiry date printed on the labelling after the letters “EXP”. The expiry date refers to the last day of that month.

Unopened vials:

Store in a refrigerator (2°C – 8°C)

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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.