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Cerezyme

[serah-ZIME]
Imiglucerase-rch [im-e-glue-sar-aze R.C.H] 200 U and 400 U, Powder for Solution for Infusion
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Cerezyme. It does not contain all the information that is known about Cerezyme. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Cerezyme is used for

Cerezyme is used as enzyme replacement therapy in Type I Gaucher disease, a disease in which the enzyme beta-glucocerebrosidase in the body does not work properly.

How it works

Patients with Gaucher disease do not produce enough of their own active enzyme, beta-glucocerebrosidase. The reduced beta-glucocerebrosidase activity in patients results in the accumulation of a fatty substance in the body called glucocerebroside. Cerezyme is an enzyme replacement therapy that is intended to restore a level of enzyme activity enough to remove the built up glucocerebroside and to prevent further build up.

Before you are given Cerezyme

When you or your child must not be given it

Do not use Cerezyme if you or your child have a known, severe, life-threatening allergic reaction to:
Cerezyme
any of the ingredients listed at the end of this leaflet
Symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
skin rash, itching or hives
If you are not sure whether you or your child should have Cerezyme, talk to your treating physician or nurse.

Before you or your child are given it

Tell your treating physician if you or your child have received Cerezyme or another drug and experienced any of the following:
life-threatening allergic reaction
difficulty breathing
Tell your treating physician if you or your child have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
Tell your treating physician if you are pregnant or intend to become pregnant.
There is no information available regarding the use of Cerezyme in pregnant women. Your treating physician will discuss the possible risks and benefits of having Cerezyme during pregnancy.
Tell your treating physician if you are breast-feeding.
It is not known whether Cerezyme passes into breast milk. Your treating physician will discuss the possible risks and benefits of having Cerezyme during breast-feeding.

Taking other medicines

Tell your treating physician or nurse if you or your child are taking any other medicines, or health supplements, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Cerezyme may interfere with each other. No studies have been carried out on drug interactions.

How Cerezyme is given

Cerezyme will be given to you or your child directly into the vein (intravenously) by a trained Healthcare professional in a hospital, in a clinic.
Your treating physician will decide on the dose and frequency of infusion that is most suitable.

If you are given too much (overdose)

There have been no reported overdoses of Cerezyme.
Your treating physician is trained to work out the correct dose and to contact the Australian Poisons Information Centre (telephone 13 11 26), or the New Zealand National Poisons Centre (telephone 0800 POISON or 0800 764 766) in case of an overdose.

Things you or your child must do

Keep appointments with your treating physician or clinic.
It is important to have the infusion with Cerezyme at the appropriate times to make sure the medicine has the best chance of providing effective treatment for the condition.

After having Cerezyme

Have any tests when your treating physician says to.
Your treating physician may wish to test your or your child's body's response to Cerezyme to make sure that it is working.

Things to be careful of

Be careful driving or operating machinery until you know how Cerezyme affects you.
Cerezyme is unlikely to have any effect on your ability to drive a car or operate machinery. Make sure that you know how you react to Cerezyme before you drive a car or operate machinery or do anything else that may be dangerous if you are dizzy, light-headed, tired or drowsy.

Side effects

Tell your treating physician or nurse as soon as possible if you or your child do not feel well after having Cerezyme.
Cerezyme may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You or your child may need urgent medical treatment if you notice some side effects.
Ask your treating physician or nurse to answer any questions you may have.
Tell your treating physician or pharmacist if you notice any of the following and they worry you:
nausea
vomiting
These are mild to moderate side effects of Cerezyme.
Tell your treating physician or nurse immediately if you notice any of the following:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
local reaction around the injection site such as redness, itchiness, tenderness, pain or discomfort, warmth, burning or stinging, swelling or the formation of hard lumps or scars
flushing or redness of the skin
headaches
stomach ache or cramp
diarrhoea
rash
tiredness
dizziness
These may be serious side effects of Cerezyme, which may require urgent medical attention.
Tell your treating physician if you notice anything else that is making you or your child feel unwell.
Other side effects not listed above may occur.

Storing Cerezyme

Cerezyme will usually be stored in the hospital or clinic pharmacy refrigeration at 2°C - 8°C.
Reconstituted and diluted Cerezyme should be protected from light.

Product Description

What it looks like

Cerezyme is a white to off-white powder before it is prepared for infusion and a clear, colourless solution after it has been prepared for infusion.

Ingredients

Active ingredient:
imiglucerase
Other ingredients:
sodium citrate dihydrate, mannitol, citric acid monohydrate and polysorbate 80.

Supplied by

In Australia this product is registered by:
Genzyme Australasia Pty Ltd
12-24 Talavera Road
Macquarie Park, NSW 2113
Australia
Toll Free Number (medical information): 1800 818 806
Email: [email protected]
AUST R 68331 and 74277
In New Zealand this product is registered by:
Sanofi-aventis new zealand limited
Level 8
56 Cawley Street
Ellerslie, Auckland
New Zealand
Toll Free Number (medical information): 0800 283 684
Email: [email protected]
CEREZYME® is a registered trademark of Genzyme Corporation, USA.
This leaflet was prepared in September 2016
cere-ccdsv04-cmiv1-09sep16