Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using CEREZYME?
CEREZYME contains the active ingredient imiglucerase-rch. Cerezyme is used as enzyme
replacement therapy to treat patients who have a confirmed diagnosis of Type I or
Type 3 Gaucher disease.
2. What should I know before I use Cerezyme?
Do not use if you have ever had an allergic reaction to Cerezyme or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Cerezyme and affect how it works.
4. How do I use Cerezyme?
Cerezyme is given through a drip into a vein (intravenously) by a trained healthcare
professional in a hospital, or in a clinic.
Your treating physician will decide on the dose and frequency of infusion that is
most suitable.
5. What should I know while using Cerezyme?
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Things you should do
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Keep appointments with your treating physician or clinic.
Have any tests when your treating physician says to.
Remind any nurse, doctor or pharmacist you visit that you are using Cerezyme.
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Things you should not do
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Do not stop using this medicine without speaking to your healthcare professional.
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Driving or using machines
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Be careful driving or operating machinery until you know how Cerezyme affects you.
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Looking after your medicine
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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.
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6. Are there any side effects?
Side effects include nausea & vomiting. Serious side effects include 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 or hives, tiredness, dizziness.
Active ingredient(s):
Imiglucerase-rch [im-e-glue-sar-aze R.C.H] 400 U, Powder for Solution for Infusion
Consumer Medicine Information (CMI)
This leaflet provides important information about using Cerezyme. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Cerezyme.
Where to find information in this leaflet:
1. Why am I using Cerezyme?
Cerezyme
contains the active ingredient imiglucerase. Cerezyme is used as enzyme replacement therapy 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), low numbers of platelets (a type of blood
cell) which can lead to a tendency to bleed, spleen or liver enlargement or bone disease.
Gaucher disease is a disease in which the enzyme β-glucocerebrosidase in the body
does not work properly.
Patients with Gaucher disease do not produce enough of their own active enzyme, β
-glucocerebrosidase. The reduced β -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.
2. What should I know before I use Cerezyme?
Warnings
Do not use Cerezyme if you or your child:
have a known, severe, life-threatening allergic reaction to Cerezyme, or 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.
Check with your doctor if you or your child:
have received Cerezyme or another drug and experienced life-threatening allergic reaction
or difficulty breathing.
have any allergies to any other medicines or any other substances, such as foods,
preservatives, or dyes.
have previously had surgery to remove the spleen.
If you are treated with Cerezyme, you may experience an allergic reaction while you
are being given the medicine or shortly after.
Your doctor may modify the administration of Cerezyme and may add medication before
or during the infusion to prevent the allergic reaction. In addition, your doctor
may perform tests to evaluate your allergic reaction.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor them. See additional information under
Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor 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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether Cerezyme passes into breast milk. Your treating physician
will discuss the possible risks and benefits of having Cerezyme during breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Cerezyme and affect how it works.
No studies have been carried out on drug interactions.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Cerezyme.
4. How do I use Cerezyme?
How Cerezyme is given
Cerezyme is given through a drip into a vein (intravenously) by a trained Healthcare
professional in a hospital, or in a clinic. The infusion can last 1 or 2 hours.
It is supplied as a powder which will be mixed with sterile water before it is given.
Your treating physician will decide on the dose and frequency of infusion that is
most suitable.
If you are given much Cerezyme
There have been no reported overdoses of Cerezyme.
Your treating physician is trained to work out the correct dose.
If you think that you have been given too much Cerezyme, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia or 0800 764 766 in New Zealand), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Cerezyme?
Things you or your child should 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.
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.
Remind any doctor, nurse or pharmacist you visit that you are using Cerezyme.
Things you or your child should not do.
Do not stop using this medicine without speaking to your healthcare professional.
Driving or using machines
Be careful before you drive or use any machines or tools 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.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Storage
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.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Cerezyme contains
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Active ingredient
(main ingredient)
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imiglucerase
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Other ingredients
(inactive ingredients)
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sodium citrate dihydrate, mannitol, citric acid monohydrate and polysorbate 80
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Do not take this medicine if you are allergic to any of these ingredients.
What Cerezyme 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 (AUST R 74277).
Who distributes Cerezyme
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in June 2024.
CEREZYME® is a registered trademark of Genzyme Corporation, USA.
czm-ccdsv6-cmiv5-12jun24