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 Myozyme?
Myozyme contains the active ingredient alglucosidase alfa-rch. Alglucosidase alfa-rch
is a type of protein. Myozyme is used to treat Pompe disease, a rare genetic disease
in which the level of an enzyme called acid alfa-glucosidase is missing or is lower
than in healthy individuals. Myozyme is used as a replacement to the lack of or low
levels of the enzyme.
2. What should I know before I use Myozyme?
Do not use if you have ever had an allergic reaction to alglucosidase alfa-rch 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 Myozyme and affect how it works.
4. How do I use Myozyme?
The recommended dosage for Myozyme is 20 mg/kg of body weight once every two weeks.
Myozyme will be given to you or your child directly into the vein (intravenously)
by a trained health care professional in a hospital or a clinic.
5. What should I know while using Myozyme?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Myozyme.
Keep appointments with your treating physician or clinic.
Have any tests when your treating physician says to.
Call your doctor straight away if you or your child have experienced loss in mobility
since the last Myozyme infusion.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Myozyme
affects you.
Make sure that you know how you react to Myozyme before you do anything else that
may be dangerous if you are dizzy, light-headed, tired or drowsy.
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Looking after your medicine
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Myozyme should be stored in the hospital or clinic pharmacy under refrigeration at
2°C - 8°C.
After reconstitution and dilution, Myozyme should be protected from light.
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6. Are there any side effects?
Common side effects include nausea, feeling hot, headache, sleepiness, fainting, burning
sensation and increased tear production. Serious side effects include dizziness and
lightheadedness, bluish tinged skin, fast heart beat/rate, fever or high temperature,
itchy rash, hives, itching or rash, flushing or redness of skin, pale skin, redness,
swelling or pain around infusion site, severe skin reactions, difficulty breathing,
wheezing or coughing, fast breathing, vomiting or retching, cramps, irritability or
agitation, increased sweating and swelling of the face.
Active ingredient(s):
Alglucosidase alfa-rch [al-glue-co-SIDE-aze al-fa R.C.H]
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Myozyme. 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 Myozyme.
Where to find information in this leaflet:
1. Why am I using Myozyme?
Myozyme contains the active ingredient alglucosidase alfa-rch.
Alglucosidase alfa-rch is a type of protein.
Myozyme is used to treat Pompe disease, a rare genetic disease in which the level
of an enzyme called acid alfa-glucosidase is missing or is lower than in healthy individuals.
Myozyme is used as a replacement to the lack of or low levels of the enzyme.
Myozyme is available only with a doctor's prescription. Only the treating physician
can start the treatment and supervise the ongoing treatment.
Myozyme is to be given only to the person for whom it has been prescribed.
How Myozyme works
Patients with Pompe disease do not produce enough of their own enzyme, acid alfa-glucosidase.
The reduced acid alfa-glucosidase activity in patients results in the build up of
glycogen in many parts of the body. Myozyme is an enzyme replacement therapy that
is intended to restore a level of enzyme activity sufficient to remove the accumulated
glycogen and to prevent further accumulation.
Pompe disease has been described under 2 forms: early-onset and late-onset. Your
physician is in the best position to determine the risks and benefits of treatment
with Myozyme and he will discuss it with you or your child.
Ask your treating physician if you have any questions about why it has been prescribed
for you or your child.
This medicine is only available with a physician’s prescription.
It is not addictive.
2. What should I know before I use Myozyme?
Warnings
Do not use Myozyme if:
you are allergic to alglucosidase alfa-rch, or any of the ingredients listed at the
end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
or your child have allergies to: any other medicines and/or any other substances,
such as foods, preservatives or dyes
or your child have experienced loss in mobility since the last Myozyme infusion.
Your treating physician may recommend to perform blood tests to monitor your or your
child’s body’s response to Myozyme to make sure that it is working, especially if
you or your child have experienced a loss of mobility since the last Myozyme infusion,
to check your or your child’s immune reaction to Myozyme active ingredient or if you
have experienced certain side effects.
If you are not sure whether you or your child should have Myozyme, talk to your treating
physician or nurse.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for 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 limited experience of the use of Myozyme in pregnant women. Your treating
physician will discuss the possible risks and benefits of having Myozyme during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
There is limited information available regarding the use of Myozyme in breastfeeding
women. Myozyme may be found in breast milk. The continuation of treatment for Pompe
disease during pregnancy and breast-feeding should be individualised. If you are pregnant
or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
If you have not told your treating physician about any of the above, tell them before
you or your child are given Myozyme.
Tell your treating physician if you or your child have received Myozyme or another
drug, and experienced any of the following conditions:
life-threatening allergic reaction
difficulty breathing
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.
Tell your treating physician or nurse if you or your child are receiving treatment
with medicines that suppress your immune system, because you or your child have Pompe
disease, there is a risk that you get a severe infection of your airways or lungs.
Using these medicines to suppress the immune system may further increase this risk.
Some medicines may interfere with Myozyme and affect how it works.
Tell your treating physician or nurse if you or your child are using other medicines
as these medicines may be affected by Myozyme or may affect how well it works (different
amounts of these medicines may be needed or different medicines may need to be taken).
Your treating physician or nurse will advise you and decide whether or not to give
you or your child Myozyme.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Myozyme.
4. How do I use Myozyme?
How much to use
The recommended dosage for Myozyme is 20 mg/kg of body weight once every two weeks.
Myozyme will be given to you or your child directly into the vein (intravenously)
by a trained health care professional in a hospital or a clinic.
Follow the instructions provided and use Myozyme until your doctor tells you to stop.
When to use Myozyme
Myozyme is given by infusion once every 2 weeks.
How to use Myozyme
Myozyme will be prepared and given to you or your child by a treating physician or
a nurse.
Myozyme will be reconstituted, diluted and should be protected from light before it
is given to you or your child. It is given as a drip through a needle placed into
a vein (intravenous infusion), usually in the arm. This takes approximately 4 hours.
A few patients have had an allergic reaction to Myozyme. Your or your child’s treating
physician or nurse will check for allergic reactions during the infusion. Your or
your child’s treating physician may decide to check for allergic reactions some time
after the infusion. You may need to be given pre-treatment medicines to prevent an
allergic reaction (e.g. antihistamines and/or corticosteroids) or to reduce fever
(antipyretics).
In studies, doctors have used medicines to suppress the immune system to reduce the
production of antibodies. Because you or your child have Pompe disease, there is a
risk that you could get a severe infection of your airways or lungs. Using these medicines
to suppress the immune system may further increase this risk.
Infusion with Myozyme should start as soon as possible after the medicine has been
reconstituted and diluted. If not used immediately, the solution must be stored at
2°C - 8°C and infused within 24 hours of reconstitution and dilution.
You may be at an increased risk of an infusion associated reaction (IAR), if you are
given Myozyme at a higher dose or infusion rate than recommended. If you experience
IARs you should tell your doctor immediately.
How long to use it
It is important to continue treatment with Myozyme unless your treating physician
tells you or your child to stop.
If you miss a dose of Myozyme
If have any concerns, talk to your doctor and arrange another visit as soon as possible.
If you received too much Myozyme
Overdose is most unlikely because your physician gives the infusions. If you have
any concerns, ask your doctor.
5. What should I know while using Myozyme?
Things you should do
Keep appointments with your treating physician or clinic.
It is important to have the infusion with Myozyme at the appropriate times to make
sure the medicine has the best chance of providing treatment for the condition.
Have any tests when your treating physician says to.
Your treating physician may recommend to perform blood tests to monitor your or your
child’s body’s response to Myozyme to make sure that it is working, especially if
you or your child have experienced a loss of mobility since the last Myozyme infusion
and to check your or your child’s immune reaction to Myozyme active ingredient.
Call your doctor straight away if you:
or your child have experienced loss in mobility since the last Myozyme infusion.
Remind any doctor, dentist or pharmacist you visit that you are using Myozyme.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Myozyme
affects you.
The effect of Myozyme on your ability to drive a car or operate machinery has not
been studied. Make sure that you know how you react to Myozyme 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
Myozyme should be stored in the hospital or clinic pharmacy under refrigeration at
2°C - 8°C.
After reconstitution and dilution, Myozyme should be protected from light.
Follow the instructions in the carton on how to take care of your medicine properly.
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
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
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 Myozyme contains
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Active ingredient
(main ingredient)
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alglucosidase alfa
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Other ingredients
(inactive ingredients)
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mannitol
monobasic sodium phosphate monohydrate
dibasic sodium phosphate heptahydrate
polysorbate 80
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Potential allergens
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No
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Do not take this medicine if you are allergic to any of these ingredients.
What Myozyme looks like
Myozyme is supplied in a clear glass vial and is a white to off-white powder before
it is prepared for infusion and a clear, colourless to pale yellow solution when it
is prepared for infusion, which may contain particles. (Aust R 136005).
Who distributes Myozyme
In Australia this product is registered by:
sanofi-aventis australia pty ltd.
12-24 Talavera Road
Macquarie Park NSW 2113
Australia
Toll Free Number: (medical information): 1800 818 806
Myozyme® is a registered trademark of Genzyme Corporation, USA.
This leaflet was prepared in November 2023.
myoz-ccdsv11-cmi6-09nov23