[my-oh-ZIME]
Alglucosidase alfa-rch [al-glue-co-SIDE-aze al-fa R.C.H] 50 mg/10 mL, Powder for Concentrate
for Solution for Infusion
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Myozyme.
It does not contain all the available information about Myozyme.
It does not take the place of talking to your treating physician or a trained health
care professional.
All medicines have risks and benefits. Your treating physician has weighed the risks
of you or your child having Myozyme against the benefits they expect it will have.
If you have any concerns about this medicine, ask your doctor or nurse.
Keep this leaflet.
You may need to read it again.
What it is used for
What Myozyme is used for
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
contains the active ingredient alglucosidase alfa-rch. Alglucosidase alfa-rch is a
type of protein.
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 it 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.
Before you are given MYOZYME
When you or your child must not be given it
Do not take Myozyme if you or your child have a known, severe, life-threatening allergic
reaction to any of the ingredients listed at the end if this leaflet.
Symptoms of a severe allergic reaction may include:
shortness of breath, difficulty breathing
skin rash, itching or hives
very fast heart rate
swelling of the face, lips or tongue
symptoms of low blood pressure.
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.
Tell your treating physician if you or your child have experienced loss in mobility
since the last Myozyme infusion.
If you are not sure whether you or your child should have Myozyme, talk to your treating
physician or nurse.
Before you or your child are given it
Tell your treating physician if your child have received Myozyme or another drug,
and experienced any of the following conditions:
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 Myozyme in pregnant women.
Your treating physician will discuss the possible risks and benefits of having Myozyme
during pregnancy.
Tell your treating physician if you are breast-feeding or planning to breast-feed.
There is limited information available regarding the use of Myozyme in breastfeeding
women. It is not known whether Myozyme passes into breast milk. If there is a need
to consider using Myozyme while you are breastfeeding or planning to breast-feed your
treating physician will discuss with you the benefits and risks of using it.
If you have not told your treating physician about any of the above, tell them before
you or your child are given Myozyme.
Taking other medicines
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.
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.
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.
How MYOZYME is given
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.
How to use it
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.
When it is given
Myozyme is given by infusion once every 2 weeks.
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 are given too much (overdose)
There have been no reported overdoses of Myozyme.
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.
While you are being given Myozyme
Things you or your child must 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.
Tell your treating physician if you or your child have experienced loss in mobility
since the last Myozyme infusion.
Things to be careful of
Be careful driving or operating machinery 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.
Side effects
Tell your treating physician or nurse as soon as possible if you or your child do
not feel well after having Myozyme.
All medicines may have unwanted side effects. Sometimes they are serious, but most
of the time they are not. Your treating physician has weighed the risks of using
this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects.
You or your child may not experience any of them.
Ask your treating physician or nurse to answer any questions you may have.
Tell your treating physician or nurse as soon as possible if you notice any of the
following and they worry you:
nausea
feeling hot
headache
increased tear production
These are mild to moderate side effects of Myozyme.
Tell your treating physician or nurse immediately if you notice any of the following:
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
swelling of the face.
These may be serious side effects of Myozyme, 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 MYOZYME
Myozyme should be stored in the hospital or clinic pharmacy under refrigeration at
2°C - 8°C. Reconstituted and diluted Myozyme should be protected from light.
Product description
What it 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.
Ingredients
Active ingredient:
alglucosidase alfa
Other ingredients:
mannitol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate
and polysorbate 80.
Supplier
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
AUST R 136005
In New Zealand this product is registered by:
sanofi-aventis New Zealand limited
Level 8
56 Cawley Street
Ellerslie, Auckland
New Zealand
New Zealand Free Call: 0800 283 684
Myozyme® is a registered trademark of Genzyme Corporation, USA.
This leaflet was prepared in August 2020.
myoz-ccdsv9-cmiv4-06aug20