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REPLAGAL®
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.
REPLAGAL contains the active ingredient agalsidase alfa ghu. REPLAGAL is used to treat
Fabry Disease.
For more information, see Section 1. Why am I using REPLAGAL? in the full CMI.
Do not use if you have ever had an allergic reaction to REPLAGAL 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.
For more information, see Section 2. What should I know before I use REPLAGAL? in the full CMI.
Some medicines may interfere with REPLAGAL and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Before REPLAGAL is given to you, it is mixed with 0.9% sodium chloride intravenous
solution (saline). The prepared solution will be infused into a vein in your arm over
a 40 minute period.
The usual dose is an infusion of 0.2 mg for every kg you weigh.
More instructions can be found in Section 4. How do I use REPLAGAL? in the full CMI.
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Things you should do
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Remind any doctor or pharmacist you visit that you are using REPLAGAL.
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Things you should not do
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Do not use any other medications while using REPLAGAL unless you have discussed this
with your doctor or pharmacist.
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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 REPLAGAL
affects you.
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Looking after your medicine
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Store at 2-8°C (in a refrigerator). Do not freeze.
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For more information, see Section 5. What should I know while using REPLAGAL? in the full CMI.
The most commonly reported side effects are allergic reaction, headache, nausea, fatigue,
diarrhoea, cough, vomiting, dizziness, pain or swelling of joints, back or limb pain,
fever, flu-like symptoms, tingling or numbness in fingers or toes, abdominal pain
or discomfort, shortness of breath, chest pain, palpitations, muscle pain, unusual
weakness, feeling cold, rash, swelling of the hands or feet, ears ringing, and tremor
or shakes.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
REPLAGAL
Active ingredient(s):
agalsidase alfa ghu
Consumer Medicine Information (CMI)
This leaflet provides important information about using REPLAGAL. 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 REPLAGAL.
Where to find information in this leaflet:
REPLAGAL contains the active ingredient agalsidase alfa ghu. Agalsidase alfa ghu is a form of the human enzyme α-galactosidase A. It is produced
by switching on the gene for α-galactosidase A in cells. The enzyme is then removed
from the cells and made into a sterile concentrate for solution for infusion.
REPLAGAL is used to treat Fabry Disease. REPLAGAL is given as enzyme replacement therapy
when the level of enzyme in the body is lower than normal as in Fabry Disease.
Do not use REPLAGAL if:
you are allergic to agalsidase alfa ghu, 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:
think you are allergic to any of the ingredients contained in REPLAGAL
have previously used REPLAGAL and have had any unusual reactions such as skin rash
or "flu-like symptoms" to any injections of REPLAGAL in the past
take any medicines for any other condition.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the risks and benefits of using REPLAGAL if you are pregnant
or breastfeeding.
Use in Children
REPLAGAL has not been studied in children less than 6 years old, and only limited
information is available in children 7-18 years of age.
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 REPLAGAL and affect how it works. These include:
chloroquine, a medicine used to prevent or treat malaria
amiodarone, a medicine used to treat life-threatening heart rhythm problems
benoquin, a medicine used lighten the skin in people with a skin condition called
vitiligo
gentamicin, a medicine used to treat serious bacterial infections.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect REPLAGAL.
How much is given
The usual dose is an infusion of 0.2 mg for every kg you weigh. This would be about
14 mg or 4 vials (glass bottles) of REPLAGAL for an average size (70 kg) individual.
How REPLAGAL is given
REPLAGAL has to be diluted in 0.9% sodium chloride intravenous solution (saline) before
use. After dilution REPLAGAL is given in a vein. This will usually be in your arm.
Each time you are treated it will take 40 minutes for REPLAGAL to be given to you
in your vein. Your treatment will be supervised by a doctor who specialises in the
treatment of Fabry Disease. You may need to be treated with REPLAGAL long term.
If your conditions have been stabilised in a controlled hospital setting and you are
tolerating your infusion well, a doctor or nurse may administer REPLAGAL infusion
to you at your home.
If you forget to use REPLAGAL
If you miss an infusion, the enzyme levels which REPLAGAL is intended to replace will
remain low. Consult your doctor and he/she will decide when you need your next infusion.
If you stop using REPLAGAL, the level of the enzyme which is responsible for Fabry
Disease will remain low and the symptoms of the disease will not be treated.
If you use too much REPLAGAL
As REPLAGAL is usually given to you by infusion under the supervision of a doctor
or nurse, it is unlikely that you will receive too much. In the unlikely event that
this may occur, your doctor will arrange the appropriate care.
If you think that you have used too much REPLAGAL, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(by calling 13 11 26), 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.
Make sure that all of your doctors and pharmacists know you are using REPLAGAL. Remind them if any new medicines are about to be started. Things you should not do
Do not use any other medications while using REPLAGAL unless you have discussed this
with your doctor or pharmacist.
Do not use REPLAGAL to treat any complaint other than that directed by your doctor.
Do not give REPLAGAL to someone else even if his/her symptoms are the same.
Infusion-related reactions
13.7% of patients treated with REPLAGAL in clinical studies have experienced reactions
during or following infusion of REPLAGAL. Most reactions were mild. The most common
symptoms were chills, headache, nausea, fever, facial flushing (redness) and tiredness.
These reactions have generally occurred 2-4 months after the start of treatment and
then decreased over time. However, they may begin more than 1 year after the start
of treatment. More serious reactions with fever, chills, fast heart rate, hives, vomiting,
swelling of the throat and tongue causing difficulty swallowing and breathing, have
been reported uncommonly.
Most of the time you can still be given REPLAGAL even if these symptoms occur. If
you experience an allergic side effect following the administration of REPLAGAL, you
should immediately contact your doctor.
If symptoms occur during your infusion:
Your doctor or nurse may stop the infusion temporarily (5-10 min) until the symptoms
go away and then begin the infusion again
Your doctor or nurse may also treat the symptoms with other medicines (antihistamines
or corticosteroids)
Driving or using machines
Be careful before you drive or use any machines or tools until you know how REPLAGAL
affects you.
REPLAGAL is not expected to affect your ability to drive a car or operate machinery.
Looking after your medicine
Store at 2-8°C (in a refrigerator). Do not freeze.
REPLAGAL will usually be kept in the pharmacy department of the hospital where you
are receiving the treatment and the infusion prepared there for you individually.
Any unused solution from the preparation would be discarded.
The infusion should be given immediately after preparation, unless otherwise instructed
by your physician. REPLAGAL does not contain any preservatives to prevent bacterial
growth.
REPLAGAL will not be given to you if there is discolouration or other foreign particles
present. A slight haziness is normal.
Keep it where young children cannot reach it.
Do not use this medicine after the expiry date.
Do not use this medicine if the package is torn or shows signs of tampering.
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
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Less serious side effects
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What to do
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headache or dizziness
fever
flushing
nausea
tingling or numbness or pain in fingers or toes
change in the taste of food
increased tear secretion
ears ringing
tremors or shakes
prolonged sleep or difficulty staying awake
palpitations
increased blood pressure or low blood pressure
chest tightness/pain
cough
hoarseness, sore or tight throat
runny nose
vomiting
abdominal pain/discomfort
diarrhoea
acne
red or itchy or mottled skin
rash at the infusion site
back or limb pain
swelling of the extremities or joints
muscle pain
unusual weakness
fatigue
feeling cold or hot
general pain/discomfort
flu-like symptoms
generally feeling unwell
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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signs of infection
shortness of breath
changes in the way your heart beats (for example, if you notice it beating faster)
pain or tenderness in chest, muscles or joints
light-headedness
itching or rash
sweating
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Tell your doctor as soon as possible if you notice any of these side effects.
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allergic reactions – symptoms include swelling of the hands, feet, ankles, face, lips,
mouth or throat which may cause difficulty in swallowing or breathing and hives
high fever
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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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.
This medicine is only available with a doctor's prescription.
What REPLAGAL contains
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Active ingredient
(main ingredient)
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agalsidase alfa ghu
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Other ingredients
(inactive ingredients)
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sodium phosphate - monobasic monohydrate
sodium hydroxide
polysorbate 20
sodium chloride
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Do not take this medicine if you are allergic to any of these ingredients.
What REPLAGAL looks like
REPLAGAL is a sterile, clear and colourless solution intended for intravenous administration.
A minute amount of fine particulate matter, causing the solution to appear slightly
hazy, may be present. (AUST R 82818).
REPLAGAL is supplied as a single vial in a carton.
Who distributes REPLAGAL
Australia:
Takeda Pharmaceuticals Australia Pty Ltd
Level 39, 225 George Street
Sydney NSW 2000
Australia
Telephone: 1800 012 612
New Zealand:
Takeda New Zealand Limited
Level 10, 21 Queen Street
Auckland 1010
New Zealand
Telephone: 0508 169 077
This leaflet was prepared in November 2025.
REPLAGAL is a registered trademark of Shire Human Genetic Therapies, Inc.
TAKEDA and the TAKEDA Logo are registered trademarks of Takeda Pharmaceutical Company
Limited.
