2. What should I know before I use VPRIV?
Do not use if you have ever had an allergic reaction to VPRIV 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.
VPRIV should not be used in children under the age of 4 years.
3. What if I am taking other medicines?
Some medicines may interfere with VPRIV and affect how it works.
4. How do I use VPRIV?
After VPRIV has been mixed with sterile water and normal saline, it is given as an
infusion into your vein in your arm over a period of 60 minutes.
The recommended dose is 60 Units of VPRIV for every kilogram you weigh.
5. What should I know while using VPRIV?
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Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using VPRIV.
If you become pregnant while using this medicine, tell your doctor immediately.
|
|
Driving or using machines
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This medicine is not expected to affect your ability to drive or use machines.
|
|
Looking after your medicine
|
Store VPRIV at 2°C - 8°C (in a refrigerator). Do not freeze it.
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6. Are there any side effects?
If you are treated with VPRIV you may experience infusion-related reactions such as
hypersensitivity reaction with symptoms like nausea, rash, back pain, chest discomfort
(chest tightness), hives, joint pain or headache. Apart from symptoms of hypersensitivity
reactions, infusion-related reactions might show as dizziness, high blood pressure,
tiredness or itching. A few patients receiving VPRIV have experienced severe allergic
reactions with symptoms of difficulty in breathing, swelling of the face, lips, and
tongue or throat.
Active ingredient(s):
Velaglucerase alfa ghu
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using VPRIV. 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 VPRIV.
Where to find information in this leaflet:
1. Why am I using VPRIV?
VPRIV contains the active ingredient velaglucerase alfa ghu. Velaglucerase alfa ghu is used to replace the missing or defective enzyme, glucocerebrosidase,
in patients with Gaucher disease. Gaucher disease is a genetic disorder caused by
a missing or defective enzyme named glucocerebrosidase. When this enzyme is missing
or does not work properly, a substance called glucocerebroside builds up inside cells
in the body. The build-up of this material causes the signs and symptoms found in
Gaucher disease.
VPRIV is used as a long-term enzyme replacement therapy (ERT) for patients with type
1 Gaucher disease.
2. What should I know before I use VPRIV?
Warnings
Do not use VPRIV if:
you are allergic to velaglucerase 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 VPRIV.
have previously used VPRIV and have had any unusual reactions such as skin rash or
"flu-like symptoms" to any injections of VPRIV in the past.
have had an allergic reaction to other enzyme replacement therapy you may have used
for Gaucher disease.
have allergy to any other medicines or substances, such as foods, preservatives or
dyes.
have any other medical conditions.
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 possible risks and benefits of using VPRIV if you are
pregnant or breastfeeding.
Use in Children
VPRIV should not be used in children under the age of 4 years.
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 VPRIV and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VPRIV.
4. How do I use VPRIV?
How much is given
The recommended dose is 60 Units of VPRIV for every kilogram you weigh.
Your doctor will monitor your response to treatment and may change your dose (up or
down) over time.
When you will be given VPRIV
VPRIV is given every other week.
Your doctor will tell you for how long you will need to be treated with VPRIV
How VPRIV is given
VPRIV is given by a doctor or nurse knowledgeable in the treatment of Gaucher disease.
VPRIV is dissolved in sterile water and normal saline. After dilution VPRIV is given
in a vein. This will usually be in your arm.
VPRIV is given as an infusion into your vein over a period of 60 minutes.
If you are currently being treated for Gaucher disease with another ERT and your doctor
wants to change you to VPRIV, you can initially receive VPRIV at the same dose and
frequency you had been receiving the other ERT.
If you are tolerating your infusions well in the clinic, your doctor or nurse may
administer your infusions at home under the direction of your specialist.
If you forget to use VPRIV
If you miss an infusion, consult your doctor and he/she will decide when you need
your next infusion.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much VPRIV
As VPRIV 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 VPRIV, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(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.
5. What should I know while using VPRIV?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using VPRIV.
If you become pregnant while using this medicine, tell your doctor immediately.
If you do not feel well while you are using VPRIV.
Remind any doctor, dentist or pharmacist you visit that you are using VPRIV.
Infusion-related reactions
If you are treated with VPRIV, you may experience side effects during or following
the infusion. These are called infusion-related reactions and might appear as a hypersensitivity
reaction with symptoms like nausea, rash, back pain, chest discomfort (chest tightness),
hives, joint pain or headache. Apart from symptoms of hypersensitivity reactions,
infusion-related reactions might show as dizziness, high blood pressure, tiredness,
fever, or itching.
You may be given additional medicines to treat or help prevent future reactions. If
the reaction is severe, your doctor will stop the infusion immediately and start giving
you appropriate medical treatment.
A few patients receiving VPRIV have experienced an allergic skin reaction such as
severe rash and itching. Severe allergic reactions with symptoms of difficulty in
breathing, swelling of the face, lips, and tongue or throat have occurred.
Tell your doctor immediately if you experience any of these side effects.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how VPRIV
affects you.
VPRIV is not expected to affect your ability to drive or use machines.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Store at 2-8°C (in a refrigerator). Do not freeze
Keep the vial in the outer carton in order to protect it from light.
VPRIV 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 should be discarded.
The infusion should be given immediately after preparation, unless otherwise instructed
by your physician. VPRIV does not contain any preservatives to prevent bacterial growth.
VPRIV will not be given to you if there is discolouration or other foreign particles
present.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
When to discard your medicine
Do not use this medicine after the expiry date printed on the pack.
Do not use this medicine if the packaging is torn or shows signs of tampering.
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.
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 VPRIV contains
|
Active ingredient
(main ingredient)
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velaglucerase alfa ghu
|
|
Other ingredients
(inactive ingredients)
|
sucrose
sodium citrate dihydrate
citric acid monohydrate
polysorbate 20
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Do not take this medicine if you are allergic to any of these ingredients.
What VPRIV looks like
VPRIV is a white to off-white powder. It is dissolved in sterile water and normal
saline for intravenous infusion. After reconstitution, the solution contains 100 Units
of velaglucerase alfa ghu per mL. (AUST R 180965).
VPRIV is supplied as a single vial in a carton.
Who distributes VPRIV
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 December 2025.
VPRIV is a registered trademark of Shire Human Genetic Therapies, Inc.
TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company
Limited.