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 ZAVESCA?
ZAVESCA contains the active ingredient miglustat. ZAVESCA is used to treat mild to
moderate Type 1 Gaucher disease in adults and it is also used to treat Niemann-Pick
type C (NP-C) disease in children, adolescents and adults. For more information, see
Section
1. Why am I using ZAVESCA? in the full CMI.
2. What should I know before I use ZAVESCA?
Do not use if you have ever had an allergic reaction to ZAVESCA 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 ZAVESCA? in the full CMI.
3. What if I am taking other medicines?
4. How do I use ZAVESCA?
For Type 1 Gaucher disease, the usual dose for adults is one capsule (100 mg) three
times a day (morning, afternoon and evening).
For Niemann-Pick type C disease, the usual dose for adults and adolescents is two
capsules (200 mg) three times a day (morning, afternoon and evening). Your doctor
will work out the dose for children under the age of 12 years. If you have a problem
with your kidneys you may receive a lower starting dose.
ZAVESCA should be swallowed whole with water. It is recommended to take ZAVESCA without
food.
5. What should I know while using ZAVESCA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using ZAVESCA.
Tell your doctor if you become pregnant while you are taking ZAVESCA.
Men and women should use effective birth control while taking ZAVESCA.
Men should keep using effective birth control for 3 months after treatment with ZAVESCA
is stopped.
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Things you should not do
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Do not get pregnant or breastfeed while you are taking ZAVESCA.
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Driving or using machines
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ZAVESCA may make you feel dizzy. Do not drive or operate any tools or machines if
you feel dizzy.
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Looking after your medicine
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Store below 30°C. Keep your capsules in the blister pack out of reach of children
until it is time to take them.
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6. Are there any side effects?
Common, less serious side effects include abnormal blood test results which may cause symptoms like easy or excessive
bruising or bleeding and fatigue, stomach complaints (e.g. diarrhoea, wind, abdominal
pain, vomiting), weight loss or decreased appetite, lactose intolerance, insomnia,
depression, headache, dizziness, unclear speech, muscle spasms, joint or bone pain,
loss of strength, fatigue or feeling weak, chills, chest pain, rash, blurry vision,
frequent, abnormal urination.
Serious side effects include tremor, tingling, numbness or pain in your hands and feet, memory or thinking
problems.
Active ingredient: miglustat
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ZAVESCA. 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 ZAVESCA.
Where to find information in this leaflet:
1. Why am I using ZAVESCA?
ZAVESCA contains the active ingredient miglustat. ZAVESCA works by inhibiting the enzyme called 'glucosylceramide synthase' which is
responsible for the first step in the synthesis of most glycosphingolipids.
ZAVESCA is used to treat mild to moderate Type 1 Gaucher disease in adults and it
is also used to treat Niemann-Pick type C (NP-C) disease in children, adolescents
and adults.
Type 1 Gaucher disease is an inherited disease that you get from both of your parents.
People with Type 1 Gaucher disease are partially missing an enzyme that breaks down
a chemical in the body called glucosylceramide. Too much glucosylceramide causes an
increase in the size of the liver and spleen. It also causes bone disease and changes
in the blood.
ZAVESCA reduces the formation of glucosylceramide to a level the partially missing
enzyme can cope with.
You may be prescribed ZAVESCA if your doctor decides other treatments for this disease
are not right for you.
Niemann-Pick disease is an inherited disease that you get from both parents. If you
have NP-C, fats (glycosphingolipids) build up in the cells of your brain. This can
result in disturbances in neurological functions such as eye movements, balance, swallowing,
and memory, and in seizures.
2. What should I know before I use ZAVESCA?
Warnings
Do not use ZAVESCA if:
you are allergic to miglustat, 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 or have had any other medical conditions, especially the following:
kidney disease
liver disease
take any medicines for any other condition
Do not take ZAVESCA if you suffer from severe kidney disease.
Your doctor may perform the following tests before treatment and during treatment
with ZAVESCA:
an examination to check the nerves in your arms and legs
a test of your memory and thinking ability
blood test to check your platelet count
measurement of vitamin B12 levels (for GD-1 only)
if you are a child or adolescent with NP-C your doctor will also check measurements
of your growth
The reason these tests are done is that some patients have had tingling or numbness
in their hands and feet, or memory and thinking problems, while taking ZAVESCA. The
tests will help your doctor decide whether these effects are due to existing conditions,
or due to side effects of ZAVESCA.
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.
Do not take ZAVESCA if you are pregnant or planning to become pregnant.
ZAVESCA may harm your baby. You must use effective birth control while you are taking
ZAVESCA.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not take ZAVESCA if you are breastfeeding.
It is not known if this medicine passes into breast milk and if it can harm your baby.
ZAVESCA may harm sperm.
All men should use effective birth control while taking this medicine and for 3 months
after they stop taking it.
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 ZAVESCA 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 ZAVESCA.
4. How do I use ZAVESCA?
How much to take
Type 1 Gaucher disease
The usual dose for adults is one capsule (100 mg) three times a day (morning, afternoon
and evening).
Niemann-Pick type C disease
The usual dose for adults and adolescents is two capsules (200 mg) three times a day
(morning, afternoon and evening).
For children under the age of 12 years, the dose is determined by body surface area
(BSA m2); your doctor will work this out for you.
If you have a problem with your kidneys you may receive a lower starting dose.
Follow the instructions exactly as your doctor has instructed you to do and use ZAVESCA
until your doctor tells you to stop.
When to take ZAVESCA
Take ZAVESCA at the same time(s) each day.
You must take ZAVESCA every day.
Continue taking the medicine for as long as your doctor tells you to.
Do not stop taking it unless your doctor tells you to even if you feel better.
How to take ZAVESCA
ZAVESCA should be swallowed whole with water. It is recommended to take ZAVESCA without
food.
If you forget to use ZAVESCA
ZAVESCA should be used regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take it as soon as you remember and then go back to taking it as you would
normally.
Do not take a double dose to make up for the dose you missed.
If you use too much ZAVESCA
If you think that you have used too much ZAVESCA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(in Australia telephone 13 11 26 and in New Zealand telephone 0800 POISON or 0800 764
766), 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 ZAVESCA?
Things you should do
Tell your doctor if you become pregnant while you are taking ZAVESCA.
Men and women should use effective birth control while taking ZAVESCA.
Men should keep using effective birth control for 3 months after treatment with ZAVESCA
is stopped.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking
ZAVESCA.
If you have diarrhoea your doctor may ask you to change your diet to reduce your lactose
and carbohydrate intake such as sucrose (cane sugar), or not to take ZAVESCA together
with food, or to temporarily reduce your dose. In some cases, the doctor may prescribe
anti-diarrhoeal medications such as loperamide.
Cases of Crohn’s disease (an inflammatory disease affecting the gut) have been reported
in patients with Niemann-Pick type C disease treated with ZAVESCA.
If your diarrhoea does not respond to these measures, or if you have any other abdominal
complaint, consult your doctor. In such a case, your doctor may decide to conduct
further investigations.
Keep all of your doctor or clinic appointments.
Your doctor may do certain tests, including blood tests, from time to time to make
sure the medicine is working and to prevent unwanted side effects.
You may get some weight loss when you start treatment with ZAVESCA. If you do lose
some weight when you start treatment with ZAVESCA, don't worry. People usually stop
losing weight as treatment goes on. Talk to your doctor if this worries you.
Things you should not do
Do not get pregnant while you are taking ZAVESCA.
Do not breastfeed while on ZAVESCA.
Do not give ZAVESCA to anyone else, even if they have the same condition as you.
Do not stop taking ZAVESCA or change your dose without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ZAVESCA
affects you.
ZAVESCA may make you feel dizzy. Do not drive or operate any tools or machines if
you feel dizzy.
Looking after your medicine
Store below 30°C. Keep your capsules in the blister pack until it is time to take
them.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
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 ZAVESCA contains
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Active ingredient
(main ingredient)
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miglustat
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Other ingredients
(inactive ingredients)
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sodium starch glycollate
povidone
magnesium stearate
empty hard gelatin capsules size 4 white Op. 44.000/44.000 pure bovine (ARTG PI No
108031)
OPACODE monogramming ink S-1-277002 black (ARTG PI No 107581), OPACODE monogramming
ink S-1-27794 black (ARTG PI No 12104) or TekPrint SW-9008 Black Ink (ARTG PI No 2328)
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Do not take this medicine if you are allergic to any of these ingredients.
What ZAVESCA looks like
ZAVESCA are white, hard capsules with "OGT 918" printed in black on the cap and "100"
printed in black on the body.
ZAVESCA are supplied in blister packs of 90 capsules (AUST R 122957).
Who distributes ZAVESCA
JANSSEN-CILAG Pty Ltd
Macquarie Park NSW 2113 Australia
Telephone: 1800 226 334
NZ Office: Auckland New Zealand
Telephone: 0800 800 806
This leaflet was prepared in November 2024.
® ZAVESCA is a registered trademark of Janssen-Cilag.