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 Fasturtec?
Fasturtec contains the active ingredient rasburicase. Fasturtec is used to prevent
and treat high blood levels of uric acid that may arise from chemotherapy for cancers
of the blood such as leukaemia or lymphoma.
2. What should I know before I use Fasturtec?
Do not use if you have ever had an allergic reaction to Fasturtec 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 Fasturtec and affect how it works.
4. How do I use Fasturtec?
The dose of Fasturtec is calculated according to your body weight. The usual dose
is 0.2 mg for each kilogram you weigh.
Fasturtec is given to you as an infusion into one of your veins (this is called an
intravenous infusion).
5. What should I know while using Fasturtec?
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using Fasturtec.
|
Things you should not do
|
Give Fasturtec to anyone else, even if they have the same condition as you.
Use Fasturtec to treat any other complaints unless your doctor tells you to.
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how Fasturtec
affects you.
|
Drinking alcohol
|
Tell your doctor that you drink alcohol.
|
Looking after your medicine
|
Fasturtec will normally be stored in the pharmacy or on the ward. The injection is
kept refrigerated (2°C to 8°C). Do not freeze it.
|
6. Are there any side effects?
Common side effects: Fever, nausea, vomiting, diarrhoea, headache, skin rash and hives.
These side effects can also occur as a result of the chemotherapy medicine you may
be receiving.
Active ingredient:
rasburicase
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Fasturtec. 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 Fasturtec.
Where to find information in this leaflet:
1. Why am I using Fasturtec?
Fasturtec contains the active ingredient rasburicase. Fasturtec is a recombinant form of the urate-oxidase enzyme, which converts uric
acid into a substance called allantoin that is easier for your kidneys to remove from
the body.
Fasturtec is used to prevent and treat high blood levels of uric acid that may arise
from chemotherapy for cancers of the blood such as leukaemia or lymphoma.
2. What should I know before I use Fasturtec?
Warnings
Do not use Fasturtec if you:
are allergic to rasburicase, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
have G6PD (glucose-6-phosphate dehydrogenase) deficiency
have any condition that causes haemolytic anaemia
Check with your doctor if you:
have a previous history of allergy, asthma, or allergic reactions
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. Fasturtec
is not recommended for use during pregnancy unless your doctor has discussed the risks
and benefits with you.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
whether Fasturtec passes into breast milk.
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 Fasturtec 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 Fasturtec.
4. How do I use Fasturtec?
How much to take / use
The dose of Fasturtec is calculated according to your body weight. The usual dose
is 0.2 mg for each kilogram you weigh. Your doctor may change the dose in some circumstances.
When to take / use Fasturtec
Fasturtec is normally given once a day, and may be given for a number of days.
How is Fasturtec given
Fasturtec is given to you as an infusion into one of your veins (this is called an
intravenous infusion).
The infusion will be given over a 30 minute time span.
Fasturtec must only be given under supervision of a trained doctor.
If you are given too much Fasturtec (overdose)
Your doctor will decide what dose of Fasturtec you need, and this will be given under
close supervision. The risk of an overdose in these circumstances is low. In the event
of an overdose, your doctor will decide on the necessary treatment.
Your doctor or pharmacist has information on how to recognise symptoms of an overdose.
Ask your doctor or pharmacist if you have any concerns.
5. What should I know while using Fasturtec?
Things you should do
Tell any other healthcare professionals treating you that you are currently using
Fasturtec.
Things you should not do
Give Fasturtec to anyone else, even if they have the same condition as you.
Use Fasturtec to treat any other complaints unless your doctor tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Fasturtec
affects you.
Fasturtec's effect on your ability to drive or operate machinery has not been studied.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol consumption while being treated with Fasturtec has not been studied.
Looking after your medicine
Fasturtec will normally be stored in the pharmacy or on the ward. The injection is
kept refrigerated (2°C to 8°C). Do not freeze it.
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
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 Fasturtec contains
Active ingredient
(main ingredient)
|
Rasburicase 1.5 mg
|
Other ingredients
(inactive ingredients)
|
Alanine
Mannitol
Dibasic sodium phosphate dihydrate
Monobasic disodium phosphate
Dibasic sodium phosphate dodecahydrate
Poloxamer
Water for injections
|
Do not take this medicine if you are allergic to any of these ingredients.
What Fasturtec looks like
Fasturtec comes as a clear glass vial containing a white powder, along with an ampoule
containing liquid to dissolve the powder. AUST R 80836
Who distributes Fasturtec
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in July 2024.