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, nurse, or pharmacist.
1. Why am I given SIMULECT?
SIMULECT contains the active ingredient basiliximab. SIMULECT is used when you are
receiving a new kidney from a transplant to reduce the likelihood of your body rejecting
2. What should I know before given SIMULECT?
Do not use if you have ever had an allergic reaction to SIMULECT 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 have had some vaccines recently, or are pregnant or plan to become pregnant or
are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with SIMULECT and affect how it works.
4. How do I receive SIMULECT?
SIMULECT will be given to you in a hospital by a doctor or nurse
5. What should I know while given SIMULECT?
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Things you should do
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Tell your doctor if you have had SIMULECT before. Use effective contraception to avoid
becoming pregnant
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Things you should not do
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Do not become pregnant or breastfeed
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Driving or using machines
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Do not drive or use machinery until you know how SIMULECT affects you.
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6. Are there any side effects?
Less serious side effects include dry or cracked lips, feeling sick, tired, or confused,
headache, change in weight, swelling of hands or feet, trouble sleeping, infections
or flu-like symptoms, shaking hands. More serious side effects include signs of an
allergic reaction including swelling of lips or tongue, spreading of rash or blisters,
breathing difficulties including wheezing or trouble breathing or fast heartbeat,
less wee than normal; less wee than normal going to the toilet.
Active ingredient:
basiliximab (bas-ee-licks-ee-mab)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SIMULECT. You should also speak to your doctor, nurse, or pharmacist if you would like further
information or if you have any concerns or questions about using SIMULECT.
Where to find information in this leaflet:
1. Why am I given SIMULECT?
SIMULECT contains the active ingredient basiliximab.
SIMULECT is a type of medicine known as an immunosuppressant. Immunosuppressants reduce
the body’s response to things that it recognises as “foreign" - including transplanted
organs. The body’s immune system thinks a transplanted organ is a foreign body and
will try to reject it. SIMULECT works by stopping the immune cells that attack transplanted
organs.
SIMULECT is given to adults, adolescents and children who are having a kidney transplant.
It helps prevent rejection of the transplanted kidney during the first 4 to 6 weeks
after the transplant operation, which is the time when the body is most likely to
try to reject the kidney. You will be given other medicines to help protect your new kidney during this time
(for instance, ciclosporin), and you will need to continue taking some of these medicines
every day after you leave the hospital.
SIMULECT is given to you only around the time of your transplant operation.
2. What should I know before given SIMULECT?
Warnings
Do not use SIMULECT if:
you are allergic to basiliximab, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
if you are pregnant or breast-feeding.
Check with your doctor if you:
take any other medicines for any other condition
have blood cancer ('lymphoma')
have previously received a transplant that failed after only a short time or,
have used this medicine before.
In this situation, you may have received SIMULECT. Your doctor will check this for
you and discuss with you the possibility of repeated treatment with SIMULECT.
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
It is very important to tell your doctor before your transplant operation if you are
pregnant, think that you may be pregnant, or intend to become pregnant.
You must use adequate contraception to prevent pregnancy during treatment and up to
4 months after receiving the last dose of SIMULECT. If you become pregnant during
this time, despite the use of contraceptive measures, you should tell your doctor
immediately.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Basiliximab,
the active ingredient of SIMULECT, may pass into your milk and affect your baby. Do
not breast-feed after having SIMULECT or in the 4 months after the last dose.
Use in older patients (aged 65 years and over)
SIMULECT can be given to older patients, but the information available is limited.
Your doctor may discuss this with you before you are given SIMULECT.
Vaccination
If you need to have a vaccination, seek your doctor’s advice first.
3. What if I am taking other medicines?
Tell your doctor, nurse, or pharmacist if you are taking any other medicines, including
any medicines or vaccines, vitamins or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
SIMULECT should not change the way other medicines work, nor should other medicines
change the way SIMULECT works. Nonetheless, it is important that you tell your doctor
if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect SIMULECT.
4. How do I receive SIMULECT?
How much is given
The usual dose is 20 mg in each infusion or injection.
For children and adolescents who weigh less than 35 kg, the dose given in each infusion
or injection is 10 mg.
When to receive SIMULECT
You will only be given SIMULECT if you are receiving a new kidney.
Normally, you will be given two doses of SIMULECT in hospital. The first dose is given
just before your transplant operation starts, and the second dose is given 4 days
after the operation.
A doctor or nurse will give you the treatment since SIMULECT has to be injected into
a vein. It can be either injected directly using a syringe or given slowly as an infusion
lasting 20 to 30 minutes.
If you are given too much SIMULECT
An overdose of SIMULECT is not likely to cause side effects straight away, but it
may weaken your immune system for longer. Your doctor will watch out for any effects
on your immune system and treat them if necessary.
5. What should I know while given SIMULECT?
Call your doctor straight away if:
you find out that you are pregnant while you are given SIMULECT or in the four months
following the last dose.
Your doctor can discuss with you the risks this medicine may have for your developing
baby.
Driving or using machines
There is no evidence to indicate that SIMULECT has an effect on your ability to drive
a car or use machines.
6. Are there any side effects?
All medicines can have side effects. Generally, patients who have had a kidney transplant
take several medicines as well as SIMULECT. You may get some side effects from your
medicines or feel unwell after your transplant. If you do experience any side effects,
most of them are minor and temporary. However, some side effects may need medical
attention.
Tell your doctor or nurse as soon as possible if you get any unexpected symptoms while you are being given SIMULECT, or during the 8 weeks afterwards, even if you
do not think that they are related to the medicine.
The lists below include side effects that were commonly reported during clinical trials
of SIMULECT.
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 SIMULECT contains
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Active ingredient
(main ingredient)
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basiliximab
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Other ingredients
(inactive ingredients)
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monobasic potassium phosphate
dibasic sodium phosphate
sodium chloride
sucrose
mannitol
glycine
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Potential allergens
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Simulect contains sodium and potassium.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially
‘sodium-free’.
This medicine contains potassium, less than 1 mmol (39 mg) per vial, i.e. essentially
'potassium-free'
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Do not take this medicine if you are allergic to any of these ingredients.
What SIMULECT looks like
SIMULECT is a sterile powder supplied in a glass vial. Not all marketed presentations
include an ampoule containing 5 mL of sterile water to dissolve the powder before
injection.
Who distributes SIMULECT
SIMULECT is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1 800 671 203
®= Registered Trademark
This leaflet was prepared in October 2024.
(sml101024c) based on Product Information (sml101024i)