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.
This medicine is new. Please report side effects. See the full CMI for further details.
1. Why am I using IQIRVO?
IQIRVO contains the active ingredient elafibranor. IQIRVO is used to treat adult patients
with a type of liver disease known as primary biliary cholangitis (PBC).
2. What should I know before I use IQIRVO?
Do not use if you have ever had an allergic reaction to elafibranor 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 IQIRVO 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 IQIRVO.
4. How do I use IQIRVO?
Take one tablet, once a day, at about the same time each day.
Swallow the tablet whole with water.
5. What should I know while using IQIRVO?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using IQIRVO.
Tell your doctor immediately if you become pregnant.
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Things you should not do
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Do not stop using this medicine suddenly.
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Looking after your medicine
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Store below 30°C.
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6. Are there any side effects?
Abdominal pain, diarrhoea, nausea, vomiting, headache, constipation, gallstones (which
may cause abdominal pain, nausea, or vomiting), muscle pain, changes to the level
of an enzyme called creatine phosphokinase which may be seen in a blood test.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
elafibranor
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using IQIRVO. 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 IQIRVO.
Where to find information in this leaflet:
1. Why am I using IQIRVO?
IQIRVO contains the active ingredient elafibranor, known as a dual peroxisome proliferator-activated
receptor alpha/delta (PPARα/δ) agonist that targets the liver.
IQIRVO is used to treat adult patients with a type of liver disease known as primary
biliary cholangitis (PBC).
It helps to improve how your liver works by reducing the amount of bile acids produced
by the liver and reducing the build-up of bile. It also acts by reducing inflammation
of the liver.
IQIRVO may be given by itself or together with ursodeoxycholic acid (UDCA). Your doctor
will tell you how to take this medicine.
2. What should I know before I use IQIRVO?
Warnings
Do not use IQIRVO if:
you are allergic to elafibranor, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Check with your doctor if you:
have any other medical conditions (particularly if you have severely reduced liver
function).
take any medicines for any other condition, including cholesterol-lowering treatment
("statins").
experience unexplained muscle pain, soreness or weakness whilst taking IQIRVO.
experience symptoms of liver dysfunction which can include yellowing of the skin and
eyes (jaundice), belly (abdominal) pain, feeling sick, vomiting, tiredness, loss of
appetite and dark urine. You may need to go to hospital.
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.
Contact your doctor immediately if you become pregnant whilst taking IQIRVO due to
possible side effects on the unborn child.
If you are a woman of childbearing potential, you should use contraception whilst
taking this medicine and for 3 weeks after stopping treatment to avoid any harm to
the unborn child. Your doctor will advise you on the best contraception for you.
Your doctor may ask you to take a pregnancy test before starting treatment with IQIRVO
to ensure you are not pregnant prior to starting treatment.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not breast-feed whilst taking this medicine as it is unknown if IQIRVO will pass
to your child in your 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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect IQIRVO.
4. How do I use IQIRVO?
How much to take
The recommended dose is one tablet, once a day, at about the same time each day.
You can take IQIRVO with or without food.
Swallow the tablet whole with water.
Do not crush the tablet.
Follow the instructions provided and use IQIRVO until your doctor tells you to stop.
When to take IQIRVO
IQIRVO should be taken at about the same time each day.
If you forget to take IQIRVO
IQIRVO should be used regularly at the same time each day. If you miss your dose at
the usual time, take your next dose when it is due, skipping the missed dose.
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 take too much IQIRVO
If you think that you have taken too much IQIRVO, 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 IQIRVO?
Things you should do
Call your doctor straight away if you:
experience unexplained muscle pain, soreness or weakness whilst taking IQIRVO.
experience any of the symptoms under Serious Side Effects in Section 6.
Remind any doctor, dentist or pharmacist you visit that you are using IQIRVO.
Things you should not do
Do not stop using this medicine suddenly.
Monitoring
Your doctor may carry out blood tests and tell you to stop IQIRVO temporarily or permanently
if there are changes to either your liver function tests or the level of an enzyme
in your blood called creatine phosphokinase.
Looking after your medicine
Store below 30°C.
Follow the instructions on 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
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Less serious side effects
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What to do
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Nervous system related:
Headache
Gastrointestinal related:
Abdominal pain
Diarrhoea
Constipation
Nausea (feeling sick)
Vomiting (being sick)
Skin related:
Itchy rash
Muscle or bone related:
Muscle pain
Blood test related:
Changes to the level of an enzyme called creatine phosphokinase which may be seen
in a blood test
Changes to the level of a substance in the blood called creatinine which may be seen
in a blood test
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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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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 IQIRVO contains
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Active ingredient
(main ingredient)
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elafibranor
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
povidone
croscarmellose sodium
magnesium stearate
colloidal anhydrous silica
polyvinyl alcohol
titanium dioxide
macrogol 3350
purified talc
iron oxide yellow
iron oxide red
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Potential allergens
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n/a
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Do not take this medicine if you are allergic to any of these ingredients.
What IQIRVO looks like
IQIRVO 80 mg film-coated tablets are round, orange, and debossed with 'ELA 80' on
one side. Available in bottles of 30 tablets (AUST R 441770).
Australian Sponsor of IQIRVO
Ipsen Pty Ltd
Level 5, 627 Chapel Street
South Yarra VIC 3141
IQIRVO® is a registered trademark of GENFIT.
This leaflet was prepared in March 2025.