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 taking BYLVAY?
BYLVAY contains the active ingredient odevixibat. BYLVAY is used to treat progressive
familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older. PFIC
is a liver disease caused by build-up of bile acids (cholestasis) that gets worse
over time and is often accompanied with severe itching.
2. What should I know before I take BYLVAY?
Do not use if you or your child have ever had an allergic reaction to BYLVAY or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you or your child:
have any other medical conditions or you are taking any medicines for any other condition.
are pregnant or plan to become pregnant or are breastfeeding.
have been diagnosed with a complete absence or lack of function of bile salt export
pump protein.
have severely reduced liver function.
have reduced stomach or bowel motility, or reduced circulation of bile acids between
liver, bile and small intestine due to medicines, surgical procedures or diseases
other than PFIC since these may reduce the effect of odevixibat.
3. What if I am taking other medicines?
Some medicines may interfere with BYLVAY and affect how it works.
4. How do I take BYLVAY?
The dose of BYLVAY is based on your/ your child's weight. Your doctor will work out
the right number and strength of capsules to take. The recommended dose is 40 micrograms
odevixibat per kilogram body weight once daily.
The 200 and 600 micrograms capsules are intended to be opened and sprinkled on food.
5. What should I know while taking BYLVAY?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you or your child are taking
BYLVAY.
Should you experience diarrhoea while taking BYLVAY, make sure to drink enough fluids,
such as water or juice, to avoid becoming dehydrated.
Make sure to keep all of your doctor's appointments so that they can monitor your
condition.
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Things you should not do
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Do not stop taking BYLVAY or lower the dosage without first discussing with your doctor.
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Looking after your medicine
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Keep your medicine in the original container in a cool, dry place where the temperature
stays below 25°C.
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6. Are there any side effects?
Common side effects of BYLVAY are: diarrhoea, including diarrhoea with bloody stool,
soft stools and abdominal (belly) pain.
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:
odevixibat
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BYLVAY. 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 BYLVAY.
Where to find information in this leaflet:
1. Why am I taking BYLVAY?
BYLVAY contains the active ingredient odevixibat. BYLVAY is a medicine which increases the removal of substances called bile acids
from the body. Bile acids are found in the digestive fluid called bile, which is produced
by the liver and released into the gut. Odevixibat blocks the mechanism that returns
bile acids to the blood after they have done their job in the gut. This allows them
to pass out of the body in the stool.
BYLVAY is used to treat progressive familial intrahepatic cholestasis (PFIC) in patients
aged 6 months or older. PFIC is a liver disease caused by build-up of bile acids (cholestasis)
that gets worse over time and is often accompanied with severe itching.
2. What should I know before I take BYLVAY?
Warnings
Do not use BYLVAY if:
you are allergic to odevixibat, 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/your child:
have any other medical conditions.
take any medicines for any other condition.
have been diagnosed with a complete absence or lack of function of bile salt export
pump protein.
have severely reduced liver function.
have reduced stomach or bowel motility, or reduced circulation of bile acids between
liver, bile and small intestine due to medicines, surgical procedures or diseases
other than PFIC since these may reduce the effect of odevixibat.
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?
Use in infants
BYLVAY is not recommended for babies under 6 months because it is not known if the
medicine is safe and effective in this age group.
Pregnancy and breastfeeding
Check with your doctor before taking this medicine if you are pregnant or breast-feeding,
think you may be pregnant, or intend to become pregnant.
BYLVAY is not recommended during pregnancy. Use of a barrier contraceptive method
is recommended since oral contraceptives may be affected by odevixibat.
It is not known if odevixibat can pass into breast milk and affect the baby. Your
doctor will help you to decide whether to stop breast-feeding or avoid BYLVAY treatment,
considering the benefit of breast-feeding to the baby and BYLVAY to the mother.
Diarrhoea
Talk to your doctor if you develop diarrhoea while taking BYLVAY. Drink enough water,
or other fluids, to prevent dehydration while you have diarrhoea.
Liver function tests
Increased levels in liver function tests can occur in some patients receiving BYLVAY.
Assessment of liver function is recommended for all patients prior to BYLVAY treatment.
Your doctor may recommend more frequent monitoring if you or your child have elevated
liver function test results.
Blood tests
Your doctor may recommend assessment of Vitamin A, D and E blood levels as BYLVAY
may impact the absorption of fat-soluble vitamins.
Your doctor may also monitor the blood clotting value, called INR, prior to and during
BYLVAY treatment.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you or your child 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 BYLVAY and affect how it works.
Treatment with odevixibat may affect the absorption of fat-soluble vitamins such as
Vitamin A, D and E, and some medicines, including oral contraceptives.
Check with your/your child's doctor or pharmacist if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect BYLVAY.
4. How do I take BYLVAY?
Always take this medicine exactly as your/your child's doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
How much to take
Treatment must be started and supervised by a doctor experienced in the management
of progressive liver disease with reduced bile flow.
The dose of BYLVAY is based on weight. Your/your child's doctor will work out the
right number and strength of capsules for you to take.
The recommended dose is:
40 micrograms odevixibat per kilogram body weight once daily
If the medicine is not working well enough after 3 months, your doctor may increase
the dose to 120 micrograms odevixibat per kilogram body weight (up to a maximum of
7,200 micrograms once daily).
Follow the instructions provided and use BYLVAY until your doctor tells you to stop.
When to take BYLVAY
BYLVAY capsules should be taken once daily in the morning with or without food.
How to take BYLVAY
All capsules can be either swallowed whole with a glass of water or opened and sprinkled
on food.
The larger 200 and 600 micrograms capsules are intended to be opened and sprinkled
on food but may be swallowed whole.
The smaller 400 micrograms and 1200 micrograms capsules are intended to be swallowed
whole but may be opened and sprinkled on food.
Instructions to open capsules and sprinkle the contents on food:
Place a small amount of soft food into a bowl (2 tablespoons/30 mL of yoghurt, apple
sauce, banana or carrot puree, chocolate pudding, rice pudding or oatmeal porridge).
Food should be at or below room temperature.
Hold the capsule horizontally at both ends, twist in opposite directions.
Pull apart to empty the contents into the bowl of soft food.
Gently tap the capsule to ensure that all pellets come out.
Repeat the previous step if the dose requires more than one capsule.
Gently mix the contents of the capsule into the soft food.
Take the entire dose immediately after mixing. Do not store the mixture for future
use.
Drink a glass of water following the dose.
Dispose of the empty capsule shells.
If the medicine does not improve your/your child's condition after 6 months of continuous
daily treatment, your doctor may recommend an alternative treatment.
If you forget to take BYLVAY
BYLVAY should be taken regularly at the same time each morning.
If it is almost time for your/your child's next dose, skip the dose you missed and
take the next dose when you are meant to.
Do not take/give a double dose to make up for the dose you missed.
If you or your child take too much BYLVAY
If you think that you/your child may have taken too much BYLVAY, you/they 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, taking this leaflet with
you.
You should do this even if there are no signs of discomfort or poisoning.
You/your child may experience some of the following symptoms: diarrhoea, stomach and
bowel problems.
5. What should I know while taking BYLVAY?
Things you should do
Should you/your child experience episodes of diarrhoea while taking BYLVAY, make sure
to drink enough fluids, such as water or juice, to avoid becoming dehydrated.
Make sure to keep all of your doctor's appointments so that they can monitor your/your
child's condition.
Remind any doctor, dentist or pharmacist you visit that you/your child are using BYLVAY.
Things you should not do
Do not stop taking BYLVAY or lower the dosage without first discussing with your doctor.
Do not take BYLVAY to treat any other complaints.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BYLVAY
affects you.
BYLVAY is not known to have an influence on the ability to drive or capacity to use
machinery.
Looking after your medicine
Keep the medicine in the original container.
If you take it out of its original container it may not keep well.
Store the capsules in a cool, dry place where the temperature stays below 25°C.
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/your child 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/your child's doctor or pharmacist
if you have any further questions about side effects.
Less serious side effects
Tell your/your child's 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 BYLVAY contains
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Active ingredient
(main ingredient)
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odevixibat (as sesquihydrate)
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Other ingredients
(inactive ingredients)
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Capsule content: hypromellose, microcrystalline cellulose
Capsule shell: titanium dioxide, iron oxide yellow, iron oxide red (400 and 1200 micrograms
strengths only)
Printing ink: shellac, propylene glycol, strong ammonia solution, isopropyl alcohol,
butan-1-ol, iron oxide black
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Do not take this medicine if you are allergic to any of these ingredients.
What BYLVAY looks like
BYLVAY capsules are opaque, hard gelatin capsules containing white to off-white pellets.
The different strengths of BYLVAY capsules can be identified as follows (the Australian
registration number 'AUST R' is also provided):
BYLVAY 200 micrograms hard capsules are size 0 capsules with an opaque white body
and an opaque ivory cap with “A200” printed in black ink on the cap. (AUST R 419590)
BYLVAY 400 micrograms hard capsules are size 3 capsules with an opaque white body
and a medium orange opaque cap with “A400” printed in black ink on the cap. (AUST
R 419591)
BYLVAY 600 micrograms hard capsules are size 0 capsules with an opaque ivory body
and cap with “A600” printed in black ink on the cap. (AUST R 419593
BYLVAY 1200 micrograms hard capsules are size 3 capsules with a medium orange opaque
body and cap with “A1200” printed in black ink on the cap. (AUST R 419592)
Australian sponsor of BYLVAY
Ipsen Pty Ltd
Level 5, 627 Chapel Street
South Yarra VIC 3134
This leaflet was prepared in March 2025.