Bylvay TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: odevixibat
Brand name
(ARTG)
: BYLVAY odevixibat 600 microgram capsule bottleConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
BYLVAY is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Capsule, hard
- Oral
- Size 0 hard capsules with opaque ivory body and cap with A600 printed in black ink on the cap.
Storage conditions
(ARTG)
- Store below 25 degrees Celsius
- Protect from Light
- Store in Original Container
- Shelf lifetime is 34 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 30 capsules pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient odevixibat
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information 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.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
