What is Bylvay (odevixibat) for?
Bylvay (odevixibat) is a treatment for pruritus in patients 3 months and older with PFIC. It works by blocking the ileal bile acid transporter (IBAT).
It’s not effective for PFIC type 2 with certain ABCB11 variants. This is because it can’t work well with non-functional or absent BSEP-3.
Bylvay comes in two forms: oral pellets and capsules. The pellets contain 200 μg or 600 μg of odevixibat. Capsules have 400 μg or 1200 μg of odevixibat.
How does Bylvay (odevixibat) work?
PFIC is a rare disease that starts early in life. It causes liver damage that gets worse over time. This can lead to liver failure.
In children with PFIC, the liver can’t drain bile properly. This causes toxins to build up in the body. Untreated PFIC can cause severe itching and liver failure.
Odevixibat, in Bylvay, blocks the ileal bile acid transporter. This reduces bile acid reabsorption in the small intestine. It helps remove bile acids through the colon, which may slow liver disease.
Where has Bylvay (odevixibat) been approved?
Bylvay (odevixibat) was approved for PFIC treatment by:
- The European Medicines Agency (EMA), on July 19, 2021.
- The Food and Drug Administration (FDA), USA on July 20, 2021.
It’s the first approved treatment for all PFIC subtypes.
Bylvay also got Orphan Drug designations for Alagille syndrome, biliary atresia, and primary biliary cholangitis by the FDA.
This medicine might be approved in other regions too. If you have questions about its approval in a specific country, contact our support team.
How is Bylvay (odevixibat) taken?
The standard dosage is:
- 40 μg/kg once daily in the morning with a meal.
- If there’s no improvement in pruritus after 3 months, the dosage may increase in steps of 40 μg/kg. The maximum is 120 μg/kg once daily, not exceeding 6 mg daily.
It can be taken as a capsule for older children or as oral pellets sprinkled on food.
Patients taking bile acid binding resins should take Bylvay at least 4 hours before or after these resins.
The treating doctor may adjust the dose, interrupt, or stop treatment if certain side effects occur.
For full information on dosage and administration, see the official prescribing information in our references section.
Note: Please consult with your treating doctor for personalized dosing.
Are there any known adverse reactions or side effects of Bylvay (odevixibat)?
Common adverse reactions
The most common side effects ( ≥2% of patients) include:
- liver test abnormalities
- diarrhea
- abdominal pain
- vomiting
- fat-soluble vitamin deficiency
Serious adverse reactions
No serious side effects were reported in any study with Bylvay (odevixibat).
Use in a specific population
It’s not clear if Bylvay (odevixibat) can harm a fetus. Animal studies suggest it might cause heart problems if a fetus is exposed during pregnancy.
It’s also unknown if Bylvay (odevixibat) gets into breast milk. To avoid any issues, it’s best to stop breastfeeding during treatment and for a month after.
For a full list of side effects and reactions, please see the official prescribing information.
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