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Ileal bile acid transporter (IBAT) inhibitor

BYLVAY (odevixibat) is a medicine used to treat itching (pruritus) in people with certain rare liver conditions, specifically Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagillle Syndrome (ALGS). It works by blocking a transporter in the intestine to change how bile acids are handled in the body.

How it worksBYLVAY works as an ileal bile acid transporter (IBAT) inhibitor, which helps manage bile acid levels to reduce itching.

Brand names:Bylvay

Used for
Itching caused by Progressive Familial Intrahepatic Cholestasis (PFIC) in patients 3 months of age and older.Itching caused by Alagillle syndrome (ALGS) in patients 12 months of age and older.
Conditions
Progressive Familial Intrahepatic Cholestasis (PFIC)Alagillle Syndrome (ALGS)
Class
IBAT inhibitorIleal bile acid transporter (IBAT) inhibitorHepatic (Liver)Gastrointestinal

How to take

FormsOral pellets, Capsules
RoutesOral

For PFIC, the starting dose is 40 mcg/kg once daily in the morning with a meal. For ALGS, the dose is 120 mcg/kg once daily in the morning with a meal.

Take BYLVAY in the morning with a meal. Do not chew or crush capsules. For the 200 mcg or 600 mcg capsules, the contents should be opened and mixed into soft food or liquids rather than swallowed whole.

Key warnings

  • ·Liver health: You must have liver tests before starting BYLVAY and undergo frequent monitoring for the first 6 to 8 months.
  • ·Vitamin deficiency: BYLVAY can lower levels of fat-soluble vitamins; you may need supplements.
  • ·Diarrhea: Severe diarrhea can occur; treat dehydration and talk to your doctor if it persists.
  • ·Bone health: Low vitamin levels may increase the risk of fractures.

Do not use if

  • ·Do not use BYLVAY if you have had or currently have signs of severe liver failure, such as bleeding from veins in the esophagus, fluid buildup in the belly (ascites), or confusion (hepatic encephalopathy).

Side effects

Common

DiarrheaAbdominal painVomitingLiver test abnormalitiesFat-soluble vitamin deficiency

Serious

  • ·Liver damage (hepatotoxicity)
  • ·Severe diarrhea leading to dehydration
  • ·Fat-soluble vitamin deficiency
  • ·Bone fractures
  • ·Bleeding

Seek help if

  • ·Signs of clinical hepatitis
  • ·Persistent diarrhea
  • ·Signs of hepatic decompensation (e.g., swelling, confusion, bleeding)

Interactions

  • ·Bile acid binding resins (like cholestyrame or colesevlam) should be taken at least 4 hours before or 4 hours after BYLVAY, as they can stop the medicine from working properly.
FoodTake BYLVAY in the morning with a meal.

Special populations

PregnancyAnimal studies suggest BYLVAY may cause heart defects in a developing fetus. Because it can also lower fat-soluble vitamins needed for fetal growth, pregnant patients should be closely monitored.

PediatricBYLVAY is approved for PFIC in children as young as 3 months old and for ALGS in children as young as 12 months old. It has not been proven safe for infants under 3 months (PFIC) or under 12 months (ALGS).

GeriatricBYLVAY has not been studied in adults aged 65 and older, as these liver conditions mostly affect children and young adults.

Talk to your doctor

Monitor

  • ·Liver function tests
  • ·Fat-soluble vitamin levels
  • ·Symptoms of dehydration
  • ·Signs of hepatic decompensation

Questions to ask

  • ·What are my baseline liver test results?
  • ·Do I need fat-soluble vitamin supplements?
  • ·How often will I need liver monitoring?
  • ·What should I do if I experience severe diarrhea?

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-26.