Bylvay, illustration of capsule form (not a photo of the actual pack)

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Bylvay

Odevixibat

Prescription required

$6945.00

200MCG · 30 capsules

BrandBranded medicine· By Ipsen

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About Bylvay

Overview

Bylvay capsules contain odevixibat, an ileal bile acid transporter (IBAT) inhibitor. It treats itching in patients aged 3 months and older with progressive familial intrahepatic cholestasis (PFIC), and itching related to impaired bile flow in patients aged 12 months and older with Alagille syndrome. It reduces the reabsorption of bile acids from the intestine, although exactly how this relieves itching is not fully understood. Bylvay is not recommended for certain patients with PFIC type 2 whose ABCB11 gene variants result in a missing or non-functioning bile salt export pump protein.

What it treats

- Itching in patients aged 3 months and older with progressive familial intrahepatic cholestasis (PFIC). Not recommended for certain patients with PFIC type 2 whose ABCB11 gene variants cause the bile salt export pump protein to be absent or non-functional. - Itching due to cholestasis in patients aged 12 months and older with Alagille syndrome (ALGS).

Safety information

Side effects

Common side effects reported in people with PFIC include abnormal liver tests, diarrhea, abdominal pain, vomiting and low levels of fat-soluble vitamins. In people with ALGS, common side effects include diarrhea, abdominal pain, hematoma (a collection of blood under the skin) and weight loss. Bylvay can cause liver injury and fat-soluble vitamin deficiency. Contact your doctor promptly if you develop persistent diarrhea, dehydration, bleeding, a fracture or signs of liver problems. Liver tests and vitamin levels need checking before and during treatment, with frequent liver monitoring during the first 6 to 8 months. Your doctor may need to interrupt or stop treatment if serious problems occur.

When to call your doctor

- Seek medical attention right away for diarrhea that does not stop or dehydration. - Seek medical attention right away for unusual bleeding or a swelling filled with blood under the skin. - Seek medical attention right away if you suspect a broken bone.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not take Bylvay if you have or have previously had hepatic decompensation, when the liver can no longer function adequately. Examples include bleeding from enlarged veins (variceal hemorrhage), fluid buildup in the abdomen (ascites), or brain dysfunction caused by liver disease (hepatic encephalopathy). Bylvay can cause liver injury. Liver tests are needed before treatment, frequently during the first 6 to 8 months, and as clinically indicated afterward. People with compensated cirrhosis or high pressure in the portal vein need more frequent monitoring. Persistent or recurring liver test abnormalities may require treatment to be stopped. Bylvay must be permanently stopped if hepatic decompensation occurs. Persistent diarrhea may require treatment interruption or discontinuation, and dehydration should be treated. Fat-soluble vitamin levels should be checked before and during treatment. Deficiencies may require supplements; persistent or worsening deficiencies despite supplementation may require stopping Bylvay. A fracture may require a treatment interruption. Bleeding requires treatment interruption and management of vitamin deficiency. During pregnancy, Bylvay may cause heart malformations in the unborn baby, based on animal studies.

Using Bylvay

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label BYLVAY (ODEVIXIBAT) CAPSULE, COATED PELLETS [ALBIREO PHARMA, INC.] (DailyMed, retrieved 19 September 2026).

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