Lynavoy (Linerixibat) for Primary Biliary Cholangitis

Lynavoy (linerixibat) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat itching caused by primary biliary cholangitis (PBC) in adults.

How Lynavoy Works and How It’s Taken

Lynavoy is a type of medicine called an ileal bile acid transporter (IBAT) inhibitor. It blocks a protein in the gut that normally reabsorbs bile acids. This helps the body remove more bile acids in stool. Lynavoy may reduce itching in adults with PBC. The exact way it improves itching is not fully known.

Doctors prescribe Lynavoy to treat cholestatic pruritus, which is itching linked to reduced bile flow, in adults with PBC.

Lynavoy comes as a tablet taken by mouth. It should be swallowed whole with water at least 30 minutes before food or any drink other than water.

Typical Dosing for Cholestatic Pruritus Associated With PBC

The recommended dose of Lynavoy is 40 milligrams by mouth two times daily.

A person who also takes a bile acid binding resin should take Lynavoy at least four hours before or four hours after that medicine.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Lynavoy Side Effects

In clinical studies of Lynavoy, the most common side effects occurred in about 6 percent to 62 percent of people. These include:

Diarrhea
Abdominal (stomach) pain
Nausea
Bleeding
Increased liver enzymes (ALT and AST, which can be signs of liver irritation)
Headache
Dyspepsia (upset stomach)
Gastroesophageal reflux disease (GERD, acid reflux)
Abdominal distension (stomach bloating)
Dizziness
Arthralgia (joint pain)

Serious Side Effects and Warnings

Lynavoy can cause serious side effects that may require immediate medical attention. These include:

Liver test elevations — Liver blood tests can rise and may be a sign of liver irritation.
Severe or ongoing diarrhea — This can lead to dehydration, meaning your body loses too much fluid.
Fat-soluble vitamin deficiency — Lynavoy may lower levels of vitamins A, D, E, or K, which can affect bleeding and bone health.
Bleeding — Low vitamin K may cause you to bleed more easily or longer.
Bone fractures — IBAT inhibitor medicines have been linked to broken bones.

Get medical help right away if you think you are having a serious reaction.

How To Save on Lynavoy

Intercept Pharmaceuticals Inc, the manufacturer of Lynavoy, offers Interconnect Support Services. Eligible people with commercial insurance may pay as little as $0 per month.

Interconnect Support Services also offers help understanding insurance coverage, getting started with treatment, and accessing ongoing treatment support and education.

To learn more, visit the Interconnect Support Services website or call 844-622-4278.

What To Know Before Taking Lynavoy

Before starting Lynavoy, your healthcare provider will check:

Liver blood tests, including ALT, AST, total and direct bilirubin, and alkaline phosphatase
Blood levels of vitamins A, D, and E
INR, a blood test related to vitamin K

Tell your doctor if you have any allergies to linerixibat or any ingredients in Lynavoy.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Be sure to tell your healthcare provider if you take a bile acid binding resin, such as cholestyramine or colesevelam. These medicines may reduce the effects of Lynavoy. Take Lynavoy at least four hours before or four hours after a bile acid binding resin.

Do not take Lynavoy if you have a severe liver disease called decompensated cirrhosis. It should also be avoided in people who have or have had liver-related problems such as bleeding from enlarged veins, fluid buildup in the abdomen, or confusion caused by severe liver disease.

If you miss a dose, take it as soon as possible and at least 30 minutes before your next meal. Then return to your regular schedule. If more than six hours have passed, skip the missed dose. Do not take two doses at the same time.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Lynavoy, talk with your doctor about the risks and benefits.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Lynavoy for cholestatic pruritus?

In a 24-week study of adults with PBC and itching, people who took Lynavoy had a greater drop in itch scores than people who took a placebo. The average monthly itch score improved by 2.86 points with Lynavoy and by 2.15 points with placebo. This was a difference of 0.72 points.

People taking Lynavoy also had greater improvement in weekly itch scores by week 2. Sleep problems caused by itching also improved more with Lynavoy. The average monthly sleep score improved by 2.77 points with Lynavoy and by 2.24 points with placebo.

How long does Lynavoy take to work for cholestatic pruritus?

In the main 24-week study, people taking Lynavoy had greater improvement in weekly itch scores by week 2 compared with placebo. The study also showed greater improvement in itching over the full 24 weeks of treatment.

What tests or monitoring are needed with Lynavoy for cholestatic pruritus?

Before starting Lynavoy, your healthcare provider should check several liver blood tests. These include ALT, AST, total bilirubin, direct bilirubin, and alkaline phosphatase.

Your healthcare provider should also check blood levels of vitamins A, D, and E, along with INR. These tests should be monitored during treatment. If new liver test elevations occur, your healthcare provider should check the liver tests more often.