Cholestatic pruritus is a type of itching that can affect people with a liver condition called primary biliary cholangitis (PBC). It is often described as an internal itch that cannot be relieved by scratching. It can have a major impact on daily life, sleep, and overall well-being.
PBC most often affects females between the ages of 30 and 60. It is an autoimmune condition in which the immune system attacks the small tubes (ducts) that carry bile in the liver. Over time, this leads to inflammation and damage to the bile ducts, causing bile acids to build up in the body. Although PBC may not cause symptoms at first, the buildup of bile acids is thought to play a role in itching.
Lynavoy (linerixibat) is a medicine used to treat itching caused by PBC in adults. It is the first medicine approved by the FDA specifically for this purpose.
This article explains how Lynavoy works, how it was studied, and what to expect during treatment.
How Does Lynavoy Work for Cholestatic Pruritus?
Bile is a yellow fluid that contains bile acids, which help your body digest food. After bile acids are released into the intestine, they are usually taken back (reabsorbed) and reused by the body.
Lynavoy works in the digestive system, mainly in the small intestine. It blocks a protein called the ileal bile acid transporter (IBAT), which normally helps reabsorb bile acids back into the body.
When this protein is blocked, more bile acids are passed out in your stool instead of being recycled. This helps lower the overall level of bile acids in the body.
Because a buildup of bile acids is thought to contribute to itching in people with PBC, reducing these levels may help ease symptoms.
How Do I Take Lynavoy?
Lynavoy comes as a tablet that you swallow. The recommended dosage is one 40-milligram (mg) tablet taken by mouth two times each day.
You should take Lynavoy at least 30 minutes before food or drinks (other than water). Aim to take it around the same time each day. An example dosage schedule for Lynavoy may look like one tablet in the morning and one tablet in the evening.
You may need to plan your Lynavoy dose timing carefully if you also take a type of medicine called a bile acid-binding resin, also known as a bile acid sequestrant. Examples include cholestyramine (Prevalite), colesevelam (Welchol), and colestipol (Colestid). If you take one of these medicines, you should take Lynavoy at least four hours before or four hours after it. This spacing helps prevent the bile acid-binding resin from interfering with how Lynavoy works. Your health care provider can help adjust the timing based on your routine and how your medicines are prescribed.
How Was Lynavoy Studied for Cholestatic Pruritus?
Lynavoy was studied in a clinical trial called GLISTEN. The study included 238 adults who had primary biliary cholangitis (PBC) along with moderate-to-severe itching. To enter the study, participants had to have a certain level of itching before the study began, based on a standardized scoring system.
Most participants were female (about 95%), and many were taking other medicines for PBC. Nearly all were taking ursodeoxycholic acid (UDCA), and about half were also using other medicines for itching. At the start of the study, participants had the following characteristics:
- The average age was about 56 years, with a range of 30 to 80 years.
- About 62% were White, 30% were Asian, 3% were American Indian/Alaska Native, and less than 1% were Black; 23% identified as Hispanic or Latino.
- The average itch score was about 7.3 out of 10.
- About half had moderate itching, and about half had severe itching.
- Participants had been living with PBC for an average of six to seven years.
- About 11% had early-stage (compensated) cirrhosis.
Participants were randomly assigned to take either Lynavoy 40 mg two times each day or a placebo (a tablet with no active medicine). Neither the participants nor the researchers knew who was receiving which treatment during the study.
The main goal was to see how much itching improved over 24 weeks. To do this, participants rated how bad their itching was twice a day. They used a scale from 0 to 10, where 0 meant no itching and 10 meant the worst itching imaginable. Each day, the higher of the two scores was used as that day’s worst itch score. Daily scores were averaged over a week to get a weekly score, and the worst weekly score within a four-week period was used as the monthly itch score.
The study also looked at other changes, such as how quickly itching improved, how itching affected sleep, and the number of people who had big improvements in their symptoms. The study also monitored safety by tracking side effects and changes in lab tests.
What Are the Benefits of Lynavoy Based on Studies?
The GLISTEN study showed that Lynavoy worked better than a placebo for treating itching in adults with PBC.
After 24 weeks, people taking Lynavoy had a greater reduction in monthly itch scores than those taking a placebo. On average, itch scores improved by about 2.86 points with Lynavoy, compared with about 2.15 points with placebo.
Other potential benefits of Lynavoy, based on the study results, include:
Early improvement in itching. Lynavoy began to work relatively quickly. Improvements in itching were seen as early as two weeks after starting treatment, with greater reductions compared with placebo.
Better sleep. Because itching can interfere with sleep, the study also measured sleep disruption. People taking Lynavoy reported greater improvements in sleep than those taking a placebo over the 24-week period.
Meaningful symptom relief. More people taking Lynavoy achieved larger reductions in itch scores (a 3-point or greater decrease), which is considered a meaningful improvement for many patients.
Overall, the results show that Lynavoy can reduce itching in some people with PBC. Your results may differ from what was seen in studies.
How Fast Does Lynavoy Start to Work? Does It Keep Working Over Time?
Based on what was seen in study participants, some people may notice improvement within two weeks after starting Lynavoy.
Improvements in itching were maintained throughout the 24-week treatment period. In a follow-up portion of the study, people who switched from placebo to Lynavoy had improvement in their symptoms, while those who stopped Lynavoy tended to have worse itching.
These findings suggest that continuing to take Lynavoy can provide early and long-lasting relief from itching related to PBC. Individual results may vary.
What Can I Do to Prevent or Manage Side Effects of Lynavoy?
Like other medicines, Lynavoy can cause side effects. Not everyone will have the same side effects. Here are some important Lynavoy side effects to watch for and what you can do to help prevent or manage them:
Digestive side effects. Diarrhea is the most common side effect of Lynavoy and can sometimes be serious. In studies, 62% of people taking Lynavoy reported diarrhea and frequent bowel movements. Diarrhea may lead to dehydration. Drink enough fluids and watch for signs of dehydration, such as thirst, dry mouth, peeing less often, or headache. Contact a health care provider if diarrhea does not go away. They may tell you to pause or stop taking Lynavoy if symptoms are severe or persistent.
Stomach pain, nausea, bloating, and upset stomach were also reported in studies. Eating smaller meals and avoiding foods that worsen symptoms may help. Let a health care provider know if symptoms interfere with eating or daily activities.
Liver test changes. Lynavoy may cause your liver enzymes to increase. Your prescriber will order blood tests to check your liver health before starting Lynavoy and during treatment. If your liver enzymes get too high or do not improve, treatment may need to be stopped.
Low vitamin levels. Lynavoy can reduce how well your body absorbs certain vitamins, including vitamins A, D, E, and K. These are called fat-soluble vitamins and are important for normal body functions. Your health care provider will check your vitamin levels before and during treatment and may recommend supplements if needed.
Low levels of these vitamins, especially vitamin K, can increase the risk of bleeding. You may bruise more easily or bleed longer than usual. Contact a health care provider if you notice unusual bleeding, such as nosebleeds, bleeding gums, unusual vaginal bleeding, or blood in your stool.
Low vitamin D levels may affect bone health over time and may raise the risk of bone fractures. While taking Lynavoy, your health care provider may monitor your bone health and make sure your vitamin levels stay in a healthy range. If you have a fall, bone pain, or a possible fracture, seek medical care.
Dizziness, headache, joint pain. If you feel dizzy, sit or lie down right away and stand up slowly. Drinking plenty of fluids may help with headaches. For head or joint pain, ask your health care provider about an over-the-counter pain reliever that is safe for you, if needed.
This is not a complete list of possible Lynavoy side effects. Contact your health care provider if you have symptoms that concern you or do not go away while taking Lynavoy.
