What Is Lynavoy, and Why Does It Matter?
Lynavoy (linerixibat) is a prescription pill approved by the FDA for treating cholestatic pruritus, a severe, chronic (long-standing), internal (felt under the skin) itch in adults with primary biliary cholangitis (PBC).
PBC is a rare autoimmune liver disease in which the outflow of bile from the liver is affected, leading to the buildup of bile acids in the body, which can trigger severe internal itching (pruritus) that is not relieved by scratching. Up to 89% of people with PBC have this cholestatic itch, which can appear at any stage of the disease. This unique itch is more than a mere discomfort, as it can ruin your sleep, cause fatigue, and lower your quality of life. In extreme cases, it may require a liver transplant even without liver failure.
Lynavoy is an ileal bile acid transporter (IBAT) inhibitor that works in your gut by blocking the protein IBAT, which normally helps reabsorb bile acids back into your body. By selectively blocking IBAT, Lynavoy allows more bile acids to pass out of your body through stools. This lowers the overall bile acid levels in your system, which can ease cholestatic itch and improve your sleep and daily life.
This approval matters because until now, cholestatic itch had limited therapeutic options. Lynavoy is the first oral medicine in the U.S. cleared specifically to target key pathways causing cholestatic itch in PBC, offering a novel option for a symptom that can disrupt daily life and overall well-being.
Why Was It Approved?
This FDA approval is based on positive results from a clinical study that showed that Lynavoy is effective in providing significant, quick, and lasting reduction in itching and improved sleep in patients with PBC and cholestatic pruritus.
The phase 3 study included 238 patients with a confirmed diagnosis of PBC and presence of cholestatic pruritus. The patients were randomly selected to receive either Lynavoy or a placebo by mouth twice a day. The results showed that compared with a placebo, Lynavoy provided significant and rapid relief from itching, with improvements seen as early as two weeks and maintained over 24 weeks. Patients taking Lynavoy showed a greater reduction in itch scores and improvement in itch-related sleep disturbances.
The most common side effects usually are mild to moderate diarrhea and belly pain, stomach bloating, gastroesophageal reflux disease (GERD, or chronic acid reflux), dizziness, and joint pain. It can also cause serious side effects such as elevated levels of liver enzymes, severe diarrhea, and dehydration. Lynavoy may also cause fat-soluble vitamin deficiency due to low levels of vitamins A, D, E, and K stored in body fat, leading to easy or prolonged bleeding and a higher risk of bone fractures.
What Do I Need to Know?
Lynavoy is taken by mouth twice a day. Swallow the tablets whole, and wait at least half an hour before you eat or drink anything except water. If you miss a dose of Lynavoy, take it as soon as you remember, at least half an hour before your next meal. If more than six hours have passed, skip it and take your next dose at the usual time. Do not combine two doses to make up for the one you missed.
Before starting and during your treatment, your health care provider will do certain blood tests to check your liver enzyme levels; measure vitamin A, D, E, and K levels to check for fat‑soluble vitamin deficiency; and perform a blood clotting test called the international normalized ratio. Your health care provider may also monitor your bone health during the treatment.
Your health care provider may pause or stop Lynavoy if your liver test results are not normal, you have bleeding, or you have severe diarrhea that does not improve. If any vitamin deficiency is found, your health care provider will prescribe supplements for you. You can restart Lynavoy once vitamin levels are corrected and bleeding has resolved.
Let your health care provider know about your health conditions, especially if you have severe liver disease (decompensated cirrhosis), serious liver-related problems such as bleeding of enlarged blood vessels in the stomach area (variceal hemorrhage) or fluid buildup in the belly area (ascites), or brain-related symptoms like confusion or trouble speaking (hepatic encephalopathy) caused by liver disease.
Also, tell your provider about all the medicines you take – including prescription and over-the-counter drugs, vitamins, and health supplements – as Lynavoy may interact with other medicines. If you're also on a bile acid-binding resin (cholestyramine or colesevelam), take it at least four hours before or four hours after taking Lynavoy, as taking them together may reduce the effects of Lynavoy.
Before taking Lynavoy, tell your health care provider if you are pregnant, planning to become pregnant, or breastfeeding. It is not known if the medicine can harm a fetus or pass into breast milk, so your doctor can help you decide what's safest.
Contact your health care provider right away if you notice any signs of dehydration such as thirst, dry mouth, passing low amounts of urine or urinating less frequently, a headache, or diarrhea that does not go away; bleeding problems; or a bone fracture. These could be signs of serious side effects.