Your first 90 days
Your first 90 days on Lynavoy for the itch of primary biliary cholangitis (PBC)
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Lynavoy is approved for one thing, the itch that comes with primary biliary cholangitis, which doctors call cholestatic pruritus. No REMS form and no boxed warning stand between the prescription and the first fill. What the label does ask for is a set of blood tests before day 1, covering the liver, 3 vitamins and clotting. After that the routine is one tablet morning and evening, each at least 30 minutes before food. Diarrhea was common in the trial and mostly began in the first 20 days. GSK developed Lynavoy, and Intercept Pharmaceuticals, part of Alfasigma, now supplies it in the US. This page lays out the first 3 months from the FDA label, Intercept's Interconnect program and one insurer's written rules.
What has to happen before the first bottle ships
Lynavoy has no REMS, so the first fill waits on baseline blood tests, a signed enrollment form, an insurance approval and one specialty pharmacy. These are the 7 things in the way, in order.
Liver blood tests before day 1
The label asks the prescriber to get baseline liver tests before starting Lynavoy.
- It names ALT, AST, total bilirubin, direct bilirubin and alkaline phosphatase (ALP).
- In the main trial, liver test increases were more common on Lynavoy than on placebo.FDA label
Vitamin levels and a clotting test
Lynavoy may lower absorption of the fat-soluble vitamins A, D, E and K, according to the label.
- It asks for blood levels of vitamins A, D and E and an INR before the first dose.
- The INR is a clotting test that stands in for vitamin K.FDA label
A check for advanced liver disease
The label says to avoid Lynavoy in people with decompensated cirrhosis.
- The same applies to anyone who has or has had bleeding from swollen veins, fluid in the belly or hepatic encephalopathy.
- Hepatic encephalopathy means confusion, slurred speech or sluggish movements caused by severe liver disease.FDA label
A full medicine list
The Patient Information asks you to list every prescription, over-the-counter medicine, vitamin and herbal supplement.
- It singles out bile acid binding resins such as cholestyramine and colesevelam, which may reduce the effects of Lynavoy.FDA label
The Interconnect enrollment forms
Interconnect says your doctor fills out an enrollment packet with HIPAA, patient consent and program opt-in forms.
- You must sign these forms to begin the Lynavoy fulfillment process, and you can sign them at the doctor's office.
- A Care Manager then calls you to discuss the details of your prescription.Interconnect, what to expect
The insurance approval
Cigna's written policy recommends prior authorization before it covers Lynavoy.
- It wants moderate to severe itch, ursodiol unless you cannot tolerate it, and at least one other itch medicine already tried.
- It also asks for no current or past liver decompensation, and a gastroenterologist, hepatologist or liver transplant physician involved.Cigna policy
One specialty pharmacy
Interconnect says PANTHERx Rare is the exclusive specialty pharmacy for Lynavoy, and that other specialty pharmacies do not supply it.
- Your medicine can be shipped to your home or your place of work if you ask.Interconnect, what to expect
The days that matter
Counted from the first dose, with blood tests before it, the first 20 days when most diarrhea began, and a refill every 30 days. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Baseline blood tests and a medicine review
Liver tests, vitamin A, D and E levels and an INR, which the label asks for before the first dose.
- Bring a full medicine list, since the label sets a 4-hour gap from bile acid binding resins.
Forms signed, then a Care Manager calls
Your doctor completes the Interconnect enrollment packet, which includes your prescription, and you sign it.
- Once you are enrolled, a Care Manager calls to discuss the details of your prescription and answer questions.
First dose, 40mg morning and evening
One tablet 2 times a day, swallowed whole with some water, at least 30 minutes before any food or drink except water.
- A bottle holds 60 tablets, which is a 30-day supply at this dose.
Two weeks in
In the main trial, the weekly itch score had already improved more on Lynavoy than on placebo at week 2.
- The label reports a difference of 0.71 points at that point, on a scale from 0 to 10.
The first 20 days, when most diarrhea began
Among people who had diarrhea on Lynavoy in the trial, 76% had it start within the first 20 days.
- The Patient Information says to check for signs of dehydration and to call your healthcare provider about diarrhea that does not go away.
Refill ordered about a week ahead
Interconnect says ordering refills about a week before you run out can help the new supply arrive on time.
- Its Care Manager Team can connect you to the specialty pharmacy to schedule deliveries.
Refill, then about every 30 days
A 60-tablet bottle runs out here at 2 tablets a day.
- The label says to store the tablets in the original package, which protects them from moisture.
Refill, number 2
Three months in
The label asks for liver tests during treatment as part of standard care for PBC, without a fixed schedule.
- It asks for vitamin levels and the INR periodically, so the timing is the hepatologist's call.
Refill, number 3
Prior authorization renewal ahead
Under Cigna's policy, the first approval of Lynavoy lasts 6 months.
- Renewal needs the prescriber to report a response, such as less itch or better sleep, and no liver decompensation.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Lynavoy label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated July 29, 2026, read from the FDA's label database today. FDA label
- June 2026
The label was reissued under Intercept Pharmaceuticals, a subsidiary of Alfasigma, in place of GlaxoSmithKline. The side effect and pregnancy reporting number became 1-844-782-4278 and the package code changed. The FDA's record lists no new approval action, and the dose, approved use and warnings read the same as in March.Drugs@FDA record
- March 2026
First approval, on March 17, 2026, for cholestatic pruritus associated with PBC in adults. The FDA required a pregnancy outcomes study and completion of the LLSAT long-term safety trial, which looks at liver injury, bone health and bleeding.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Twice a day, 30 minutes before food or drink
The label gives 40mg by mouth twice daily, at least 30 minutes before any food or beverage other than water.
- It explains that the timing lets the medicine reach the gut before eating releases bile acids.FDA label
- Whole, with some water
The Patient Information says to take 1 tablet in the morning and 1 in the evening.
- It says to swallow each tablet whole with some water.FDA label
- If you miss a dose
The label says to take a missed dose as soon as possible and at least 30 minutes before your next meal.
- If more than 6 hours have passed, it says to skip that dose and take the next one at the regular time.
- It says not to take a double dose to make up for a missed one.FDA label
- Bile acid binding resins
The label says to take Lynavoy at least 4 hours before or 4 hours after a bile acid binding resin.
- Cholestyramine and colesevelam are the examples it names.
- Lab studies found these resins can bind Lynavoy in the gut, which may reduce its effect.FDA label
- Blood tests during treatment
The label asks for liver tests during treatment and more often if a result rises.
- It asks for vitamin A, D and E levels and the INR periodically.
- If a vitamin level is low, the label tells prescribers to add a supplement.FDA label
- Advanced liver disease
The label says to avoid Lynavoy in decompensated cirrhosis or after a decompensation event.
- Its safety and effectiveness have not been evaluated in moderate or severe liver impairment with decompensation.
- In a study of people with moderate liver impairment, blood levels of the drug were about 13 times higher than in healthy volunteers.
- The label says the clinical significance of that increase is unknown.FDA label
- Pregnancy and breastfeeding
The label says there are no data on Lynavoy in pregnant women, and that very little of the drug is absorbed.
- It asks prescribers to watch fat-soluble vitamin levels during pregnancy and breastfeeding.
- A pregnancy safety study collects outcomes, and pregnancies can be reported to Intercept at 1-844-782-4278.FDA label
- Kidney disease
The label gives the same dose for people with kidney impairment, because very little of the drug is absorbed.
- It adds that Lynavoy has not been studied in severe kidney impairment or in people on hemodialysis.FDA label
- Too much Lynavoy
At 4.5 times the recommended dose, stomach and bowel side effects became more frequent in studies.
- The Patient Information says to call your healthcare provider or Poison Help at 1-800-222-1222 after taking too much.
- It also says you can go to the nearest hospital emergency room right away.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit, in the original package with the bottle tightly closed, to protect it from moisture.
- The bottle has a child-resistant cap and holds a drying canister.
- The Patient Information says not to remove or swallow that canister.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Diarrhea and signs of dehydration
Diarrhea occurred in 62% of people on Lynavoy against 18% on placebo.
- Among those who had it on Lynavoy, 62% of cases were mild, 34% moderate and 4% severe.
- The Patient Information lists thirst, dry mouth, urinating less often and headache as signs of dehydration.
- It says to call your healthcare provider if diarrhea does not go away.
- The label lets the prescriber pause or stop Lynavoy for diarrhea that persists.FDA label
Stomach pain
Abdominal pain occurred in 26% of people on Lynavoy against 10% on placebo.
- The label counts pain in the upper or lower belly and abdominal discomfort in that figure.
- It lists abdominal pain among the most common reasons people stopped treatment, and gives no specific step for it.FDA label
Bleeding and broken bones
Bleeding events occurred in 9% of people on Lynavoy against 3% on placebo.
- The label's list includes bruising, nosebleeds, and bleeding from the stomach or bowel.
- The Patient Information says to call your healthcare provider about bleeding problems or a bone fracture.
- The label tells prescribers to pause Lynavoy if bleeding occurs and to check vitamin levels.FDA label
Liver blood tests
Liver test increases occurred in 14% of people on Lynavoy against 6% on placebo.
- Because of them, 5% stopped Lynavoy against 2% on placebo.
- The Patient Information says an increase in liver enzymes can be serious.
- The label tells prescribers to stop Lynavoy if the increases persist.FDA label
Low vitamin levels
Fat-soluble vitamin deficiency was reported in 2% of people on Lynavoy against under 1% on placebo over 24 weeks.
- The Patient Information says people with this deficiency can bleed more easily or longer, or may develop bone fractures.FDA label
Nausea, headache, upset stomach, reflux, bloating, dizziness and joint pain
Nausea occurred in 10% on Lynavoy against 9% on placebo, and headache in 8% against 3%.
- Upset stomach was 8% against under 1%, reflux 7% against 4% and bloating 7% against 5%.
- Dizziness was 6% against 3%, and joint pain 6% against 5%.
- Side effects led 14% of people on Lynavoy to stop, against 5% on placebo.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- Prior authorization pending or deniedPlans ask for the criteria below. Cigna's include moderate to severe itch, ursodiol unless you cannot tolerate it, and one other itch medicine already tried. Cigna also asks for no current or past liver decompensation and a gastroenterologist, hepatologist or liver transplant physician involved. The hepatologist's records usually answer these points.Cigna policy
- Nobody seems to be handling the appealIntercept's prescriber site says PANTHERx's RareCARE team provides prior authorization support, appeals and fulfillment. It lists PANTHERx Rare Pharmacy at 1-866-347-0951, which is a number the prescriber's office can use.Lynavoy prescriber support
- The prescription went to another pharmacyInterconnect says PANTHERx Rare is the exclusive specialty pharmacy for Lynavoy and that other specialty pharmacies do not supply it. The prescriber's office can resend the prescription there. A prescription sent to the wrong pharmacy is a routing problem, not a denial.Interconnect, what to expect
- A copay you cannot payCommercial insurance: the Interconnect Savings Program, as little as $0 a month, up to $10,000 a calendar year. Medicare, Medicaid, Medigap, VA, DoD and TRICARE are excluded by its terms. The terms also say the offer is not valid for Massachusetts residents whose prescriptions are covered, in whole or in part, by third-party insurance.Co-pay terms
- Medicare, Medicaid or no insuranceInterconnect says help may be available through independent foundations for people with Medicare or Medicaid. For people with no insurance or limited coverage for Lynavoy, it says those who qualify may get treatment at no cost. Its Care Manager Team checks eligibility at 1-844-622-4278.Interconnect coverage
- Lynavoy requested with Iqirvo or LivdelziCigna lists use with Iqirvo (elafibranor) or Livdelzi (seladelpar) as not medically necessary, citing no data on the combinations. The hepatologist decides the plan, and the insurer's rule is worth knowing first.Cigna policy
Cigna prior authorization policy, April 15, 2026
- Age 18 or older
- Primary biliary cholangitis shown by 2 of these: a raised ALP, anti-mitochondrial or other PBC-specific antibodies, or a liver biopsy
- Taking ursodiol, unless it cannot be tolerated, according to the prescriber
- Moderate to severe itch, according to the prescriber
- At least one systemic medicine for cholestatic itch already tried, unless contraindicated; the policy lists cholestyramine, rifampicin, naltrexone, sertraline and fenofibrate
- No current or past liver decompensation, such as ascites, varices, variceal bleeding, hepatic encephalopathy or coagulopathy
- Prescribed by or in consultation with a gastroenterologist, hepatologist or liver transplant physician
Approval length. An initial 6 months, then 1 year at a time if the prescriber reports a response, such as less itch or less itch-related sleep loss, and still no decompensation.
Cigna reviewed this as a new policy on April 15, 2026, and it cites the March 2026 prescribing information under GlaxoSmithKline. The June 2026 label revision moved the label to Intercept Pharmaceuticals and changed contact numbers, not the approved use or the dose. It is here as an example of what a plan asks for, not as a rule. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- Care Managers who explain your current benefits, explore coverage assistance options and offer support and education during treatment
- The Interconnect Savings Program for adults with commercial insurance, as little as $0 a month, up to $10,000 a calendar year. It is not valid with Medicare, Medicaid, Medigap, VA, DoD, TRICARE or other federal or state programs. Co-pay terms
- For people with Medicare or Medicaid, a pointer to independent foundations that may be able to help Interconnect coverage
- For people with no insurance or limited coverage for Lynavoy, treatment at no cost for those who qualify Interconnect coverage
- A language line for live support in over 100 languages Interconnect, what to expect
- Delivery through PANTHERx Rare, the exclusive specialty pharmacy, to your home or place of work Interconnect, what to expect
Details as the drugmaker publishes them. Lynavoy support
Five questions for the pharmacist or the support line
- Are you PANTHERx Rare, and what number will your delivery and refill calls come from?
- I take these medicines and supplements. Is any of them a bile acid binding resin, such as cholestyramine or colesevelam?
- What is my cost per bottle after insurance, and has the Interconnect Savings Program been applied?
- How many days before my bottle runs out should I order the next one?
- My bottle has a drying canister inside. Does it stay in the bottle the whole month?
Questions people ask in the first weeks
How long does it take to get Lynavoy after it is prescribed?
No fixed number of days applies to everyone who starts Lynavoy. The baseline blood tests, the signed Interconnect enrollment forms and the prior authorization each take their own time. Interconnect says a Care Manager calls once you are enrolled, and PANTHERx Rare supplies the medicine.
Can I pick up Lynavoy at my regular pharmacy?
Interconnect says PANTHERx Rare is the exclusive specialty pharmacy for Lynavoy, and that other specialty pharmacies do not supply it. It says the medicine can be shipped to your home or place of work.
Does Lynavoy treat PBC itself or only the itch?
The label approves Lynavoy for cholestatic pruritus, the itch associated with PBC, in adults, and lists no other use. In the main trial, 97% of people were also taking ursodiol for their PBC. Which medicines you take for the liver disease itself is the hepatologist's decision.
How soon does Lynavoy help the itch?
In the GLISTEN trial of 238 adults, itch scores had improved more on Lynavoy than on placebo by week 2. Over 24 weeks the monthly itch score fell 2.86 points on Lynavoy and 2.15 on placebo, on a 0 to 10 scale. Itch-related sleep interference fell 2.77 points against 2.24.
How common is diarrhea on Lynavoy?
In the trial, diarrhea occurred in 62% of people on Lynavoy against 18% on placebo. Most cases began in the first 20 days, 62% of them were mild and 34% moderate, and 4% of people stopped because of it. The Patient Information says to call your healthcare provider about diarrhea that does not go away.
What if I miss a dose of Lynavoy?
The label says to take it as soon as possible and at least 30 minutes before your next meal. If more than 6 hours have passed, it says to skip the dose and take the next one at the regular time. It says not to take a double dose.
Does Lynavoy need blood tests?
Yes, by the label, before the first dose and during treatment. The tests are liver tests, blood levels of vitamins A, D and E, and an INR. The label sets no fixed schedule after the first dose, so the hepatologist decides the timing.
Why was Lynavoy denied by my insurance?
Cigna's policy asks for moderate to severe itch, ursodiol unless you cannot tolerate it, and at least one other itch medicine tried first. It also asks for no current or past liver decompensation and a liver or digestive specialist involved. The hepatologist's records of the itch and earlier treatments usually resolve it.
Who makes Lynavoy?
The FDA approved Lynavoy on March 17, 2026 in a letter addressed to GSK, which developed it. The current label says it is made for Intercept Pharmaceuticals, a wholly owned subsidiary of Alfasigma. Intercept runs Interconnect, the support program named on the Lynavoy website.
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Sources
- LYNAVOY (linerixibat) tablets prescribing information and Patient Information, revised June 2026, Intercept Pharmaceuticals, via DailyMed and openFDA, July 29, 2026.
- NDA 220295 approval letter, Lynavoy (linerixibat) tablets, FDA, March 17, 2026.
- LYNAVOY (linerixibat) tablets prescribing information and Patient Information as first approved, revised March 2026, GlaxoSmithKline, via FDA Drugs@FDA, March 17, 2026.
- Drugs@FDA record for NDA 220295, LYNAVOY, read through openFDA, FDA, November 13, 2026.
- LYNAVOY (linerixibat) | Access support, Intercept Pharmaceuticals, November 13, 2026.
- Coverage Assistance | Interconnect Support Services, Intercept Pharmaceuticals, November 13, 2026.
- What to Expect | Interconnect Support Services, Intercept Pharmaceuticals, November 13, 2026.
- Interconnect Savings Program Terms and Conditions, Intercept Pharmaceuticals, November 13, 2026.
- LYNAVOY | Support, Intercept Pharmaceuticals, November 13, 2026.
- Cigna National Formulary Coverage, Hepatology, Lynavoy Prior Authorization Policy, Cigna, April 15, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing hepatologist. Found an error? Use the report link in the footer and it will be checked against the source.