Prescribing guide
Lynavoy (linerixibat)Dosing, baseline liver and fat-soluble vitamin testing, diarrhea and bleeding guidance, and prior authorization criteria for cholestatic pruritus in PBCFor prescribers and their offices treating primary biliary cholangitis (PBC): what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS; baseline ALT, AST, total and direct bilirubin and ALP, serum vitamins A, D and E and INR, a check for decompensated cirrhosis or prior decompensation events, the signed Interconnect enrollment packet, prior authorization, and routing to PANTHERx Rare, the exclusive specialty pharmacy.
Example PA threshold
Cigna example: age 18 or older, PBC by 2 of 3 criteria, ursodiol unless intolerant, moderate to severe pruritus, at least one systemic antipruritic tried unless contraindicated, no hepatic decompensation, a liver specialist; 6 months, then 1 year on response.
Monitoring
Liver tests at baseline and per standard PBC practice, more often after a new elevation; vitamins A, D and E and INR at baseline and periodically; dehydration with diarrhea; bleeding; bone health.
Support line
Interconnect Support Services, 1-844-622-4278, fax 1-833-636-1742, weekdays 8 AM to 8 PM Eastern; co-pay to $0 for commercial plans up to $10,000 a calendar year; PANTHERx Rare Pharmacy, 1-866-347-0951, fax 1-877-912-0734, for dispensing, PA support and appeals.
Give your patient their plan
A one-page handout for starting Lynavoy, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/lynavoyBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Baseline liver tests | The label asks for ALT, AST, total bilirubin, direct bilirubin and ALP before initiating treatment. In GLISTEN, liver test elevations occurred in 14% on Lynavoy against 6% on placebo. | FDA label |
| Baseline vitamins and INR | The label asks for serum vitamins A, D and E and an INR before initiation, because Lynavoy may adversely affect absorption of fat-soluble vitamins A, D, E and K. | FDA label |
| Exclude decompensation | Limitation of use: avoid in decompensated cirrhosis or with prior or active hepatic decompensation events, such as variceal hemorrhage, ascites or hepatic encephalopathy. Efficacy and safety have not been evaluated in Child-Pugh B and C with decompensation. | FDA label |
| Medication reconciliation | Bile acid binding resins are the one labeled interaction; Lynavoy is given at least 4 hours before or 4 hours after a resin. | FDA label |
| Send the prescription to PANTHERx Rare | Intercept's prescriber site says to send Lynavoy prescriptions directly to PANTHERx Rare Pharmacy, phone 1-866-347-0951, fax 1-877-912-0734. Its RareCARE team provides dispensing, clinical support, PA support, appeals and fulfillment. | Lynavoy prescriber support |
| Enroll the patient in Interconnect | The office completes an enrollment packet that includes the prescription, with HIPAA, patient consent and program services opt-in forms. The patient must sign before fulfillment begins. Interconnect phone 1-844-622-4278, fax 1-833-636-1742. | Interconnect, what to expect |
| Prior authorization | Cigna recommends PA and requires the drug to be prescribed by or in consultation with a gastroenterologist, hepatologist or liver transplant physician. Initial approval is 6 months. | Cigna policy |
Prior authorization criteria and what to document
One public policy as the example: Cigna, April 15, 2026. Approval 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age | 18 or older | Date of birth on the request | Cigna policy |
| Diagnosis | PBC by 2 of 3: ALP above the upper limit of normal; AMA, or sp100 or gp210 if AMA negative; histologic evidence from a liver biopsy | ALP with reference range, antibody results, pathology report if done | Cigna policy |
| Ursodiol | According to the prescriber, the patient is receiving ursodiol therapy, unless intolerant | Ursodiol dose and start date, or the intolerance noted | Cigna policy |
| Pruritus severity | According to the prescriber, moderate to severe pruritus | A statement in the note; an itch score if the office records one | Cigna policy |
| Prior antipruritic | At least one systemic medication for cholestatic pruritus tried, unless contraindicated; the policy lists cholestyramine, rifampicin, naltrexone, sertraline and fenofibrate | Agent, dates and outcome, or the contraindication | Cigna policy |
| Decompensation | No current or past hepatic decompensation event, such as ascites, gastroesophageal varices, variceal bleeding, hepatic encephalopathy or coagulopathy | A statement in the note; imaging or endoscopy where relevant | Cigna policy |
| Prescriber | Prescribed by or in consultation with a gastroenterologist, hepatologist or liver transplant physician | Specialty on the request, or the consult note | Cigna policy |
| Renewal | 1 year if there is still no decompensation and the prescriber reports a response, such as decreased pruritus, reduced pruritus-related sleep interference or improved ALP or bilirubin | Current itch assessment and labs against the pretreatment values | Cigna policy |
| Not covered | Concomitant use with Iqirvo (elafibranor) or Livdelzi (seladelpar); the policy cites no data on the combinations | Medication list on the request | Cigna policy |
Lynavoy dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 40mg orally twice daily, swallowed whole at least 30 minutes before any food or beverage other than water. One strength, no titration. A bottle holds 60 tablets, a 30-day supply. | FDA label |
| Why before food | Food does not change exposure in a clinically significant way. The label sets the timing so that linerixibat enters the gastrointestinal lumen before bile acids are released on eating. | FDA label |
| Missed dose | Take as soon as possible and at least 30 minutes before the next meal, then resume the schedule. If missed by more than 6 hours, skip it. No double dose. | FDA label |
| Bile acid binding resins | Give Lynavoy at least 4 hours before or 4 hours after the resin. | FDA label |
| Renal and hepatic impairment | Same dose in renal impairment; not studied in severe renal impairment (eGFR below 30) or hemodialysis. Same dose in Child-Pugh A. Avoid in decompensated cirrhosis or with prior or active decompensation events. | FDA label |
| Age 65 and older | No overall differences in safety or effectiveness between patients 65 to under 75 and younger adults; too few patients 75 and older to judge. | FDA label |
| Overdose | No specific antidote. GI adverse reactions rose with dose at 4.5 times the recommended dosage. Discontinue, monitor and give supportive care; Poison Help is 1-800-222-1222. | FDA label |
| Label version | The June 2026 revision differs from the March 2026 approved text in the company (Intercept in place of GlaxoSmithKline), the reporting number (1-844-782-4278 in place of 1-888-825-5249) and the NDC (69516-140-60 in place of 0173-0938-18). Dose, indication and warnings read the same. | March 2026 label |
Monitoring the Lynavoy label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | ALT, AST, total bilirubin, direct bilirubin, ALP | Required by the label before initiation | FDA label |
| Baseline | Serum vitamins A, D and E, and INR | Required by the label before initiation; supplement if deficiency is diagnosed | FDA label |
| During treatment | ALT, AST, total bilirubin, direct bilirubin, ALP | Per standard clinical practice for PBC; more frequently after a new elevation; discontinue if elevations persist. Elevations 14% against 6%, discontinuations for them 5% against 2%; ALT above 3 times baseline 7% against 3%, total bilirubin above 2 times baseline 8% against 3% | FDA label |
| Periodically | Vitamins A, D and E, INR, and clinical signs of deficiency | Supplement if deficient; consider discontinuing if deficiency persists or worsens despite adequate supplementation. Deficiency reported in 2% against under 1% over 24 weeks | FDA label |
| First 20 days | Diarrhea | 62% against 18%; 76% of affected Lynavoy patients had onset within 20 days; 62% mild, 34% moderate, 4% severe. Advise monitoring for dehydration; consider interrupting or discontinuing if it persists | FDA label |
| Any time | Bleeding | Hemorrhage events 9% against 3%. Interrupt, evaluate for fat-soluble vitamin deficiency; restart is allowed once deficiency is corrected, levels are maintained and bleeding has resolved | FDA label |
| During treatment | Bone health | IBAT inhibitors have been associated with fractures; monitor bone health and ensure adequate fat-soluble vitamin levels | FDA label |
| Any time | Abdominal pain | 26% against 10%; with diarrhea and ALT and AST increases, among the most common causes of discontinuation, which totaled 14% against 5%. The label gives no specific action for it | FDA label |
| Pregnancy and lactation | Fat-soluble vitamin status | No human pregnancy data; minimal fetal exposure expected. Monitor for deficiency and supplement; report exposure to Intercept at 1-844-782-4278 | FDA label |
| Postmarketing | FDA-required studies | A pregnancy outcomes study, final report due September 2037, and completion of the LLSAT long-term safety trial on liver injury, bone health and bleeding, final report due March 2027 | FDA letter |
Lynavoy drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Bile acid binding resins | May bind linerixibat in the gut and inhibit its effect on IBAT; 78% to 95% bound to cholestyramine and colesevelam in vitro. Separate by at least 4 hours | FDA label |
| UDCA | No effect on UDCA plasma concentrations in a 12-week dose-ranging study; glyco-UDCA and tauro-UDCA fell 69% and 90%, with no clinically significant ALP increase. In GLISTEN, 97% of patients were on UDCA | FDA label |
| CYP and transporters | In vitro inhibitor of CYP3A4 and potential inhibitor of OATP1B1 and OATP1B3; the label calls an interaction not likely because of the low fraction absorbed (oral bioavailability 0.05%) | FDA label |
| Antipruritics other than resins | No labeled interaction; 47% of GLISTEN patients were on concomitant antipruritic drugs at baseline | FDA label |
| Hepatic impairment | In Child-Pugh B, AUC about 13-fold and Cmax about 9.4-fold higher than matched healthy subjects, significance unknown; not studied in Child-Pugh C. Avoid with decompensation | FDA label |
| Iqirvo or Livdelzi | Not a label interaction. Cigna's policy treats concomitant use with either as not medically necessary | Cigna policy |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Interconnect Support Services
- 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
Questions prescribers' offices ask about Lynavoy
What is the Lynavoy dose?
The label revised June 2026 gives 40mg orally twice daily, swallowed whole at least 30 minutes before any food or beverage other than water. There is one strength and no titration. The dose is unchanged in renal impairment and in Child-Pugh A, and bile acid binding resins are separated by at least 4 hours.
What baseline tests does the Lynavoy label require?
The label revised June 2026 asks for 5 liver tests (ALT, AST, total bilirubin, direct bilirubin and ALP) plus serum vitamins A, D and E and an INR before initiation. Liver tests are then monitored per standard clinical practice for PBC, and the vitamin levels and INR periodically, with no fixed interval.
How common is diarrhea on Lynavoy, and what does the label say to do?
Diarrhea occurred in 62% of patients on Lynavoy against 18% on placebo in GLISTEN, per the label revised June 2026. Of those affected on Lynavoy, 76% had onset within the first 20 days; 62% of cases were mild, 34% moderate and 4% severe, and 4% of patients discontinued for it. The label says to advise patients to monitor for dehydration and to consider interrupting or discontinuing if diarrhea persists.
When does the label say to interrupt or stop Lynavoy?
The label revised June 2026 names 4 situations. Discontinue for persistent liver test elevations. Consider interrupting or discontinuing for persistent diarrhea. Interrupt for bleeding and evaluate for fat-soluble vitamin deficiency, with restart allowed once the deficiency is corrected, levels are maintained and bleeding has resolved. Consider discontinuing if vitamin deficiency persists or worsens despite adequate supplementation.
What do insurers ask for to approve Lynavoy?
The Cigna policy shown on this page, a new policy reviewed April 15, 2026, asks for age 18 or older and PBC by 2 of 3 diagnostic criteria. It also requires ursodiol unless intolerant, moderate to severe pruritus, a trial of at least one systemic antipruritic unless contraindicated, no hepatic decompensation, and a gastroenterologist, hepatologist or transplant physician. It approves 6 months, then 1 year, and cites the March 2026 GlaxoSmithKline label.
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Sources
- LYNAVOY (linerixibat) tablets prescribing information and Patient Information, revised June 2026, Intercept Pharmaceuticals, via DailyMed and openFDA, 2026-07-29.
- NDA 220295 approval letter, Lynavoy (linerixibat) tablets, FDA, 2026-03-17.
- LYNAVOY (linerixibat) tablets prescribing information and Patient Information as first approved, revised March 2026, GlaxoSmithKline, via FDA Drugs@FDA, 2026-03-17.
- Drugs@FDA record for NDA 220295, LYNAVOY, read through openFDA, FDA, 2026-11-13.
- LYNAVOY (linerixibat) | Access support, Intercept Pharmaceuticals, 2026-11-13.
- Coverage Assistance | Interconnect Support Services, Intercept Pharmaceuticals, 2026-11-13.
- What to Expect | Interconnect Support Services, Intercept Pharmaceuticals, 2026-11-13.
- Interconnect Savings Program Terms and Conditions, Intercept Pharmaceuticals, 2026-11-13.
- LYNAVOY | Support, Intercept Pharmaceuticals, 2026-11-13.
- Cigna National Formulary Coverage, Hepatology, Lynavoy Prior Authorization Policy, Cigna, 2026-04-15.
A reference drawn from the July 29, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 13, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.