Prescribing guide
Livdelzi (seladelpar)Dosing, liver monitoring, interactions and prior authorization criteria for primary biliary cholangitisFor 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.
Label updated. The FDA's label database lists a Livdelzi label dated February 3, 2026, newer than the January 30, 2026 label this guide is built from. Trial Friend is rechecking this guide; until then the current label governs: current label on DailyMed.
Dispensing gate
No REMS; baseline clinical and laboratory liver assessment, a check for decompensated cirrhosis, a medication review against the interaction table, prior authorization, and routing to a specialty pharmacy in Gilead's network.
Example PA threshold
Cigna example: age 18 or older, PBC by 2 of 3 criteria, ursodiol for at least 1 year with an inadequate response or ursodiol intolerance, no hepatic decompensation, a liver specialist; 6 months, then 1 year on response.
Monitoring
Liver tests at baseline and during treatment per routine management, bone health per standard of care, decompensation in patients with cirrhosis; ALP and bilirubin when rifampin starts.
Support line
Gilead Support Path, 1-855-769-7284 (1-855-7-MYPATH), program navigator for benefits investigation and PA and appeals information, co-pay to $0 for commercial plans up to $10,000 a year, Patient Assistance Program for eligible uninsured, Field Reimbursement Manager on request.
Give your patient their plan
A one-page handout for starting Livdelzi, 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/livdelziBefore 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 assessment | The label asks for baseline clinical and laboratory liver assessments at initiation. ALT, AST, total bilirubin and ALP are the tests it names for interruption decisions. | FDA label |
| Exclude decompensated cirrhosis | Not recommended in patients who have or develop decompensated cirrhosis, such as ascites, variceal bleeding or hepatic encephalopathy. Safety and efficacy there have not been established. Avoid in complete biliary obstruction. | FDA label |
| Medication reconciliation | Probenecid is to be avoided; strong CYP2C9 inhibitors, fluconazole-type dual inhibitors, cyclosporine-type transporter inhibitors and rifampin each call for monitoring. Bile acid sequestrants are separated by at least 4 hours. | FDA label |
| Prior authorization | Cigna requires PA and a gastroenterologist, hepatologist or liver transplant physician as prescriber or consultant. It also requires at least 1 year of ursodiol with an inadequate response or intolerance, and no current or past hepatic decompensation. | Cigna policy |
| Route to a specialty pharmacy | Gilead lists Orsini, (888) 263-8004, PANTHERx Rare, (888) 685-1482, and Acaria Health, (833) 236-9722, plus the specialty distributor CuraScript SD, (877) 599-7748; the list is subject to change. The pharmacy explains coverage, assists with the PA, confirms cost and calls the patient for delivery and each refill. | Livdelzi ordering |
| Gilead Support Path | A program navigator offers benefits investigation, PA and appeals information and the Patient Assistance Program for eligible uninsured patients; the office can request a Field Reimbursement Manager at 1-855-769-7284. | Gilead Support Path |
Prior authorization criteria and what to document
One public policy as the example: Cigna, August 1, 2026. Approval an initial 6 months, then 1 year at a time if the prescriber reports a response, such as better ALP, and still no decompensation. This policy was reviewed on June 18, 2026 and took effect on August 1, 2026, yet it still cites the August 2024 prescribing information. The January 2026 label revision changed the interaction and pharmacokinetic sections, not the approved use. 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; histology from a liver biopsy | ALP with reference range, antibody results, pathology report if done | Cigna policy |
| Prior therapy | Ursodiol for at least 1 year with an inadequate response according to the prescriber, or ursodiol intolerance | Ursodiol start date, dose, ALP and bilirubin trend, or the intolerance noted | 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 | Response to therapy as determined by the prescriber, such as improved ALP, bilirubin, GGT, AST or ALT, and still no decompensation | Current labs against the pretreatment values | Cigna policy |
| Not covered | Use with Iqirvo (elafibranor) or Lynavoy (linerixibat), and use in alcoholic liver disease or MASLD and MASH | Medication list on the request | Cigna policy |
Livdelzi dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 10mg orally once daily, with or without food, in combination with UDCA, or as monotherapy in patients unable to tolerate UDCA. A bottle holds 30 capsules, a 30-day supply. | FDA label |
| Bile acid sequestrants | Give Livdelzi at least 4 hours before or 4 hours after the sequestrant, or at as great an interval as possible. | FDA label |
| Missed dose | The label gives no missed-dose instruction. Gilead's patient site tells patients to call their healthcare provider right away. | How to take Livdelzi |
| Renal and hepatic impairment | No dose change for mild, moderate or severe renal impairment; dialysis not studied. No dose change for Child-Pugh A; consider discontinuation on progression to Child-Pugh B or C. | FDA label |
| Age 75 and older | Limited experience; the label recommends closer monitoring for adverse events. | FDA label |
Monitoring the Livdelzi label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | Clinical and laboratory liver assessment | Required by the label before initiation | FDA label |
| During treatment | ALT, AST, total bilirubin, ALP | Per routine patient management; interrupt if they worsen or clinical hepatitis develops, consider permanent discontinuation if they worsen after restarting | FDA label |
| During treatment | Bone health | Per current standards of care; fractures in 4% against 0% in the pivotal trial, median 295 days to fracture, baseline BMD not obtained | FDA label |
| Cirrhosis | Signs of decompensation | Not recommended once decompensated; consider discontinuation at Child-Pugh B or C | FDA label |
| Any time | Right upper quadrant pain, jaundice | Interrupt while biliary obstruction is evaluated | FDA label |
| Labs | eGFR | Decline of at least 25% in 10% against 2% on placebo, none of 50% or more; stabilized or returned toward baseline, no discontinuations | FDA label |
| Outcomes | AFFIRM, the confirmatory trial in compensated cirrhosis | ClinicalTrials.gov lists it as recruiting, with an estimated completion of August 2030 | ClinicalTrials.gov |
Livdelzi drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Avoid | Probenecid, which raised seladelpar AUC 2-fold and Cmax 4.69-fold | FDA label |
| Monitor for adverse effects | Strong CYP2C9 inhibitors; dual moderate CYP2C9 and moderate or strong CYP3A4 inhibitors such as fluconazole, AUC 2.4-fold; OATP1B1, OATP1B3 and BCRP inhibitors such as cyclosporine, AUC 2.1-fold | FDA label |
| CYP2C9 poor metabolizers | Monitor more often for adverse reactions when a moderate or strong CYP3A4 inhibitor is added | FDA label |
| Rifampin | May delay or blunt the biochemical response; monitor ALP and bilirubin when it starts | FDA label |
| Bile acid sequestrants | Reduce absorption; separate by at least 4 hours | FDA label |
| No clinically significant effect | Tolbutamide, midazolam, simvastatin, atorvastatin and rosuvastatin levels were unchanged with seladelpar | FDA label |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedPlans ask for the criteria below, most often a year of ursodiol that did not work well enough or ursodiol you cannot tolerate. They also ask for no current or past liver decompensation and a gastroenterologist or hepatologist involved. The hepatologist's records usually answer it, and Gilead Support Path can explain the appeals process.
- The prescription went to a regular pharmacyGilead's prescriber site lists 3 specialty pharmacies for Livdelzi, Orsini, PANTHERx Rare and Acaria Health, plus the distributor CuraScript SD. The prescriber's office can resend the prescription to one of them. A prescription sent to the wrong pharmacy is a routing problem, not a denial.
- A copay you cannot payCommercial insurance: the Livdelzi Co-pay Savings Program, as low as $0, up to $10,000 a calendar year with no monthly limit. Medicare, Medicaid, TRICARE, VA and DoD are excluded by its terms. Our help paying page lists charity funds for people who need more help.
- No insurance at allGilead Support Path can connect eligible uninsured patients to Gilead's Patient Assistance Program. It also offers education on Medicare Part D and the Medicare Prescription Payment Plan.
- Livdelzi requested with Iqirvo or LynavoyCigna lists use with Iqirvo (elafibranor) or Lynavoy (linerixibat) as not medically necessary, citing no data on the combinations. The hepatologist decides the plan, and the insurer's rule is worth knowing first.
Gilead Support Path
- A program navigator for benefits investigation and information on prior authorization and appeals
- The Livdelzi Co-pay Savings Program for commercial insurance, as low as $0, up to $10,000 a calendar year with no monthly limit. It is not valid with Medicare including Part D, Medicaid, TRICARE, VA or DoD. Co-pay terms
- The Patient Assistance Program for eligible uninsured patients
- Education on Medicare Part D and the Medicare Prescription Payment Plan Livdelzi financial support
- A Field Reimbursement Manager the prescriber's office can request for access and reimbursement questions
Questions prescribers' offices ask about Livdelzi
What is the Livdelzi dose?
The January 2026 label gives 10mg orally once daily, with or without food. It is used in combination with UDCA in adults with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. There is one strength and no titration. Bile acid sequestrants are separated by at least 4 hours.
What monitoring does the Livdelzi label require?
The January 2026 label asks for baseline clinical and laboratory liver assessments and monitoring thereafter according to routine patient management, with no fixed interval. It adds bone health monitoring per current standards of care and monitoring of patients with cirrhosis for decompensation.
When should Livdelzi be interrupted or stopped?
The January 2026 label says to interrupt if ALT, AST, total bilirubin or ALP worsen, if clinical hepatitis develops, or if biliary obstruction is suspected. It says to consider permanent discontinuation if liver tests worsen after restarting, and discontinuation on progression to Child-Pugh B or C.
Which drugs interact with Livdelzi?
The January 2026 label says to avoid probenecid. It says to monitor for adverse effects with strong CYP2C9 inhibitors and with dual moderate CYP2C9 and moderate or strong CYP3A4 inhibitors such as fluconazole. The same applies to OATP1B1, OATP1B3 and BCRP inhibitors such as cyclosporine. With rifampin it says to monitor ALP and bilirubin.
What do insurers ask for to approve Livdelzi?
The Cigna policy shown on this page, effective August 1, 2026, asks for age 18 or older and PBC by 2 of 3 diagnostic criteria. It also requires at least 1 year of ursodiol with an inadequate response or ursodiol intolerance, no hepatic decompensation, and a gastroenterologist, hepatologist or transplant physician. It still cites the August 2024 label.
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Sources
- LIVDELZI (seladelpar) capsules prescribing information and Patient Information, revised January 2026, Gilead Sciences, via FDA Drugs@FDA and openFDA, 2026-01-30.
- NDA 217899/S-002 supplement approval letter, drug interaction and pharmacokinetic labeling, FDA, 2026-01-30.
- NDA 217899 accelerated approval letter, FDA, 2024-08-14.
- AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (NCT06051617), ClinicalTrials.gov, 2026-11-02.
- Co-pay and Gilead Support Path, LIVDELZI (seladelpar), Gilead Sciences, 2026-11-09.
- Financial Support, LIVDELZI (seladelpar), Gilead Sciences, 2026-11-09.
- Ordering, LIVDELZI (seladelpar), Gilead Sciences, 2026-11-09.
- Gilead Support Path Co-pay Enrollment, Co-pay Savings Program benefits and terms and conditions, Gilead Sciences, 2026-11-09.
- How to Take LIVDELZI, LIVDELZI (seladelpar), Gilead Sciences, 2026-11-09.
- Drug Coverage Policy IP0711, Hepatology, Livdelzi, Cigna, 2026-08-01.
A reference drawn from the January 30, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 9, 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.