Your first 90 days
Your first 90 days on Livdelzi for 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.
Livdelzi has no REMS form, no vaccine and no boxed warning standing between the prescription and the first fill. What the label does ask for is a look at the liver before day 1 and a careful medicine list. A few drugs change how much Livdelzi reaches the blood, which is why the list matters. After that the routine is one capsule a day, a bottle a month and a short list of liver signs to report. This page lays out the first 3 months from the FDA label, Gilead's Support Path program and one insurer's written rules.
The Livdelzi label has been updated. The FDA lists a newer label dated February 3, 2026, and this page was written from the January 30, 2026 label. Trial Friend is checking what changed. Your doctor and pharmacist go by the current label.
What has to happen before the first bottle ships
Livdelzi has no REMS, so the first fill waits on baseline liver tests, an insurance approval and a specialty pharmacy's call. These are the 5 things in the way, in order.
Liver tests and a liver check before day 1
The label asks the prescriber to get baseline clinical and laboratory liver assessments before starting Livdelzi.
- It names ALT, AST, total bilirubin and alkaline phosphatase as the tests to follow.
- The label says to pause Livdelzi if they worsen during treatment.FDA label
A check for advanced liver disease
The label does not recommend Livdelzi for anyone who has or develops decompensated cirrhosis.
- That means problems such as fluid in the belly, bleeding from swollen veins or confusion.
- People with cirrhosis are watched for these signs during treatment.
- The Patient Information asks you to tell your healthcare provider if you have advanced liver disease.FDA label
A full medicine list
Probenecid is on the label's avoid list, and fluconazole and cyclosporine raise Livdelzi levels in the blood.
- Rifampin can lower them, and bile acid binding resins can reduce how much is absorbed.
- The Patient Information asks you to list every prescription, over-the-counter medicine, vitamin and herbal supplement before you start.FDA label
The insurance approval
Cigna's written policy requires prior authorization before it covers Livdelzi.
- Its policy wants at least a year of ursodiol that did not work well enough, or ursodiol you cannot tolerate.
- It also asks for no current or past liver decompensation, and a gastroenterologist, hepatologist or liver transplant physician involved.Cigna policy
The specialty pharmacy's call
Gilead says Livdelzi is supplied through a specialty pharmacy network.
- The pharmacy checks your coverage, works out your out-of-pocket cost and calls you to arrange delivery.
- Gilead warns that the call may come from a number you do not recognize, and the pharmacy calls again for each refill.Livdelzi financial support
The days that matter
Counted from the first dose, with the liver tests before it, a refill every 30 days and the insurer's 6-month renewal after. 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 liver tests and a medicine review
Blood tests of liver function and a clinical liver assessment, which the label asks for before the first dose.
- Bring a full medicine list, since the label names several drugs that change Livdelzi levels.
Insurance check, then the pharmacy calls
The specialty pharmacy checks your insurance and works out your cost, and can refer you to savings programs.
- It then calls to take your details and set up delivery.
First dose, 10mg once a day
One capsule by mouth, with or without food, alongside ursodiol or on its own as the prescriber directs.
- A bottle holds 30 capsules, which is a 30-day supply at this dose.
One month in
In the main trial, ALP was already lower on Livdelzi than on placebo at month 1.
- Whether the hepatologist checks it this early is their call, since the label sets no fixed test date.
Refill, then about every 30 days
A 30-capsule bottle runs out here at 1 capsule a day.
- The label says to keep the capsules in their original bottle, which protects them from light.
Refill, number 2
Three months in
The label asks for liver tests during treatment as part of routine care, without a fixed schedule.
- In the trial, ALP stayed lower on Livdelzi than on placebo from month 1 through month 12.
Refill, number 3
Prior authorization renewal ahead
Under Cigna's policy, the first approval of Livdelzi lasts 6 months.
- Renewal needs the prescriber to report a response, such as better ALP or bilirubin, and no liver decompensation, so recent results help.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Livdelzi 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 February 3, 2026, read from the FDA's label database today. FDA label
- January 2026
The interaction section gained new guidance from 3 lab studies, a modeling study and a population study. Exposure data for PBC patients with severe liver impairment were updated from a dedicated study. The letter lists no change to the dose, the approved use or the warnings.FDA letter
- August 2024
Accelerated approval for PBC with ursodiol, or alone when ursodiol cannot be tolerated, based on the drop in ALP. The approval required the AFFIRM outcomes trial, a pregnancy study and a breast milk study.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.
- Once a day, with or without food
The label gives 10mg by mouth once daily, with or without food.
- A study in healthy volunteers found no clinically significant change in its levels after a high-fat meal.FDA label
- If you miss a dose
The FDA label for Livdelzi does not give any rule for a missed dose.
- Gilead's patient site says to call your healthcare provider right away if you miss a dose.How to take Livdelzi
- Bile acid binding resins
The Patient Information says to take Livdelzi at least 4 hours before or after a bile acid binding resin.
- That is a kind of medicine used to help lower cholesterol.
- If that is not possible, the doses go as far apart as you can manage.FDA label
- Medicines that raise or lower Livdelzi levels
The label says to avoid taking probenecid together with Livdelzi.
- It asks prescribers to watch for side effects with fluconazole, cyclosporine and strong CYP2C9 inhibitors.
- Rifampin can delay the response, so the label asks for ALP and bilirubin checks when it starts.FDA label
- Advanced liver disease
The label does not recommend Livdelzi in decompensated cirrhosis and asks prescribers to watch people with cirrhosis for it.
- It tells prescribers to consider stopping Livdelzi if liver function falls to Child-Pugh B or C.FDA label
- Pregnancy and breastfeeding
The label says there are not enough data to know the risk in pregnancy or whether Livdelzi passes into breast milk.
- A pregnancy safety study collects outcomes, and pregnancies can be reported to Gilead at 1-800-445-3235.FDA label
- Too much Livdelzi
At 5 and 20 times the approved dose, people in trials had raised liver enzymes, muscle pain or raised muscle enzymes.
- The Patient Information says to call your healthcare provider or get emergency help right away after taking too much.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit, in the original bottle to protect it from light.
- The bottle has a child-resistant cap, and the label says to keep it out of reach of children.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.
Signs of worsening liver problems
Swelling of the belly from fluid, yellowing of the skin or eyes, or pain on the right side of the belly.
- Black, tarry or bloody stools, vomiting blood or coffee-ground vomit, and confusion or unusual sleepiness are on the list too.
- The Patient Information says to tell your healthcare provider right away.FDA label
Signs of a blocked bile duct
The label names pain under the right ribs and yellowing of the skin or eyes.
- It asks patients to report these at once, so the prescriber can pause Livdelzi while checking for a blockage.FDA label
Fractures and bone pain
In the trial, fractures occurred in 4% of people on Livdelzi and in no one on placebo, at a median of 295 days.
- The Patient Information says to report any fracture, new pain or change in how well you move around.FDA label
Headache, stomach pain, nausea, bloating and dizziness
Headache occurred in 8% on Livdelzi against 3% on placebo, and stomach pain in 7% against 2%.
- Nausea was 6% against 5%, bloating 6% against 3% and dizziness 5% against 2%.
- The stomach side effects were mild to moderate and nobody stopped for them.FDA label
A kidney blood test
In the trial, 10% of people on Livdelzi had their eGFR fall by at least 25%, against 2% on placebo.
- The drops leveled off or improved with continued treatment, and nobody stopped Livdelzi for them.
- This shows up on a blood test, not as a symptom.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, 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.Cigna policy
- 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.Livdelzi ordering
- 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.Co-pay terms
- 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 financial support
- 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.Cigna policy
Cigna prior authorization policy, August 1, 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
- At least 1 year of ursodiol with an inadequate response, or ursodiol that cannot be tolerated, according to the prescriber
- 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 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. 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.
- 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
Details as the drugmaker publishes them. Gilead Support Path
Five questions for the pharmacist or the support line
- Which specialty pharmacy are you, and what number will your delivery and refill calls come from?
- I take these medicines and supplements. Are any of them bile acid binding resins, probenecid or on the Livdelzi interaction list?
- What is my cost per bottle after insurance, and have you applied the Gilead co-pay program?
- When will you call about my next refill, and how many days ahead should I expect it?
- If my plan has a co-pay maximizer or accumulator program, how does that change what I pay?
Questions people ask in the first weeks
How long does it take to get Livdelzi after it is prescribed?
No fixed number of days applies to everyone who starts Livdelzi. The baseline liver tests, the prior authorization and the specialty pharmacy's insurance check each take their own time. Gilead Support Path offers a benefits investigation and information on prior authorization and appeals.
Can I pick up Livdelzi at my regular pharmacy?
Gilead says Livdelzi is supplied through a specialty pharmacy network. The prescriber sends the prescription to a specialty pharmacy, which checks your insurance and calls you to arrange delivery.
Is Livdelzi taken with ursodiol?
The label approves Livdelzi with ursodiol for adults who did not respond well enough to it, or alone for people who cannot tolerate it. In the main trial, 94% of people took Livdelzi together with ursodiol. Which of the 2 approved uses applies to you is the hepatologist's decision.
What if I miss a dose of Livdelzi?
The FDA label for Livdelzi does not give any rule for a missed dose. Gilead's patient site says to call your healthcare provider right away, because a missed dose lowers the amount of medicine in your body.
Does Livdelzi need blood tests?
Yes, by the label, liver tests before the first dose and during treatment as part of routine care, with no fixed schedule. The tests named are ALT, AST, total bilirubin and ALP. The hepatologist also watches bone health and, for people with cirrhosis, signs of decompensation.
Why was Livdelzi denied by my insurance?
Most often the plan wants a year of ursodiol with an inadequate response, or a record that ursodiol could not be tolerated. Plans also ask for no current or past liver decompensation and a gastroenterologist or hepatologist involved. The hepatologist's records of ursodiol and liver tests usually resolve it.
Is Livdelzi fully approved?
No, Livdelzi has accelerated approval, granted on August 14, 2024, based on a drop in ALP. The FDA's approval letter requires the AFFIRM trial in people with compensated cirrhosis, scheduled to finish in August 2029. ClinicalTrials.gov now lists an estimated completion date of August 2030 for AFFIRM.
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Sources
- LIVDELZI (seladelpar) capsules prescribing information and Patient Information, revised January 2026, Gilead Sciences, via FDA Drugs@FDA and openFDA, January 30, 2026.
- NDA 217899/S-002 supplement approval letter, drug interaction and pharmacokinetic labeling, FDA, January 30, 2026.
- NDA 217899 accelerated approval letter, FDA, August 14, 2024.
- 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, November 2, 2026.
- Co-pay and Gilead Support Path, LIVDELZI (seladelpar), Gilead Sciences, November 9, 2026.
- Financial Support, LIVDELZI (seladelpar), Gilead Sciences, November 9, 2026.
- Ordering, LIVDELZI (seladelpar), Gilead Sciences, November 9, 2026.
- Gilead Support Path Co-pay Enrollment, Co-pay Savings Program benefits and terms and conditions, Gilead Sciences, November 9, 2026.
- How to Take LIVDELZI, LIVDELZI (seladelpar), Gilead Sciences, November 9, 2026.
- Drug Coverage Policy IP0711, Hepatology, Livdelzi, Cigna, August 1, 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.