Your first 90 days
Your first 90 days on Iqirvo 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.
Iqirvo has no REMS form and no boxed warning standing between the prescription and the first fill. What the label does ask for is a muscle check, baseline liver tests and a careful medicine list. Women who could become pregnant also get a pregnancy check and a talk about birth control. After that the routine is one tablet a day, a bottle a month and a short list of signs to report. This page lays out the first 3 months from the FDA label, Ipsen's IPSEN CARES program and one insurer's written rules.
What has to happen before the first bottle ships
Iqirvo has no REMS, so the first fill waits on a muscle check, baseline liver tests, an insurance approval and a specialty pharmacy. These are the 6 things in the way, in order.
A muscle check before day 1
The label asks the prescriber to check for muscle pain or muscle disease before starting Iqirvo.
- It says to consider repeat checks during treatment, by exam or by a CPK blood test.
- CPK is an enzyme that the Medication Guide says can be a sign of muscle damage.FDA label
Liver tests and a check for advanced liver disease
The label asks for baseline clinical and laboratory liver assessments when treatment starts, then monitoring as part of routine care.
- It does not recommend Iqirvo for anyone who has or develops decompensated cirrhosis.
- That means problems such as fluid in the belly, bleeding from swollen veins or confusion.FDA label
A pregnancy check and a birth control plan
For women who could become pregnant, the label asks the prescriber to confirm there is no pregnancy before the first dose.
- It advises avoiding hormonal birth control that contains ethinyl estradiol, because Iqirvo may make it less effective.
- The alternatives it names are progestin-only methods with levonorgestrel or norgestrel, intrauterine systems, or effective non-hormonal methods.FDA label
A full medicine list
The label says to avoid strong CYP2C8 inhibitors such as gemfibrozil.
- It asks prescribers to monitor people who also take statins, fenofibrate, pioglitazone, rosiglitazone or rifampin.
- The Medication Guide asks you to list every prescription, over-the-counter medicine, vitamin and herbal supplement, and any hormonal birth control.FDA label
The insurance approval
Cigna's written policy requires prior authorization before it covers Iqirvo.
- 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 and IPSEN CARES
Ipsen's enrollment form describes a limited specialty pharmacy network for Iqirvo.
- If the prescriber enrolls you in IPSEN CARES, you sign a patient authorization and the program runs a benefits check.
- The prescriber can also ask the program to send the prescription to a pharmacy in that network.IPSEN CARES enrollment
The days that matter
Counted from the first dose, with the checks 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.Muscle check, liver tests and a medicine review
A check for muscle pain or muscle disease, plus baseline liver tests, which the label asks for before treatment starts.
- Bring a full medicine list, since the label names several drugs that interact with Iqirvo.
Pregnancy check and birth control plan, if they apply
For women who could become pregnant, the label asks the prescriber to confirm there is no pregnancy before starting.
- It advises against birth control containing ethinyl estradiol during treatment and for 3 weeks after the last dose.
Insurance check, then the specialty pharmacy
IPSEN CARES verifies insurance coverage for enrolled patients and tells the office whether a prior authorization is needed.
- Once coverage is secured, it can help direct the prescription to a specialty pharmacy.
First dose, 80mg once a day
One tablet by mouth, with or without food, alongside ursodiol or on its own as the prescriber directs.
- A bottle holds 30 tablets, which is a 30-day supply at this dose.
Four weeks in
In the main trial, ALP was already lower on Iqirvo than on placebo by week 4.
- 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-tablet bottle runs out here at 1 tablet a day.
- The label says to store the tablets in the original bottle and carton, which protects them from moisture and light.
Refill, number 2
Three months in
The label asks for liver tests during treatment as part of routine care, without a fixed schedule.
- Among the 3 people with drug-induced liver injury in trials, liver tests began rising at a median of 85 days.
- Muscle pain in the main trial began at a median of 85.5 days.
Refill, number 3
Prior authorization renewal ahead
Under Cigna's policy, the first approval of Iqirvo 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 Iqirvo 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 August 11, 2026, read from the FDA's label database today. FDA label
- August 2026
The FDA approved changes based on a study of Iqirvo with a combined birth control pill. The label now advises avoiding birth control that contains ethinyl estradiol and names the alternatives. Its list of recent changes marks the muscle, pregnancy and liver warnings as revised. Compared with the June 2024 label, the muscle warning adds a restart rule and monitoring alongside fenofibrate. The liver warning adds monitoring alongside fenofibrate, pioglitazone and rosiglitazone, and the interaction table adds strong CYP2C8 inhibitors such as gemfibrozil.FDA letter
- June 2024
Accelerated approval for PBC with ursodiol, or alone when ursodiol cannot be tolerated, based on the drop in ALP. The approval required a long-term outcomes trial, a pregnancy study, a breast milk study and drug interaction studies.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 80mg by mouth once daily, with or without food.
- A high-fat meal lowered peak blood levels in a study, and the label says the difference was not clinically meaningful.FDA label
- If you miss a dose
The FDA label for Iqirvo does not give any rule for a missed dose.
- Ipsen's patient site says not to take more than 1 tablet a day, even if you miss a dose.Starting Iqirvo
- Bile acid binding resins
The Medication Guide says to take Iqirvo at least 4 hours before or 4 hours after a bile acid binding resin.
- If that is not possible, the doses go as far apart as you can manage.FDA label
- Birth control
The label says Iqirvo may make birth control containing ethinyl estradiol less effective.
- It advises women who could become pregnant to avoid those products and use another method.
- The methods it names are progestin-only products with levonorgestrel or norgestrel, intrauterine systems, or effective non-hormonal methods.
- This advice covers treatment and the 3 weeks after the last dose.FDA label
- Pregnancy and breastfeeding
The label says Iqirvo may harm an unborn baby, based on animal studies.
- The Medication Guide says you should not become pregnant during treatment with Iqirvo.
- The Medication Guide says to tell your healthcare provider right away about a pregnancy or a possible pregnancy.
- A pregnancy registry takes reports from patients or healthcare providers at 1-844-990-0239.
- The Medication Guide says not to breastfeed during treatment and for 3 weeks after the last dose.FDA label
- Statins, fibrates and other medicines
The label says to avoid strong CYP2C8 inhibitors such as gemfibrozil.
- With statins it asks prescribers to watch for muscle injury, and with fenofibrate for muscle and liver injury.
- Pioglitazone and rosiglitazone call for liver monitoring, and rifampin calls for ALP and bilirubin checks when it starts.FDA label
- Advanced liver disease
The label does not recommend Iqirvo in decompensated cirrhosis and asks prescribers to watch people with cirrhosis for it.
- It tells prescribers to consider stopping Iqirvo if liver function falls to Child-Pugh B or C.FDA label
- Storage
Room temperature, 59 to 86 degrees Fahrenheit, in the original bottle and carton to protect it from moisture and light.
- The bottle is child-resistant, and the Medication Guide says to keep it out of the 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.
Muscle pain, soreness or weakness
The Medication Guide lists severe muscle pain, unexplained soreness, unexplained muscle weakness and dark, reddish urine.
- It says to call your healthcare provider right away about any of them.
- In the trial, 1 person on Iqirvo had severe muscle breakdown with kidney injury.
- Raised CPK was the most common reason people stopped treatment, at 4%.FDA label
Signs of worsening liver problems
Swelling of the belly from fluid, yellowing of the skin or the whites of the eyes, and black, tarry or bloody stools.
- Coughing up or vomiting blood, coffee-ground vomit, and confusion or unusual sleepiness are on the list too.
- The Medication Guide says to tell your healthcare provider right away.FDA label
Symptoms that are severe or do not go away
The Medication Guide lists stomach pain, nausea, vomiting, diarrhea, loss of appetite or weight loss, and new or worsening fatigue.
- Weakness, fever and chills, light-headedness and less frequent urination are on the same list.
- It says to tell your healthcare provider right away if they are severe or do not go away.FDA label
An allergic reaction
The Medication Guide lists rash, trouble breathing, itching, and swelling of the face, lips, tongue or throat.
- It says to stop taking Iqirvo and call your healthcare provider right away or go to the nearest emergency room.
- The reactions it describes happened 2 to 30 days after taking Iqirvo.FDA label
Signs of gallstones or a blocked bile duct
The Medication Guide says Iqirvo may raise the risk of gallstones.
- It says to call your healthcare provider right away for pain in the upper right stomach area or yellowing of the skin.
- In the trial, new gallstones were found in 3% of people on Iqirvo and in no one on placebo.FDA label
Fractures and bone pain
In the trial, fractures occurred in 6% of people on Iqirvo and in no one on placebo, at a median of 122 days.
- The Medication Guide says to report any fracture, new pain or change in how well you move around.FDA label
Weight gain and stomach side effects
Weight gain occurred in 23% on Iqirvo against 21% on placebo, and diarrhea in 11% against 9%.
- Stomach pain and nausea were each 11% against 6%, and vomiting was 11% against 2%.
- Most of the stomach and bowel events in the trial were mild or moderate.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 IPSEN CARES provides information on the payer appeal process.Cigna policy
- The prescription went to a regular pharmacyIpsen's enrollment form lists a limited specialty pharmacy network for Iqirvo. It names AcariaHealth, Accredo, AllianceRx Walgreens Pharmacy, CenterWell Specialty Pharmacy, CVS Specialty and Optum Specialty Pharmacy. The prescriber's office can ask IPSEN CARES to send the prescription to one of them.IPSEN CARES enrollment
- A copay you cannot payCommercial insurance: the Iqirvo Copay Assistance Program, as little as $0, up to an annual maximum that Ipsen's page does not state. Medicare Part B and Part D, Medicaid, Medigap, VA, DoD and TRICARE are excluded by its terms. Our help paying page lists charity funds for people who need more help.IPSEN CARES
- No insurance at allThe Iqirvo Patient Assistance Program may provide Iqirvo free to people who are uninsured or functionally uninsured and meet its financial criteria. Enrollment in IPSEN CARES is required before a person can apply.Iqirvo financial assistance
- A coverage delay with commercial insuranceIpsen says IPSEN CARES may be able to provide temporary assistance during a payer coverage delay for people with commercial insurance. The prescriber's office can call IPSEN CARES at (866) 435-5677 to ask about it.Iqirvo financial assistance
- Iqirvo requested with Livdelzi or LynavoyCigna lists use with Livdelzi (seladelpar) 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 June 2024 prescribing information. The August 2026 label revision changed the birth control advice and some warnings, 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 dedicated Patient Access Manager who explains health insurance needs and helps identify financial support programs
- The Iqirvo Copay Assistance Program for commercial insurance, as little as $0, with an annual calendar year maximum. It is not open to people enrolled in Medicare Part B or Part D, Medicaid, Medigap, VA, DoD or TRICARE.
- A Patient Education Liaison who provides education about the condition and treatment with Iqirvo
- The Iqirvo Patient Assistance Program, free medicine for eligible people who are uninsured or functionally uninsured and meet its financial criteria Iqirvo financial assistance
- Benefits verification, prior authorization and appeals information, and help directing the prescription to a specialty pharmacy IPSEN CARES for prescribers
Details as the drugmaker publishes them. IPSEN CARES
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 statins, fibrates such as gemfibrozil or fenofibrate, or bile acid binding resins?
- Does my birth control contain ethinyl estradiol?
- What is my cost per bottle after insurance, and has the Iqirvo copay program been applied?
- When will my next refill be ready, and how many days ahead should I expect to hear from you?
Questions people ask in the first weeks
How long does it take to get Iqirvo after it is prescribed?
No fixed number of days applies to everyone who starts Iqirvo. The muscle and liver checks, the prior authorization and the specialty pharmacy step each take their own time. IPSEN CARES offers benefits verification and information on prior authorization and appeals.
Can I pick up Iqirvo at my regular pharmacy?
Ipsen's enrollment form describes a limited specialty pharmacy network for Iqirvo and names 6 pharmacies in it. The prescriber can ask IPSEN CARES to send the prescription to a pharmacy in that network.
Is Iqirvo taken with ursodiol?
The label approves Iqirvo with ursodiol for adults who did not respond well enough to it, or alone for people who cannot tolerate it. In the main trial, 95% of people took Iqirvo or placebo together with ursodiol. Which of the 2 approved uses applies to you is the hepatologist's decision.
What if I miss a dose of Iqirvo?
The FDA label for Iqirvo does not give any rule for a missed dose. Ipsen's patient site says not to take more than 1 tablet a day, even if you miss a dose.
Does Iqirvo need blood tests?
Yes, by the label, liver tests when treatment starts and during treatment as part of routine care, with no fixed schedule. The tests named are ALT, AST, total bilirubin and ALP. The label also says to consider periodic muscle checks, by exam or a CPK blood test.
Can I take birth control pills with Iqirvo?
The August 2026 label advises women who could become pregnant to avoid hormonal birth control containing ethinyl estradiol. In a study with a combined pill, Iqirvo lowered ethinyl estradiol exposure by 35% and left levonorgestrel unaffected. The label names progestin-only levonorgestrel or norgestrel products, intrauterine systems and effective non-hormonal methods as alternatives.
Why was Iqirvo 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 Iqirvo fully approved?
No, Iqirvo has accelerated approval, granted on June 10, 2024, based on a drop in ALP. The label says a benefit on survival or liver decompensation has not been shown. The FDA's June 2024 approval letter required an outcomes trial and gave May 2029 as its planned completion date. A later FDA letter, from August 2026, says the confirmatory trial requirement is still open. ClinicalTrials.gov lists that trial, ELFIDENCE, as recruiting, with an estimated completion date of May 2029.
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Sources
- DailyMed - IQIRVO- elafibranor tablet, film coated (updated August 11, 2026, SPL version 4, prescribing information and Medication Guide revised 08/2026), Ipsen Biopharmaceuticals, via DailyMed and openFDA, August 11, 2026.
- NDA 218860/S-003 supplement approval and fulfillment of postmarketing requirement and commitment, FDA, August 7, 2026.
- NDA 218860 accelerated approval letter, FDA, June 10, 2024.
- ELFIDENCE: A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC) (NCT06016842), ClinicalTrials.gov, October 23, 2026.
- IPSEN CARES®| IQIRVO® (elafibranor) Patient Site, Ipsen Biopharmaceuticals, November 13, 2026.
- Iqirvo HCP Patient Support Services | Ipsen Cares®, Ipsen Biopharmaceuticals, November 13, 2026.
- Iqirvo Copay & Patient Assistance Details for HCPs | Ipsen Cares®, Ipsen Biopharmaceuticals, November 13, 2026.
- Enroll Your Patient in Iqirvo Support Program | Ipsen Cares®, Ipsen Biopharmaceuticals, November 13, 2026.
- IQIRVO Patient Access | Official HCP Site, Ipsen Biopharmaceuticals, November 13, 2026.
- Starting treatment | IQIRVO® (elafibranor) Patient Site, Ipsen Biopharmaceuticals, November 13, 2026.
- Drug Coverage Policy IP0710, Hepatology, Iqirvo, 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.