Prescribing guide
Iqirvo (elafibranor)Dosing, muscle and liver monitoring, contraception, 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.
Dispensing gate
No REMS; assessment for muscle pain or myopathy, pregnancy status in females of reproductive potential, baseline clinical and laboratory liver assessment, a check for decompensated cirrhosis, a medication and contraceptive review, prior authorization, and routing to Iqirvo's limited specialty pharmacy 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, periodic clinical exam and CPK to be considered, bone health per standard of care, decompensation in patients with cirrhosis; ALP and bilirubin when rifampin starts.
Support line
IPSEN CARES, (866) 435-5677, Monday to Friday 8 AM to 8 PM ET, enrollment fax (855) 465-3820; benefits verification, PA and appeals information, copay as little as $0 for eligible commercial patients with an annual maximum, Patient Assistance Program for uninsured or functionally uninsured patients, specialty pharmacy triage.
Give your patient their plan
A one-page handout for starting Iqirvo, 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/iqirvoBefore 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 |
|---|---|---|
| Muscle assessment | The label says to evaluate for muscle pain or myopathy before initiating Iqirvo. Rhabdomyolysis with acute kidney injury occurred in 1 treated patient who had cirrhosis and was on a stable statin dose. | FDA label |
| Pregnancy status and contraception | Verify that females of reproductive potential are not pregnant before initiation. Advise them to avoid hormonal contraceptives containing ethinyl estradiol and to use progestin-only contraceptives containing levonorgestrel or norgestrel, intrauterine systems, or effective non-hormonal contraceptives during treatment and for 3 weeks after the last dose. | FDA label |
| Baseline liver assessment | The label asks for baseline clinical and laboratory assessments at treatment 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 | Strong CYP2C8 inhibitors such as gemfibrozil are to be avoided. Statins, other PPAR-alpha agonists, PPAR-gamma agonists 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 |
| Enroll in IPSEN CARES | Ipsen gives 3 ways to send the enrollment form: complete and submit online, complete online and fax, or print and fax to (855) 465-3820. The patient must review and sign the patient authorization section, in the office or online. | Iqirvo access support |
| Route to a specialty pharmacy | The enrollment form lists a limited specialty pharmacy network: AcariaHealth, Accredo Health Group, AllianceRx Walgreens Pharmacy, CenterWell Specialty Pharmacy, CVS Specialty and Optum Specialty Pharmacy. Completing its prescription section lets IPSEN CARES triage the prescription; a preferred pharmacy is honored if the patient's insurance permits. | IPSEN CARES enrollment |
| IPSEN CARES services | The program verifies coverage, advises whether a PA is required and provides information on the payer appeal process. It determines eligibility for copay support and the Patient Assistance Program and, once coverage is secured, can help direct the prescription to a specialty pharmacy. Patient Access Managers are available Monday to Friday, 8 AM to 8 PM ET, at 866-435-5677. | IPSEN CARES for prescribers |
| Coverage delay or no insurance | For a commercially insured patient with a payer coverage delay, IPSEN CARES may be able to provide temporary assistance. The Patient Assistance Program may provide Iqirvo free to patients who are uninsured or functionally uninsured and meet its financial eligibility requirements; enrollment in IPSEN CARES is required to apply. | Iqirvo financial assistance |
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 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.
| 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 Livdelzi (seladelpar) or Lynavoy (linerixibat), and use in alcoholic liver disease or MASLD and MASH | Medication list on the request | Cigna policy |
Iqirvo dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 80mg orally once daily, with or without food, in combination with UDCA, or as monotherapy in patients unable to tolerate UDCA. Supplied as a child-resistant 30-count bottle, a 30-day supply. | FDA label |
| Bile acid sequestrants | Give Iqirvo 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. Ipsen's patient site tells patients not to take more than 1 tablet per day, even if they miss a dose. | Starting Iqirvo |
| Renal and hepatic impairment | Same dose in mild, moderate or severe renal impairment. No dose change for Child-Pugh A; consider discontinuation on progression to Child-Pugh B or C. | FDA label |
| Age 65 and older | No dose adjustment. Clinical experience above age 75 is limited, and the label recommends closer monitoring of adverse events in patients older than 75. | FDA label |
| Lactation | Advise patients not to breastfeed during treatment and for 3 weeks after the last dose. | FDA label |
Monitoring the Iqirvo label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Before initiation | Muscle pain or myopathy | Recommended evaluation before initiating (label section 2.1) | FDA label |
| Before initiation | Pregnancy status in females of reproductive potential | Verify the patient is not pregnant; may cause fetal harm based on animal data | FDA label |
| Baseline | Clinical and laboratory liver assessment | Obtain at treatment 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. DILI in 1 patient at 80mg and 2 at 1.5 times the dose, median onset of liver test elevation 85 days (range 57 to 288). In Study 1, ALT and AST at least 5 times ULN in 6% against 6%, and total bilirubin above 3 times ULN in 2% against 0% | FDA label |
| During treatment | Clinical exam, CPK | Consider periodic assessment, especially with new or worsening muscle pain or myopathy; interrupt for new or worsening muscle pain, myopathy or rhabdomyolysis; may restart if another cause is identified and resolved, discontinue on recurrence. CPK above 3 times ULN in 4% against 0% in Study 1 | FDA label |
| During treatment | Bone health | Per current standards of care; fractures in 6% against 0% in Study 1, median 122 days to fracture (interquartile range 48 to 258) | 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 if biliary obstruction is suspected and treat as clinically indicated; new cholelithiasis in 3% against 0% in Study 1 | FDA label |
| Any time | Hypersensitivity | Severe: discontinue permanently. Mild or moderate: interrupt, treat promptly and monitor until resolved; discontinue permanently if it recurs on rechallenge. Seen 2 to 30 days after initiation at 1.5 times the dose | FDA label |
| Outcomes | ELFIDENCE, the long-term clinical outcomes trial | ClinicalTrials.gov lists it as recruiting, with an estimated completion of May 2029 | ClinicalTrials.gov |
Iqirvo drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Hormonal contraceptives | Iqirvo is a weak CYP3A4 inducer. With a combined oral contraceptive, ethinyl estradiol Cmax fell 20% and AUC 35% while levonorgestrel was unaffected. Switch to progestin-only products containing levonorgestrel or norgestrel, intrauterine systems, or effective non-hormonal contraceptives during treatment and for at least 3 weeks after the last dose. | FDA label |
| Statins | Can increase the risk of myopathy by a mechanism not fully characterized. Monitor for muscle injury, consider periodic clinical exam and CPK, and interrupt Iqirvo for new or worsening muscle pain or myopathy. | FDA label |
| Avoid | Strong CYP2C8 inhibitors such as gemfibrozil, which may raise exposure to the active metabolite GFT1007. If concomitant use cannot be avoided, monitor for adverse reactions. | FDA label |
| Other PPAR-alpha agonists | Fenofibrate and fenofibric acid may increase the risk of liver injury and muscle injury; monitor for both | FDA label |
| PPAR-gamma agonists | Pioglitazone and rosiglitazone may increase the risk of liver injury; monitor for it | FDA label |
| Rifampin | May reduce exposure and delay or blunt the biochemical response; monitor ALP and bilirubin when it starts | FDA label |
| Bile acid sequestrants | May reduce absorption and efficacy; separate by at least 4 hours | FDA label |
| No clinically significant effect | Warfarin exposure and INR were unchanged with elafibranor, the falls in simvastatin acid and atorvastatin exposure were not considered clinically meaningful, and indomethacin did not change elafibranor or GFT1007 levels | 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 IPSEN CARES provides information on the payer appeal process.
- 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.
- 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.
- 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.
- 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 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.
IPSEN CARES
- 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
Questions prescribers' offices ask about Iqirvo
What is the Iqirvo dose?
The August 2026 label gives 80mg 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 evaluation and monitoring does the Iqirvo label require?
The August 2026 label asks for 2 evaluations before initiation: muscle pain or myopathy, and pregnancy status in females of reproductive potential. It also asks for baseline clinical and laboratory liver assessments, with monitoring thereafter according to routine patient management. It says to consider periodic clinical exam and CPK measurement, and to monitor bone health per current standards of care.
When should Iqirvo be interrupted or stopped?
The August 2026 label gives 4 reasons to interrupt: new or worsening muscle pain, myopathy or rhabdomyolysis; worsening ALT, AST, total bilirubin or ALP or clinical hepatitis; suspected biliary obstruction; and a mild or moderate hypersensitivity reaction. It says to discontinue permanently for a severe hypersensitivity reaction or one that recurs on rechallenge, and to discontinue if muscle signs recur after a restart. 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 Iqirvo?
The August 2026 label lists 7 interactions: hormonal contraceptives, statins, strong CYP2C8 inhibitors, other PPAR-alpha agonists, PPAR-gamma agonists, rifampin and bile acid sequestrants. It says to avoid strong CYP2C8 inhibitors such as gemfibrozil, and to avoid hormonal contraceptives containing ethinyl estradiol in females of reproductive potential. Statins and fenofibrate call for muscle injury monitoring; fenofibrate, pioglitazone and rosiglitazone call for liver injury monitoring. With rifampin it says to monitor ALP and bilirubin.
What do insurers ask for to approve Iqirvo?
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 June 2024 label.
Free email alert
Get an email when the Iqirvo label changes
One email the day the FDA revises the Iqirvo prescribing information, with a summary of what changed. No trial alerts or newsletter, and you can stop anytime.
Label changes for Iqirvo only, usually a few a year and some years none. Stop anytime. We never share your email. Privacy policy
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, 2026-08-11.
- NDA 218860/S-003 supplement approval and fulfillment of postmarketing requirement and commitment, FDA, 2026-08-07.
- NDA 218860 accelerated approval letter, FDA, 2024-06-10.
- 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, 2026-10-23.
- IPSEN CARES®| IQIRVO® (elafibranor) Patient Site, Ipsen Biopharmaceuticals, 2026-11-13.
- Iqirvo HCP Patient Support Services | Ipsen Cares®, Ipsen Biopharmaceuticals, 2026-11-13.
- Iqirvo Copay & Patient Assistance Details for HCPs | Ipsen Cares®, Ipsen Biopharmaceuticals, 2026-11-13.
- Enroll Your Patient in Iqirvo Support Program | Ipsen Cares®, Ipsen Biopharmaceuticals, 2026-11-13.
- IQIRVO Patient Access | Official HCP Site, Ipsen Biopharmaceuticals, 2026-11-13.
- Starting treatment | IQIRVO® (elafibranor) Patient Site, Ipsen Biopharmaceuticals, 2026-11-13.
- Drug Coverage Policy IP0710, Hepatology, Iqirvo, Cigna, 2026-08-01.
A reference drawn from the August 11, 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.