Prescribing guide
Esbriet (pirfenidone)Liver monitoring, titration, CYP1A2 interactions and prior authorization criteria for idiopathic pulmonary fibrosisFor prescribers and their offices treating idiopathic pulmonary fibrosis (IPF): 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 and bilirubin before the first dose, a CYP1A2 medication review, smoking counseling, and prior authorization, which for brand Esbriet often means generic pirfenidone first.
Example PA threshold
Cigna example: age 18 or older, FVC at least 40% predicted at baseline, UIP on HRCT or surgical biopsy, pulmonologist, generic tried first for brand, not with nintedanib.
Monitoring
ALT, AST and bilirubin at baseline, monthly for 6 months, then every 3 months and as clinically indicated; prompt testing for liver symptoms; skin and GI effects most frequent early.
Support line
Legacy Pharma, Legacy Patient Program specialists 1-866-435-8080 (enrollment fax 1-855-973-2775), Esbriet Co-pay Program to as little as $5 per 30-day supply up to $25,000 a year for commercial plans, free drug for eligible uninsured, uncovered or high out-of-pocket patients.
Give your patient their plan
A one-page handout for starting Esbriet, 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/esbrietBefore 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 |
|---|---|---|
| No REMS | The label and the FDA approval letters set no REMS and no restricted dispensing program. The label has no boxed warning and no contraindications. | FDA label |
| Baseline liver panel | ALT, AST and bilirubin before initiating treatment (section 2.1). Postmarketing drug-induced liver injury, including severe cases with fatal outcome, is in section 5.1. | FDA label |
| Medication reconciliation | Fluvoxamine and other strong CYP1A2 inhibitors such as enoxacin are not recommended and should be discontinued before the first dose. Ciprofloxacin, strong CYP1A2 inducers, agents that inhibit CYP1A2 plus CYP2C9, 2C19, 2D6 or 2E1, and photosensitizing drugs each carry a label instruction. | FDA label |
| Smoking | Instruct patients to stop smoking before treatment and to avoid smoking while on Esbriet; smokers had 46% of nonsmokers' AUC (section 8.8 and 12.3). | FDA label |
| Brand or generic | Generic pirfenidone 267mg, 534mg and 801mg tablets and 267mg capsules are approved under many ANDAs, the first on January 3, 2022, per Drugs@FDA records. | Drugs@FDA generics |
| Legacy Patient Program enrollment | The office prints the enrollment form for the patient to complete, then faxes the finished form to 1-855-973-2775. Requests are processed within 5 business days of receipt, and the office is contacted with the outcome. | Esbriet HCP assistance |
| Form signatures | The enrollment form carries patient, insurance and prescription information. The prescriber signs it, and the patient dates and signs it to permit the program to discuss health information with the office and the health plan. | Enrollment form page |
Prior authorization criteria and what to document
One public policy as the example: Cigna, September 15, 2026. Approval approved a year at a time, and renewal needs a pulmonologist and a beneficial response over the past year. Examples are a smaller than expected fall in lung function or walk distance, or fewer or milder flares. This version took effect September 15, 2026, after a review on August 6, 2026. It still cites the February 2023 label and names Genentech as the maker. That predates the June 2025 Legacy Pharma label, which kept the same dosing and warnings. Other plans set their own criteria and approval lengths. 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 |
| Lung function | FVC at least 40% of predicted at baseline, meaning before any antifibrotic (pirfenidone, nintedanib or Jascayd) | Pulmonary function report with date, marked documentation required | Cigna policy |
| Diagnosis | IPF with usual interstitial pneumonia on high-resolution CT or on surgical lung biopsy | HRCT or pathology report, marked documentation required | Cigna policy |
| Prescriber | Prescribed by or in consultation with a pulmonologist | Specialty on the request, or the consult note | Cigna policy |
| Brand exception | For Esbriet capsules or tablets, a generic pirfenidone trial plus an inactive ingredient difference that, per the prescriber, would cause a significant allergy or serious adverse reaction; the 534mg branded generic tablet has the same rule | Generic fill history and a note naming the ingredient and the reaction | Cigna policy |
| Combination | Not covered with nintedanib (Ofev or generic); concomitant Jascayd is allowed at initiation | Medication list on the request | Cigna policy |
| Renewal | Beneficial response over the last year, such as a reduction in the anticipated FVC decline, six-minute walk distance, or fewer or less severe exacerbations; approval for 1 year | Serial FVC or walk results against the pretreatment baseline | Cigna policy |
Esbriet dosing and titration
| When | Label | Source |
|---|---|---|
| Days 1 to 7 | 267mg three times daily (801mg a day), with food at the same times each day. | FDA label |
| Days 8 to 14 | 534mg three times daily (1602mg a day), as two 267mg tablets with each meal. | FDA label |
| Day 15 onward | 801mg three times daily (2403mg a day). Doses above 2403mg a day are not recommended; no more than 3 doses a day and no doubling for a missed dose. | FDA label |
| 801mg tablet | Legacy Pharma's prescriber site describes switching to one 801mg tablet three times daily once three 267mg tablets three times daily are well tolerated. The tablets are bioequivalent. | Esbriet HCP dosing |
| Supply | Legacy's label lists a 270-tablet bottle of 267mg and a 90-tablet bottle of 801mg, each 30 days at full dose. A first 270-tablet bottle covers titration plus 23 days, so the first refill falls around day 38. | FDA label |
| Older packaging | Genentech's February 2023 label, still on DailyMed, also lists 267mg capsules, a 14-day titration blister pack of 63 capsules and a 4-week maintenance blister pack. Legacy's June 2025 label lists tablets only. | Earlier FDA label |
| Interruptions | After 14 or more missed days, repeat the 2-week titration; after fewer than 14 days, resume the prior dose. | FDA label |
| Adverse reactions | For GI effects, photosensitivity or rash, consider temporary dose reduction or interruption. Interrupt for signs of SCAR and permanently discontinue if SCAR is confirmed. | FDA label |
Monitoring the Esbriet label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | ALT, AST and bilirubin | Required before initiation | FDA label |
| Monthly, months 1 to 6 | ALT, AST and bilirubin | Then every 3 months and as clinically indicated; test promptly for fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice | FDA label |
| ALT or AST above 3 to 5 times ULN, no symptoms or hyperbilirubinemia | Discontinue confounding medications, exclude other causes, monitor closely | Full dose may be maintained, or reduced or interrupted with later re-titration | FDA label |
| ALT or AST above 3 to 5 times ULN with symptoms or hyperbilirubinemia, or above 5 times ULN | Liver injury criteria | Permanently discontinue; do not rechallenge | FDA label |
| First 6 months | Photosensitivity and rash | Photosensitivity 9% against 1% on placebo, mostly in the first 6 months; sunblock SPF 50 or higher and protective clothing | FDA label |
| First 3 months | Nausea, diarrhea, dyspepsia, vomiting, GERD, abdominal pain | Dose reduction or interruption for GI events in 18.5% against 5.8%, and GI discontinuation in 2.2% against 1.0% | FDA label |
| Any time | Signs of SJS, TEN or DRESS | Interrupt until the cause is known, dermatology consultation recommended, permanently discontinue if confirmed | FDA label |
Esbriet drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Strong CYP1A2 inhibitors (fluvoxamine, enoxacin) | Not recommended; discontinue before starting and avoid. If the only drug of choice, 267mg three times daily. Fluvoxamine raised pirfenidone exposure about 4-fold in nonsmokers and 7-fold in smokers. | FDA label |
| Ciprofloxacin | At 750mg twice daily, 534mg three times daily if it cannot be avoided; exposure rose 81%. Monitor closely at 250mg or 500mg once daily. | FDA label |
| CYP1A2 plus other CYP inhibitors | Moderate or strong inhibitors of CYP1A2 and of CYP2C9, 2C19, 2D6 or 2E1 should be discontinued before and avoided during treatment. | FDA label |
| Strong CYP1A2 inducers and smoking | Discontinue strong inducers before treatment and avoid them. Smokers had 46% of nonsmokers' AUC and 68% of their Cmax. | FDA label |
| Photosensitizing drugs | The label asks patients to avoid concomitant medications known to cause photosensitivity. | FDA label |
| Hepatic and renal impairment | Use with caution in Child-Pugh A or B and in mild to severe renal impairment (CLcr 80mL/min or lower); not recommended in Child-Pugh C or end-stage renal disease on dialysis. | FDA label |
| Generic labels | DailyMed lists pirfenidone capsule and tablet labels from many generic packagers, including Macleods, Amneal, Aurobindo, Cipla, Laurus, Sandoz, Apotex, Accord and Alembic. | DailyMed generics |
Why a first fill stalls, and the fix
- The plan wants generic pirfenidone firstGeneric pirfenidone is FDA-approved, and Cigna approves brand Esbriet only after a generic trial. The prescriber must also document that an inactive ingredient would cause a significant allergy or serious reaction. This is a formulary rule, not a judgment about the diagnosis. The pulmonologist's office decides whether to change the prescription or document the exception.
- Prior authorization pending or deniedCigna asks for age 18 or older and a pulmonologist. It also wants a forced vital capacity of at least 40% of predicted, and a CT scan or biopsy showing usual interstitial pneumonia. The policy marks the lung function result and the scan or biopsy report as required documents, so the office sends both.
- Esbriet was prescribed alongside OfevCigna lists pirfenidone taken with nintedanib, sold as Ofev or generic, as not medically necessary. The same policy does allow Jascayd (nerandomilast) to be taken alongside pirfenidone. Combining treatments is the pulmonologist's decision, and the office can explain it to the plan.
- A copay you cannot payWith commercial insurance, the Esbriet Co-pay Program can lower the cost to as little as $5 per 30-day supply, up to $25,000 a year. Medicare, Medicare Advantage, Medicaid, TRICARE, VA and other government plans are excluded by its terms. Legacy Pharma points people with any insurance, Medicare included, to independent foundations, and our help paying page lists charity funds.
- The plan denied Esbriet after prior authorizationLegacy Pharma's prescriber site says a patient whose plan denied Esbriet, after any required prior authorization, can apply to the Legacy Patient Program. The program gives free Esbriet to people who meet its eligibility criteria and may ask for more information to confirm eligibility.
Esbriet Co-pay Program and Legacy Patient Program (Legacy Pharma)
- Esbriet Co-pay Program for commercial insurance, as little as $5 per 30-day supply with up to $25,000 in assistance per calendar year, not valid with Medicare, Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense or VA coverage
- Legacy Patient Program, free Esbriet for eligible people who are uninsured or whose plan does not cover Esbriet, with household income under $150,000 for up to 4 people, plus $25,000 for each extra person
- The same free-drug program for insured people whose out-of-pocket maximum is more than 7.5% of household income, with limits from under $75,000 for 1 person to under $150,000 for 4
- Enrollment by a form the patient starts and the prescriber completes, or online through HarborPath, with requests processed within 5 business days of receiving the form
- A route to the Legacy Patient Program when a plan has denied Esbriet after any required prior authorization Esbriet HCP FAQs
- Referrals to independent co-pay foundations such as the PAN Foundation, Patient Advocate Foundation and HealthWell Foundation, which people with Medicare or Medicaid can also contact
Questions prescribers' offices ask about Esbriet
What liver monitoring does the Esbriet label require?
ALT, AST and bilirubin before the first dose, monthly for the first 6 months, every 3 months thereafter and as clinically indicated, per the June 2025 label (sections 2.1 and 5.1). Test promptly if the patient reports fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. Section 2.3 sets the dose changes by ALT and AST level.
What is the Esbriet titration schedule?
267mg three times daily on days 1 to 7, 534mg three times daily on days 8 to 14 and 801mg three times daily (2403mg a day) from day 15, with food, per the June 2025 label. Doses above 2403mg a day are not recommended. After 14 or more missed days, re-titrate from the start; after a shorter gap, resume the prior dose.
How do CYP1A2 inhibitors change the Esbriet dose?
With a strong CYP1A2 inhibitor such as fluvoxamine or enoxacin that cannot be avoided, the dose is 267mg three times daily (801mg a day), and with ciprofloxacin 750mg twice daily it is 534mg three times daily (1602mg a day), per the June 2025 label (section 2.4). The label says fluvoxamine should be discontinued before starting and avoided during treatment.
Does Esbriet have a REMS?
No. The June 2025 label has no REMS, no boxed warning and no contraindications, and none of the 5 FDA approval letters reviewed, from 2014 through 2023, mentions a REMS. The gate before the first fill is the baseline liver panel and the prior authorization.
What do insurers ask for to approve Esbriet?
The Cigna policy shown here, effective September 15, 2026, asks for age 18 or older, FVC of at least 40% predicted at baseline, UIP on HRCT or surgical lung biopsy, and a pulmonologist, with approval for 1 year. Brand Esbriet also needs a documented trial of generic pirfenidone and a prescriber-documented inactive ingredient problem. The policy still cites the February 2023 Genentech label.
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Sources
- ESBRIET- pirfenidone tablet, coated: prescribing information, revised 6/2025, and Patient Information, revised March 2025, Legacy Pharma USA Inc., via DailyMed, 2025-06-09.
- ESBRIET- pirfenidone capsule; ESBRIET- pirfenidone tablet, coated: prescribing information, revised 2/2023, Genentech, Inc., via DailyMed, 2025-12-05.
- Financial Assistance Options for IPF Patients, Esbriet (pirfenidone), Legacy Pharma Inc. SEZC, 2026-11-09.
- Dosing & Instructions for IPF Patients, Esbriet (pirfenidone), Legacy Pharma Inc. SEZC, 2026-11-09.
- Financial Assistance Options for IPF Patients, Esbriet (pirfenidone), healthcare professional site, Legacy Pharma Inc. SEZC, 2026-11-09.
- Financial Support FAQs, Esbriet (pirfenidone), Legacy Pharma Inc. SEZC, 2026-11-09.
- Forms and Documents, Esbriet (pirfenidone), Legacy Pharma Inc. SEZC, 2026-11-09.
- Esbriet (pirfenidone) Dosing for Idiopathic Pulmonary Fibrosis (IPF), Legacy Pharma Inc. SEZC, 2026-11-09.
- Genentech: Esbriet (pirfenidone), Information for Patients, Genentech, 2026-11-09.
- Drug Coverage Policy IP0311, Pirfenidone (Pulmonary, Antifibrotics, Pirfenidone), Cigna, 2026-09-15.
- Drugs@FDA records for generic pirfenidone applications (ANDA), via openFDA, FDA, 2026-11-09.
- DailyMed - Search Results for pirfenidone, U.S. National Library of Medicine, DailyMed, 2026-11-09.
- NDA 208780/S-007 and NDA 022535/S-016 supplement approval letter, severe cutaneous adverse reactions, FDA, 2023-02-24.
- NDA 022535/S-015 and NDA 208780/S-005 supplement approval letter, decreased appetite wording, FDA, 2022-02-11.
- NDA 22535/S-012 and NDA 208780/S-002 supplement approval letter, drug-induced liver injury, FDA, 2019-07-31.
- NDA 208780 approval letter, Esbriet film-coated tablets, FDA, 2017-01-11.
- NDA 022535 approval letter, Esbriet capsules, FDA, 2014-10-15.
A reference drawn from the June 9, 2025 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.