Your first 90 days
Your first 90 days on Esbriet for idiopathic pulmonary fibrosis (IPF)
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.
Esbriet has no safety program forms and no vaccine standing between the prescription and the first fill. What it does have is a liver blood test before day 1 and a 2-week climb to the full dose. After that come daily habits around meals, sunlight and smoking. Stomach side effects in the trials were most common in the first 3 months, which is the stretch this page covers. It lays out those weeks from the FDA label, Legacy Pharma's own Esbriet pages and one insurer's written rules.
What has to happen before the first bottle ships
Esbriet has no REMS, so the first fill waits on a liver blood test, an insurance approval and often a question about brand or generic. These are the 5 things in the way, in order.
A liver blood test
The label asks for ALT, AST and bilirubin before the first dose, because pirfenidone can raise liver enzymes.
- Serious liver injury, including deaths, has been reported since approval.
- The result gives the pulmonologist a starting point for the monthly tests that follow.FDA label
A medicine list, with fluvoxamine and ciprofloxacin in mind
Pirfenidone is cleared mostly by a liver enzyme called CYP1A2.
- The label says fluvoxamine, which blocks that enzyme strongly, is not recommended with Esbriet and gives a lower dose if it cannot be avoided.
- Ciprofloxacin at 750mg twice a day also calls for a lower Esbriet dose.
- The pulmonologist and pharmacist weigh each of these medicines before day 1.FDA label
Smoking
In a label study, smokers had 46% of the pirfenidone exposure that nonsmokers had.
- The label asks people to stop smoking before treatment and to avoid smoking while taking Esbriet, since lower levels may change how well it works.FDA label
The insurance approval, brand or generic
Plans such as Cigna require prior authorization before they pay for pirfenidone.
- Cigna asks for a CT scan or lung biopsy showing usual interstitial pneumonia, a lung function result and a pulmonologist.
- It approves brand Esbriet only after generic pirfenidone was tried and the prescriber documents a serious problem with an inactive ingredient.Cigna policy
Help paying, from Legacy Pharma
Legacy Pharma, the company that now sells Esbriet, runs the Esbriet Co-pay Program for commercial insurance.
- Its Legacy Patient Program gives free Esbriet to eligible people without coverage or with high costs.
- Legacy Patient Program specialists answer eligibility questions at 1-866-435-8080.Esbriet assistance options
The days that matter
Counted from the first dose, with the 2-week build-up, the monthly liver tests and the refill when the first bottle runs out. 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.Liver blood test
ALT, AST and bilirubin, drawn before the first dose so the pulmonologist has a starting point.
- The label does not set an exact number of days ahead.
Insurance approval, brand or generic
The plan reviews the prior authorization and the lung function and scan reports.
- Under Cigna's policy, brand Esbriet needs generic pirfenidone tried first.
First dose, 1 tablet 3 times a day
One 267mg tablet with breakfast, lunch and dinner, which is 801mg a day for days 1 through 7.
- The label says taking it with food helps with nausea and dizziness.
Week 2, 2 tablets 3 times a day
Two 267mg tablets with each meal, which is 1,602mg a day for days 8 through 14.
- If side effects are hard to manage, the label lets the prescriber lower or pause the dose for a while.
Full dose, 801mg 3 times a day
Three 267mg tablets with each meal, or 2,403mg a day, which the label calls the full maintenance dose.
- The label says doses above that are not recommended for any patient.
Liver test, then monthly
The label calls for ALT, AST and bilirubin monthly for the first 6 months, then every 3 months.
- It also asks for a prompt test whenever symptoms of liver trouble appear.
First refill, then about every 30 days
If the first fill is one 270-tablet bottle of 267mg, it covers the 63 tablets of the build-up plus 23 days at full dose.
- After that, a 270-tablet bottle of 267mg or a 90-tablet bottle of 801mg each lasts 30 days.
Liver test, number 2
First refill, number 2
Liver test, number 3
Three months in
In the trials, stomach side effects were most frequent in the first 3 months and then became less common.
- Most sun reactions happened in the first 6 months, so sun protection still matters here.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Esbriet 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 June 9, 2025, read from the FDA's label database today. FDA label
- June 2025
Legacy Pharma published its own Esbriet label after taking over the brand. It lists only the 267mg and 801mg tablets, in bottles of 270 and 90, and gives Legacy Pharma's side effect line, 1-800-727-7151. The dosing, warnings and interaction sections match the February 2023 text.FDA label
- February 2023
Severe skin reactions were added to the warnings after an FDA safety notice. The label names Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS among them. The label says to pause Esbriet if one is suspected and stop for good if one is confirmed.FDA letter
- February 2022
This was a change to the side effects table only. The term anorexia was dropped and its cases were counted under decreased appetite.FDA letter
- July 2019
The FDA required new labeling on the risk of drug-induced liver injury, following a safety notice it sent to Genentech. The approval letter does not spell out which sentences changed.FDA letter
- January 2017
Film-coated tablets were approved in 267mg, 534mg and 801mg strengths, as an alternative to the original 267mg capsules.FDA letter
- October 2014
Esbriet capsules were first approved for idiopathic pulmonary fibrosis, under the original maker, InterMune.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.
- Three times a day, with meals
The label says to take each dose with food at the same times each day.
- Food lowers the peak level in the blood, and the label reports fewer side effects when doses were taken with food.FDA label
- If you miss a dose
Legacy Pharma's patient site says to take a missed dose with food as soon as you remember.
- It also says never to take 2 doses at the same time, and never more than 3 doses in a day.How to take Esbriet
- After a break of 14 days or more
The label says anyone who misses 14 days or more restarts with the 2-week build-up.
- After a shorter break, the earlier dose can be resumed.
- The Patient Information says to call the doctor right away after a 14-day gap.FDA label
- The brown 801mg tablet
Legacy Pharma's prescriber site describes moving people to one 801mg tablet 3 times a day once three 267mg tablets with each meal are well tolerated.
- The site says the tablets are bioequivalent, and one 801mg tablet equals three 267mg tablets.Esbriet HCP dosing
- Sun, sunlamps and tanning beds
Sun reactions occurred in 9% of people on Esbriet against 1% on placebo.
- The label asks for little sun exposure, sunscreen of SPF 50 or higher and protective clothing.
- It also asks people to avoid other medicines that make skin sensitive to light.FDA label
- Medicines that change the dose
The label names fluvoxamine and enoxacin as strong blockers of CYP1A2.
- The label lowers the Esbriet dose to 267mg 3 times a day if one cannot be avoided.
- Ciprofloxacin at 750mg twice a day lowers it to 534mg 3 times a day.
- The label also says strong CYP1A2 inducers are to be avoided during treatment.
- The pharmacist needs to hear about every new medicine, even a short course.FDA label
- Liver and kidney conditions
The label does not recommend Esbriet in severe liver impairment or in kidney failure needing dialysis.
- It asks for caution with mild or moderate liver impairment and with any kidney impairment short of dialysis.FDA label
- Pregnancy and breastfeeding
The label says the data in pregnancy are not enough to know the risk of birth defects or miscarriage.
- It is not known whether pirfenidone passes into breast milk, and the label leaves that decision to the patient and doctor.FDA label
- Brand or generic
The FDA has approved generic pirfenidone tablets and capsules from many companies, the first in January 2022.
- Whether a pharmacy fills brand or generic depends on the prescription and the plan, and the pulmonologist can explain the difference.Drugs@FDA generics
- Questions about the drug itself
Genentech's notice says that from November 3, 2025, clinical questions about Esbriet go to Legacy Pharma at 1-866-930-0188.
- Side effects can be reported to Legacy Pharma at 1-800-727-7151 or to the FDA at 1-800-FDA-1088.Genentech notice
- Storage
Room temperature, 77 degrees Fahrenheit, with short swings between 59 and 86 degrees allowed.
- Keep the bottle tightly closed, and do not use it if the seal over the opening is broken.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 the label ties to liver injury
Yellow skin or eyes, dark or tea-colored urine, pain on the upper right side of the belly, easier bleeding or bruising, or feeling tired.
- The Patient Information says to call the doctor right away.
- In the trials, liver enzymes reached 3 times the upper normal limit or more in 3.7% on Esbriet against 0.8% on placebo.FDA label
Severe skin reactions
Skin blisters, a rash, sores in the mouth, hives or any other severe skin symptom.
- The Patient Information says to call the doctor right away.
- Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS have been reported since approval.FDA label
Stomach problems
Nausea affected 36% of people on Esbriet against 16% on placebo, and indigestion 19% against 7%.
- The Patient Information says to tell the doctor right away if stomach problems get worse or do not go away.
- In the trials, 18.5% of people on Esbriet had a dose lowered or paused for stomach effects.FDA label
Sunburn or a rash
Rash affected 30% of people on Esbriet against 10% on placebo.
- The Patient Information says to talk to the doctor about any sunburn or rash.
- The label says a lower dose or a pause may be needed.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.
- 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.Cigna policy
- 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.Cigna policy
- 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.Cigna policy
- 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.Esbriet assistance options
- 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 HCP FAQs
Cigna prior authorization policy, September 15, 2026
- Age 18 or older, with idiopathic pulmonary fibrosis
- Forced vital capacity of at least 40% of predicted at baseline, before any antifibrotic, with documentation
- Diagnosis confirmed by a high-resolution CT scan or a surgical lung biopsy showing usual interstitial pneumonia, with documentation
- Prescribed by or in consultation with a pulmonologist
- For brand Esbriet tablets or capsules, generic pirfenidone tried first, and the prescriber documents that an inactive ingredient difference would cause a significant allergy or serious adverse reaction
- Not used together with nintedanib (Ofev or generic), although Jascayd (nerandomilast) alongside is allowed
Approval length. 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. 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.
- 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
Details as the drugmaker publishes them. Esbriet assistance options
Five questions for the pharmacist or the support line
- Is this prescription for brand Esbriet or generic pirfenidone, and which one does my plan cover?
- I take these medicines. Do any of them block or speed up CYP1A2, the way fluvoxamine or ciprofloxacin does?
- Do any of my other medicines also make skin more sensitive to the sun?
- How many tablets are in my first bottle, and when should I expect the refill?
- If my doctor moves me to the brown 801mg tablet, does that need a new prescription and a new approval?
Questions people ask in the first weeks
How does the Esbriet dose build up?
The label starts with one 267mg tablet 3 times a day for days 1 through 7. Days 8 through 14 use 2 tablets 3 times a day. From day 15 the dose is 3 tablets 3 times a day, or 2,403mg a day, always with food.
Do I need blood tests on Esbriet?
Yes, the label asks for liver blood tests of ALT, AST and bilirubin before the first dose. It repeats them monthly for the first 6 months, every 3 months after that, and whenever liver symptoms appear.
Is there a generic version of Esbriet?
Yes, the FDA has approved generic pirfenidone tablets and capsules since January 2022. DailyMed lists generic pirfenidone labels from many different makers. Cigna's policy covers brand Esbriet only after generic was tried and the prescriber documents a problem with an inactive ingredient. Which version fits is a question for the pulmonologist and the plan.
What if I miss a dose of Esbriet?
Legacy Pharma's patient site says to take it with food as soon as you remember. Two doses are never taken at the same time, and no more than 3 doses are taken in a day. After 14 days or more without Esbriet, the label restarts the 2-week build-up.
Can I go out in the sun on Esbriet?
The label asks people to avoid or limit sunlight, including sunlamps, and the Patient Information adds tanning beds. It calls for sunscreen of SPF 50 or higher and clothing that covers the skin. Sun reactions affected 9% of people on Esbriet against 1% on placebo, mostly in the first 6 months.
Does smoking affect Esbriet?
Yes, in a label study smokers had 46% of the pirfenidone exposure that nonsmokers had. The label says that may change how well it works. The label asks people to stop smoking before treatment and avoid it while taking Esbriet.
Who makes Esbriet now?
Legacy Pharma signed an agreement with Genentech on February 6, 2025 to acquire the US rights to Esbriet. Genentech says that from November 3, 2025, clinical questions go to Legacy Pharma at 1-866-930-0188 and side effect reports to 1-800-727-7151.
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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, June 9, 2025.
- ESBRIET- pirfenidone capsule; ESBRIET- pirfenidone tablet, coated: prescribing information, revised 2/2023, Genentech, Inc., via DailyMed, December 5, 2025.
- Financial Assistance Options for IPF Patients, Esbriet (pirfenidone), Legacy Pharma Inc. SEZC, November 9, 2026.
- Dosing & Instructions for IPF Patients, Esbriet (pirfenidone), Legacy Pharma Inc. SEZC, November 9, 2026.
- Financial Assistance Options for IPF Patients, Esbriet (pirfenidone), healthcare professional site, Legacy Pharma Inc. SEZC, November 9, 2026.
- Financial Support FAQs, Esbriet (pirfenidone), Legacy Pharma Inc. SEZC, November 9, 2026.
- Forms and Documents, Esbriet (pirfenidone), Legacy Pharma Inc. SEZC, November 9, 2026.
- Esbriet (pirfenidone) Dosing for Idiopathic Pulmonary Fibrosis (IPF), Legacy Pharma Inc. SEZC, November 9, 2026.
- Genentech: Esbriet (pirfenidone), Information for Patients, Genentech, November 9, 2026.
- Drug Coverage Policy IP0311, Pirfenidone (Pulmonary, Antifibrotics, Pirfenidone), Cigna, September 15, 2026.
- Drugs@FDA records for generic pirfenidone applications (ANDA), via openFDA, FDA, November 9, 2026.
- DailyMed - Search Results for pirfenidone, U.S. National Library of Medicine, DailyMed, November 9, 2026.
- NDA 208780/S-007 and NDA 022535/S-016 supplement approval letter, severe cutaneous adverse reactions, FDA, February 24, 2023.
- NDA 022535/S-015 and NDA 208780/S-005 supplement approval letter, decreased appetite wording, FDA, February 11, 2022.
- NDA 22535/S-012 and NDA 208780/S-002 supplement approval letter, drug-induced liver injury, FDA, July 31, 2019.
- NDA 208780 approval letter, Esbriet film-coated tablets, FDA, January 11, 2017.
- NDA 022535 approval letter, Esbriet capsules, FDA, October 15, 2014.
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 pulmonologist. Found an error? Use the report link in the footer and it will be checked against the source.