Your first 90 days
Your first 90 days on Ofev 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.
Ofev has no safety program forms standing between the prescription and the first fill. What it does have is a liver blood test before day 1, plus a pregnancy test for anyone who could become pregnant. After that come 2 capsules a day with food and a plan for diarrhea, which mostly starts in the first 3 months. The label says most liver problems also appear in those 3 months, which is the stretch this page covers. It lays out those weeks from the FDA label, Boehringer Ingelheim's own Ofev pages and one insurer's written rules.
What has to happen before the first bottle ships
Ofev has no REMS, so the first fill waits on a liver blood test, sometimes a pregnancy test, an insurance approval and a specialty pharmacy. These are the 8 things in the way, in order.
A liver blood test
The label asks for ALT, AST and bilirubin before the first dose, because nintedanib can raise liver enzymes.
- Serious liver injury, including deaths, has been reported since approval.
- The label says people under 65kg (about 143 pounds), Asian patients and women may have a higher risk of enzyme rises.FDA label
A pregnancy test and birth control
The label asks for a pregnancy test before the first dose in anyone who could become pregnant.
- The Patient Information says Ofev can cause birth defects or death to an unborn baby.
- The label calls for highly effective birth control at the start, during treatment and for at least 3 months after the last dose.FDA label
Liver conditions and medical history
The label does not recommend Ofev for people with moderate or severe liver impairment, called Child Pugh B or C. With mild impairment, Child Pugh A, the label gives 100mg twice a day.
- The Patient Information also asks about heart problems, blood clots, bleeding problems and recent surgery in the stomach area.FDA label
A medicine list, with P-gp and CYP3A4 in mind
Nintedanib is handled by a transporter called P-gp and, to a minor extent, by the enzyme CYP3A4.
- The label says to avoid drugs that speed these up, such as carbamazepine, phenytoin and St. John's wort.
- Blockers such as ketoconazole or erythromycin can raise nintedanib levels, and the label asks for close monitoring.
- Blood thinners matter too, because Ofev may raise the risk of bleeding.FDA label
Smoking
In the label's analysis, current smokers had 21% lower nintedanib exposure than former smokers and people who never smoked.
- The label asks people to stop smoking before treatment and to avoid smoking while taking Ofev, 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 nintedanib.
- Cigna asks for a CT scan or lung biopsy showing usual interstitial pneumonia, a lung function result and a pulmonologist.
- On its employer plans, brand Ofev is approved only after generic nintedanib was tried and cannot be taken.
- The reason must be an inactive ingredient difference that would cause a significant allergy or serious adverse reaction.Cigna policy
A prescription form and a specialty pharmacy
Boehringer's prescriber site has the office fax a Prescription Form to a specialty pharmacy.
- That pharmacy reviews the insurance coverage, checks whether prior authorization is required and delivers Ofev to the home.
- The site lists 6 partnering specialty pharmacies, including Accredo, CVS/Caremark and Optum.Access for Ofev
CareConnect4Me enrollment
Patients can be enrolled in CareConnect4Me online, by phone at 1-866-673-6366, or with a form sent by fax or mail.
- Boehringer describes it as a personal Ofev care team offering health, financial and social resource support.CareConnect4Me
The days that matter
Counted from the first dose, with the liver tests of the first 3 months and the refill every 30 days. 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, and a pregnancy test where it applies
ALT, AST and bilirubin are drawn before the first dose, with a pregnancy test for anyone who could become pregnant.
- The label does not set an exact number of days ahead.
Insurance approval, brand or generic
The plan reviews the prior authorization with the lung function and scan reports.
- Under Cigna's employer plan rules, brand Ofev needs generic nintedanib tried first.
Specialty pharmacy delivery
The specialty pharmacy that received the Prescription Form reviews coverage and delivers Ofev directly to the home.
- Boehringer's prescriber site lists 6 partnering specialty pharmacies for Ofev prescriptions.
First dose, 150mg twice a day
One 150mg capsule with food, then a second about 12 hours later, also with food.
- Capsules are swallowed whole with liquid, and the label gives the full dose from day 1.
Liver tests at regular intervals
The label calls for ALT, AST and bilirubin at regular intervals during the first 3 months.
- It does not name exact days, so the pulmonologist sets the schedule.
- The label also asks for a prompt test whenever symptoms of liver trouble appear.
Refill, then every 30 days
A bottle holds 60 capsules, which is 30 days at 2 capsules a day.
- The label lists the same 60-capsule bottle for both the 150mg and 100mg strengths.
Refill, number 2
Three months in
The label says most liver problems happen within the first 3 months of treatment.
- In most people who had diarrhea in the trials, it also began in that stretch.
- After month 3, the label continues liver tests periodically or as the doctor sees a need.
Refill, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Ofev 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 November 20, 2025, read from the FDA's label database today. FDA label
- May 2025
The prescribing information and the Patient Information now on DailyMed both carry a May 2025 revision date. Drugs@FDA posts no approval letter for that revision, and its newest letter is from October 2024. What changed in May 2025 is not confirmed here.Drugs@FDA
- October 2024
Posterior reversible encephalopathy syndrome, a brain condition, was added to the list of side effects reported since approval.FDA letter
- June 2024
The section on use in children was updated with a pediatric study and animal findings. The label says effectiveness was not shown in that study, which treated 26 children aged 6 to 17.FDA letter
- January 2022
Protein in the urine was added to the warnings, side effects and patient counseling sections. Instructions on handling the capsules were added to the label, the Patient Information and the carton.FDA letter
- October 2020
Birth control and drug interaction wording was updated after a required study of a combined birth control pill taken with Ofev. The label now says nintedanib did not change exposure to that pill.FDA letter
- March 2020
A third use was approved, chronic fibrosing interstitial lung diseases with a progressive phenotype.FDA letter
- September 2019
A second use was approved, slowing the decline in lung function in systemic sclerosis-associated interstitial lung disease.FDA letter
- October 2014
Ofev capsules, 100mg and 150mg, were first approved for idiopathic pulmonary fibrosis. The FDA also required a study in people with liver impairment after approval.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.
- Twice a day, with food
The label gives 150mg twice a day, about 12 hours apart, taken with food.
- In the label's study, food raised nintedanib exposure by about 20% compared with an empty stomach.FDA label
- Swallow the capsules whole
Capsules are swallowed whole with liquid and are not chewed, crushed or opened.
- The label says they should not be chewed because of a bitter taste.
- If the contents touch you or a caregiver, the Patient Information says to wash hands well right away.FDA label
- No build-up period
Boehringer's prescriber site says there is no up-titration when starting, and 150mg twice a day is the recommended dose.
- It describes one capsule fitted into the morning routine and one into the evening routine.Ofev HCP dosing
- If you miss a dose
The Patient Information says to take your next dose at your regular time and not to take the missed dose.
- It also says not to take more than 300mg of Ofev in 1 day.FDA label
- When side effects call for a lower dose
The label lets the prescriber lower the dose to 100mg twice a day, or pause treatment until a side effect settles.
- Treatment can then resume at 150mg, or at 100mg with a later return to 150mg.
- If 100mg twice a day is not tolerated, the label has the prescriber discontinue Ofev.FDA label
- Diarrhea, nausea and vomiting
The label tells prescribers to treat diarrhea at the first signs with fluids and an antidiarrheal medicine such as loperamide.
- The Patient Information says your doctor may recommend fluids or medicine for these side effects.
- It also asks you to mention laxatives, stool softeners and supplements that can cause diarrhea.FDA label
- Medicines that change nintedanib levels
Ketoconazole raised nintedanib exposure by 60% in the label's study, and rifampicin cut it by 50%.
- The label says to avoid P-gp and CYP3A4 inducers such as carbamazepine, phenytoin and St. John's wort.
- With inhibitors such as erythromycin, it asks the prescriber to watch closely for side effects.
- The Patient Information says to show your medicine list to your doctor and pharmacist with each new medicine.FDA label
- Blood thinners, steroids and NSAIDs
The label asks prescribers to watch people on full anticoagulation closely for bleeding.
- It asks for caution in people taking corticosteroids or NSAIDs, because of the risk of a tear in the stomach or intestine.
- The Patient Information says to tell your doctor about blood thinners, including over-the-counter aspirin.FDA label
- Alongside pirfenidone
The label says nintedanib and pirfenidone did not change each other's blood levels, so no dose change is needed.
- In a 12-week study of 105 people, stomach and bowel side effects affected 70% on both drugs against 53% on nintedanib alone.
- Liver enzyme rises to 3 times the upper limit or more were reported in 3 people (6%) on both drugs and none on nintedanib alone.FDA label
- Pregnancy, birth control and breastfeeding
The Patient Information says women should not become pregnant while taking Ofev.
- Birth control pills may not work as well during vomiting or diarrhea, and it says to ask your doctor about another highly effective method.
- The label says breastfeeding is not recommended during treatment.
- It also says that, based on animal studies, Ofev may reduce fertility in women who could become pregnant.FDA label
- Kidney conditions
The label says no change to the starting dose is needed with mild or moderate kidney impairment.
- Ofev has not been studied in severe kidney impairment, meaning a creatinine clearance under 30mL/min, or in end-stage kidney disease.FDA label
- Brand or generic
FDA records show the first generic nintedanib capsules were approved on April 2, 2026, from 5 companies.Drugs@FDA generics
- Reporting a side effect
The label lists Boehringer Ingelheim at 1-800-542-6257 and the FDA at 1-800-FDA-1088 for reporting side effects.
- The Patient Information also says to call your doctor for medical advice about side effects.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit.
- The Patient Information says to keep Ofev dry and protect it from high heat.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 problems
Yellow skin or eyes, dark or tea-colored urine, upper right stomach area pain, easier bleeding or bruising, tiredness or appetite loss.
- The Patient Information says to call your doctor right away.
- In the IPF trials, liver enzyme rises were reported in 14% on Ofev against 3% on placebo.FDA label
Diarrhea, nausea and vomiting
Diarrhea affected 62% of people on Ofev against 18% on placebo, nausea 24% against 7% and vomiting 12% against 3%.
- The label asks patients to contact their provider at the first signs of diarrhea, or for any severe or lasting symptoms.
- In the IPF trials, diarrhea led to a permanently lower dose in 11% on Ofev and to stopping in 5%.FDA label
Symptoms of a heart attack or stroke
Chest pain or pressure, pain in the arms, back, neck or jaw, or shortness of breath can be symptoms of a heart problem.
- Numbness or weakness on 1 side of the body, trouble talking, headache or dizziness can be symptoms of a stroke.
- The Patient Information says to tell your doctor right away, and the label stresses the urgency of seeking immediate medical care.
- Heart attacks were reported in 1.5% on Ofev against 0.4% on placebo in the IPF trials.FDA label
Unusual bleeding
The Patient Information says to tell your doctor about unusual bleeding, bruising or wounds that do not heal.
- Bleeding events were reported in 10% on Ofev against 7% on placebo in the IPF trials, most often nosebleeds across the trials.
- Among reports since approval, the label lists bleeding events, some of which were fatal.FDA label
Other common side effects in the IPF trials
Stomach area pain affected 15% on Ofev against 6% on placebo, and decreased appetite 11% against 5%.
- Weight loss affected 10% against 3%, headache 8% against 5%, and high blood pressure 5% against 4%.FDA label
Pain or swelling in the stomach area
The Patient Information lists these as signs of a tear in the stomach or intestinal wall and says to tell your doctor.
- A tear was reported in less than 1% of people on Ofev in the IPF trials, and fatal cases have been reported since approval.FDA label
Foamy urine, swelling or sudden weight gain
The Patient Information lists foamy urine, swelling in the hands, arms, legs or feet, and sudden weight gain as signs of protein in the urine.
- It says to tell your doctor about any of them.
- Heavy protein loss in the urine has been reported since approval.FDA label
A pregnancy, or too many capsules
The Patient Information says to tell your doctor right away about a pregnancy or a suspected one.
- After taking too much Ofev, it says to call your doctor or go to the nearest hospital emergency room right away.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 nintedanib firstOn Cigna's employer plans, brand Ofev is approved only after generic nintedanib was tried. The policy also requires an inactive ingredient difference that would cause a significant allergy or serious adverse 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
- The plan wants pirfenidone firstOn Cigna's individual and family plans, starting nintedanib or Ofev for IPF requires that pirfenidone tablets were tried and cannot be taken. People already started on the medicine meet the rule without that step. The pulmonologist's office can tell the plan which situation applies.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 at baseline, 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
- Ofev was prescribed alongside pirfenidoneCigna lists nintedanib taken with pirfenidone, sold as Esbriet or generic, as not medically necessary. The same policy does allow Jascayd (nerandomilast) to be taken alongside nintedanib. Combining treatments is the pulmonologist's decision, and the office can explain it to the plan.Cigna policy
- Insurance is slow to decideThe OFEV Bridge Program gives a free 15-day supply, with up to 3 more 15-day refills, during a payer delay. Boehringer counts a benefit check or approval pending 7 calendar days or longer, or a denial under appeal. To be eligible, patients must be insured and meet certain income requirements.Access for Ofev
- A copay you cannot payWith commercial insurance, the OFEV Commercial Copay Program can lower the cost to as little as $0 per month. Medicare, Medicaid, Tricare, VA and other government-funded plans are excluded, and so are people paying cash. The Boehringer Ingelheim Cares Foundation gives free medicine to people who meet its eligibility criteria, at 1-800-556-8317. Our help paying page lists charity funds.Access for Ofev
- The prescription went to the wrong pharmacyBoehringer's prescriber site says Ofev is available through partnering specialty pharmacies. It lists Accredo, AllianceRX Walgreens, CenterWell, CVS/Caremark, Optum and Orsini. The office faxes the completed Prescription Form to the specialty pharmacy.Access for Ofev
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
- Employer plans: for brand Ofev, generic nintedanib tried first, and an inactive ingredient difference that would cause a significant allergy or serious adverse reaction
- Individual and family plans: for generic nintedanib or brand Ofev, pirfenidone tablets tried and cannot be taken, unless the patient has already started the medicine
- Not used together with pirfenidone (Esbriet or generic), although Jascayd (nerandomilast) alongside is allowed
Approval length. Approved a year at a time, and renewal needs age 18 or older, a pulmonologist and a beneficial response over the past year. On employer plans, renewal of brand Ofev must also meet the generic-first rule. 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 July 30, 2026 that made no criteria changes. It cites the May 2025 Ofev label, the same revision this page uses. The policy also covers progressive pulmonary fibrosis and lung disease from systemic sclerosis, each with its own criteria. 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.
- Enrollment online, by phone, by texting START to 84537, or by a form faxed to 844-880-OFEV (6338) or mailed
- Health resource support, described as available 24/7, to answer questions about treatment with Ofev
- Financial resource support, which explores financial assistance options and explains the prescription fulfillment process
- Social resource support, with periodic calls and help finding local services such as meal delivery or rides to appointments
- OFEV Commercial Copay Program for commercially insured patients, as little as $0 per month, with enrollment handled by the specialty pharmacy; not open to people on Medicare, Medicaid, Tricare, VA or other government-funded plans, or paying cash Access for Ofev
- OFEV Bridge Program, a free 15-day supply with up to 3 more 15-day refills during a payer delay of 7 calendar days or longer or a denial under appeal, for insured patients who meet certain income requirements Access for Ofev
- Boehringer Ingelheim Cares Foundation Patient Assistance Program, free medicine for patients who meet its eligibility criteria, at 1-800-556-8317, Monday to Friday, 8:30 AM to 6:00 PM Eastern Boehringer Cares
- Independent charities, which Boehringer says may help people on government drug plans, without insurance, or whose private plan does not cover Ofev Access for Ofev
Details as the drugmaker publishes them. CareConnect4Me
Five questions for the pharmacist or the support line
- Is this prescription for brand Ofev or generic nintedanib, and which one does my plan cover?
- I take these medicines and supplements. Do any of them affect P-gp or CYP3A4, the way St. John's wort or ketoconazole does?
- I take a blood thinner, aspirin, a steroid or an NSAID. Is that on the list my pulmonologist has?
- Which specialty pharmacy will ship Ofev, and when does the refill for the 60-capsule bottle go out?
- If my doctor lowers the dose to 100mg, does that need a new prescription and a new approval?
Questions people ask in the first weeks
How is Ofev taken?
The label gives one 150mg capsule twice a day, about 12 hours apart, with food. Capsules are swallowed whole with liquid and are not chewed, crushed or opened. The label gives no build-up schedule, so the full dose starts on day 1.
Do I need blood tests on Ofev?
Yes, the label asks for liver blood tests of ALT, AST and bilirubin before the first dose. It repeats them at regular intervals during the first 3 months, then periodically, and whenever liver symptoms appear. Anyone who could become pregnant also has a pregnancy test before starting.
How common is diarrhea on Ofev?
In the IPF trials, diarrhea affected 62% of people on Ofev against 18% on placebo. The label says it was mild to moderate in most people and began within the first 3 months. The label tells prescribers to treat it at the first signs with fluids and an antidiarrheal such as loperamide.
What if I miss a dose of Ofev?
The Patient Information says to take your next dose at your regular time and not to take the missed dose. It also says not to take more than 300mg of Ofev in 1 day.
Is there a generic version of Ofev?
Yes, FDA records show the first generic nintedanib capsules were approved on April 2, 2026, from 5 companies. On Cigna's employer plans, brand Ofev is covered only after generic nintedanib was tried and cannot be taken. The reason must be an inactive ingredient difference that would cause a significant allergy or serious adverse reaction. Which version fits is a question for the pulmonologist and the plan.
Does smoking affect Ofev?
Yes, in the label's analysis current smokers had 21% lower nintedanib exposure than former smokers and people who never smoked. The label says that may change how well Ofev works. It asks people to stop smoking before treatment and avoid it while taking Ofev.
Can Ofev be taken during pregnancy?
The Patient Information says Ofev can cause birth defects or death to an unborn baby, and women should not become pregnant while taking it. The label calls for a pregnancy test first and highly effective birth control until at least 3 months after the last dose. It asks for a call to the doctor right away about a pregnancy.
Is there a REMS for Ofev?
No, the label sets no REMS, and none of the 7 FDA approval letters reviewed for this page mentions one. The office faxes a Prescription Form to a specialty pharmacy, and Boehringer lists 6 partnering specialty pharmacies.
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Sources
- OFEV- nintedanib capsule: prescribing information, revised 5/2025, and Patient Information, revised May 2025, Boehringer Ingelheim Pharmaceuticals, Inc., via DailyMed, November 20, 2025.
- OFEV (nintedanib capsules) prescribing information, revised 10/2024, FDA, accessdata.fda.gov, October 11, 2024.
- CARECONNECT4ME™ Patient Support Program | OFEV® (nintedanib), Boehringer Ingelheim Pharmaceuticals, Inc., November 11, 2026.
- Access Support & Prescribing Assistance | OFEV® (nintedanib), Boehringer Ingelheim Pharmaceuticals, Inc., November 11, 2026.
- Dosage Recommendations | OFEV® (nintedanib) capsules, Boehringer Ingelheim Pharmaceuticals, Inc., November 11, 2026.
- Boehringer Cares Patient Assistance Portal | Boehringer Ingelheim US, Boehringer Ingelheim Cares Foundation, via Boehringer Ingelheim, November 11, 2026.
- Drug Coverage Policy IP0312, Nintedanib (Pulmonary, Antifibrotics, Nintedanib), Cigna, September 15, 2026.
- Drugs@FDA records for generic nintedanib applications (ANDA), via openFDA, FDA, November 11, 2026.
- Drugs@FDA: FDA-Approved Drugs, New Drug Application (NDA) 205832, FDA, November 11, 2026.
- NDA 205832/S-028 supplement approval letter, posterior reversible encephalopathy syndrome, FDA, October 11, 2024.
- NDA 205832/S-027 supplement approval letter, pediatric use, FDA, June 18, 2024.
- NDA 205832/S-016 supplement approval letter, proteinuria and capsule handling, FDA, January 13, 2022.
- NDA 205832/S-014 supplement approval letter, oral contraception and drug-drug interaction, FDA, October 28, 2020.
- NDA 205832/S-013 supplement approval letter, chronic fibrosing interstitial lung diseases with a progressive phenotype, FDA, March 9, 2020.
- NDA 205832/S-012 supplement approval letter, systemic sclerosis-associated interstitial lung disease, FDA, September 6, 2019.
- NDA 205832 approval letter, Ofev capsules for idiopathic pulmonary fibrosis, 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.