Prescribing guide
Ofev (nintedanib)Liver monitoring, dose modification, P-gp and CYP3A4 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, a pregnancy test in females of reproductive potential, a P-gp and CYP3A4 medication review, smoking counseling, prior authorization and a Prescription Form faxed to a partnering specialty pharmacy.
Example PA threshold
Cigna IP0312 example: age 18 or older, FVC at least 40% predicted at baseline, UIP on HRCT or surgical biopsy, pulmonologist, generic nintedanib first for brand on employer plans, pirfenidone tablets first on individual and family plans, not with pirfenidone.
Monitoring
ALT, AST and bilirubin at baseline, at regular intervals for the first 3 months, then periodically and as clinically indicated; pregnancy status before and during treatment as appropriate; GI tolerability, bleeding, ischemia and proteinuria.
Support line
Boehringer Ingelheim CareConnect4Me 1-866-673-6366 (enrollment fax 844-880-OFEV (6338)), OFEV Commercial Copay Program to as little as $0 per month for commercial plans, OFEV Bridge Program of a 15-day supply with up to 3 more 15-day refills, Boehringer Cares 1-800-556-8317.
Give your patient their plan
A one-page handout for starting Ofev, 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/ofevBefore 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 sets no REMS and no restricted dispensing program, and none of the 7 FDA approval letters reviewed mentions one. The label has no boxed warning and no contraindications. | FDA label |
| Baseline liver panel | Conduct liver function tests (ALT, AST and bilirubin) in all patients before initiating treatment (sections 2.1 and 5.2). Postmarketing DILI, including severe liver injury with fatal outcome, is in section 5.2. | FDA label |
| Pregnancy test | Conduct a pregnancy test in females of reproductive potential before initiating treatment, and verify pregnancy status during treatment as appropriate (sections 2.1, 5.4 and 8.3). Based on animal data, Ofev may reduce fertility in females of reproductive potential (8.3). | FDA label |
| Hepatic impairment | Not recommended in moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Child Pugh A: 100mg twice daily, about 12 hours apart, with food. | FDA label |
| Medication reconciliation | Avoid P-gp and CYP3A4 inducers such as carbamazepine, phenytoin and St. John's wort. Monitor tolerability closely with P-gp and CYP3A4 inhibitors. Monitor patients on full anticoagulation closely for bleeding; caution with corticosteroids or NSAIDs. | FDA label |
| Smoking | Encourage patients to stop smoking before treatment and to avoid smoking while using Ofev; exposure was 21% lower in current smokers in the population PK analysis (sections 8.8 and 12.3). | FDA label |
| Specialty pharmacy | Fax the completed Prescription Form to a partnering specialty pharmacy: Accredo Health Group, AllianceRX Walgreens Pharmacy, CenterWell Pharmacy, CVS/Caremark, Optum or Orsini Healthcare. The pharmacy reviews coverage, checks whether prior authorization is required and delivers to the patient's home. | Access for Ofev |
| CareConnect4Me enrollment | Enrollment form by fax to 844-880-OFEV (6338) or by mail to P.O. Box 5070, Louisville, KY 40205-0070, online, or by phone at 1-866-673-6366 or text START to 84537. | CareConnect4Me |
| Payer delay | The OFEV Bridge Program provides a 15-day supply with up to 3 additional 15-day refills to insured patients who meet certain income requirements, for a benefit verification or payer approval outstanding 7 calendar days or longer, or a denial under appeal. | Access for Ofev |
| Brand or generic | Generic nintedanib 100mg and 150mg capsules were first approved on April 2, 2026 (Sandoz, Apotex, Dexcel, Cipla and Dr. Reddy's), per Drugs@FDA records. | Drugs@FDA generics |
| Therapeutic equivalents | Drugs@FDA lists AB-rated nintedanib capsules in both strengths from 9 applicants: Apotex, Biocon, Cipla, Dexcel, Dr. Reddy's, Glenmark, Humanwell PuraCap, Macleods and Sandoz. | Drugs@FDA |
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 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.
| 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 (nintedanib, Jascayd or pirfenidone) | 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, employer plans | For Ofev, a trial of generic nintedanib plus an inactive ingredient difference that would result in a significant allergy or serious adverse reaction | Generic fill history and a note naming the ingredient and the reaction | Cigna policy |
| Step, individual and family plans | For generic nintedanib or Ofev at IPF initiation, the patient has tried and cannot take pirfenidone tablets (Esbriet capsules or pirfenidone 534 tablets also count), or has already started therapy | Pirfenidone fill history and the reason it cannot be taken, or proof of current therapy | Cigna policy |
| Combination | Not covered with pirfenidone capsules or tablets (Esbriet 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 decline in FVC or six-minute walk distance, or in the number or severity of exacerbations; age 18 or older; on employer plans the preferred product criteria must still be met, so brand renewals face generic-first; approval for 1 year | Serial FVC or walk results against the pretreatment baseline | Cigna policy |
Ofev dosing and titration
| When | Label | Source |
|---|---|---|
| Recommended dose | 150mg orally twice daily, about 12 hours apart, with food. Swallow whole with liquid; do not chew, open or crush. | FDA label |
| Initiation | Boehringer's prescriber site states there is no up-titration upon initiation. | Ofev HCP dosing |
| Missed dose | Take the next dose at the next scheduled time; do not make up the missed dose. Do not exceed 300mg a day. | FDA label |
| Mild hepatic impairment | Child Pugh A: 100mg twice daily. Consider interruption or discontinuation for adverse reactions in these patients. | FDA label |
| Adverse reactions | Dose reduction to 100mg twice daily or temporary interruption until the reaction resolves; resume at 150mg twice daily, or at 100mg twice daily and later increase. Discontinue if 100mg twice daily is not tolerated. | FDA label |
| Diarrhea | Treat at first signs with adequate hydration and antidiarrheal medication (for example loperamide); consider dose reduction or interruption if it continues. Discontinue if severe diarrhea persists despite symptomatic treatment. | FDA label |
| Nausea and vomiting | Dose reduction or interruption may be required if symptoms persist despite supportive care including anti-emetics. Discontinue if severe nausea or vomiting does not resolve. | FDA label |
| Supply | 100mg (peach) and 150mg (brown) soft capsules in HDPE bottles of 60 with a child-resistant closure, NDC 0597-0143-60 and 0597-0145-60; one bottle is 30 days at 2 capsules a day. | FDA label |
| Earlier label | The October 2024 label posted at Drugs@FDA lists the same 60-capsule bottles. No approval letter is posted there for the May 2025 revision. | Earlier FDA label |
Monitoring the Ofev label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | ALT, AST and bilirubin; pregnancy test in females of reproductive potential | Required before initiation | FDA label |
| Months 1 to 3 | ALT, AST and bilirubin at regular intervals | The label names no fixed interval; the majority of hepatic events occur within the first 3 months | FDA label |
| After month 3 | ALT, AST and bilirubin periodically or as clinically indicated | Test promptly for fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice | FDA label |
| AST or ALT above 3 and below 5 times ULN, no signs of liver damage | Interrupt or reduce to 100mg twice daily | When enzymes return to baseline, reintroduce at 100mg twice daily, which may later be increased to 150mg twice daily | FDA label |
| AST or ALT above 3 times ULN with signs or symptoms of liver injury, or above 5 times ULN | Liver injury criteria | Discontinue | FDA label |
| Higher risk of enzyme elevation | Body weight under 65kg, Asian patients, female patients; exposure also rises with age | Section 5.2 | FDA label |
| First 3 months and after | Diarrhea (most cases begin in the first 3 months); nausea and vomiting at any time | IPF trials: diarrhea 62% against 18% on placebo, permanent dose reduction for diarrhea in 11%, discontinuation in 5% | FDA label |
| Any time | Signs of acute myocardial ischemia | Arterial thromboembolic events 2.5% against less than 1% in IPF trials; consider interruption; caution at higher cardiovascular risk | FDA label |
| Any time | Bleeding and GI perforation | Use with known bleeding or perforation risk only if benefit outweighs risk; discontinue if GI perforation develops. Postmarketing reports include bleeding events, some of which were fatal (6.2) | FDA label |
| Any time | Weight, appetite, blood pressure, headache | IPF trials, Ofev against placebo: abdominal pain 15% and 6%, decreased appetite 11% and 5%, weight decreased 10% and 3%, headache 8% and 5%, hypertension 5% and 4% | FDA label |
| Postmarketing | Reactions listed in section 6.2 | Thrombocytopenia, pancreatitis, posterior reversible encephalopathy syndrome, pruritus and rash; frequency cannot be reliably estimated | FDA label |
| Overdose | Section 10 | Interrupt treatment and initiate general supportive measures as appropriate | FDA label |
| Any time | New or worsening proteinuria | Nephrotic range proteinuria reported postmarketing; consider treatment interruption | FDA label |
Ofev drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| P-gp and CYP3A4 inhibitors (ketoconazole, erythromycin) | May increase exposure; ketoconazole raised it by 60%. Monitor closely for tolerability; manage adverse reactions by interruption, dose reduction or discontinuation. | FDA label |
| P-gp and CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St. John's wort) | Avoid; rifampicin decreased exposure by 50%. | FDA label |
| Anticoagulants | Nintedanib is a VEGFR inhibitor and may increase bleeding risk. Monitor patients on full anticoagulation closely and adjust anticoagulation as necessary. | FDA label |
| Corticosteroids and NSAIDs | Use caution because of GI perforation risk, as with recent abdominal surgery or a history of diverticular disease. | FDA label |
| Pirfenidone | No effect on exposure of either agent; no dose adjustment. In a 12-week open-label trial of 105 patients, GI adverse events occurred in 70% with add-on pirfenidone against 53% on nintedanib alone. AST or ALT at 3 times ULN or more was reported in 3 patients (6%) on the combination and none on nintedanib alone. | FDA label |
| Oral contraceptives | No change in exposure to ethinylestradiol and levonorgestrel, but vomiting or diarrhea may compromise efficacy; advise an alternative highly effective method. Contraception continues for at least 3 months after the last dose. | FDA label |
| Bosentan, PPIs and H2 antagonists | Bosentan did not alter nintedanib pharmacokinetics; proton pump inhibitors and H2 antagonists did not influence trough concentrations in the clinical trials. | FDA label |
| Smoking | Exposure 21% lower in current smokers; no dose adjustment, but the label says this may alter the efficacy profile. | FDA label |
| Renal impairment | No starting dose adjustment in mild to moderate impairment; not studied in severe impairment (CrCl below 30mL/min) or end-stage renal disease. | FDA label |
| Lactation | Breastfeeding is not recommended during treatment. | FDA label |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
CareConnect4Me (Boehringer Ingelheim)
- 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
Questions prescribers' offices ask about Ofev
What liver monitoring does the Ofev label require?
ALT, AST and bilirubin before initiation, at regular intervals during the first 3 months and periodically thereafter or as clinically indicated, per the May 2025 label (sections 2.1, 2.4 and 5.2). The label names no fixed interval. Test promptly if the patient reports fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
What is the Ofev dose and the reduced dose?
150mg twice daily, about 12 hours apart, with food, with no titration schedule in the label, and a reduced dose of 100mg twice daily for adverse reactions or for Child Pugh A hepatic impairment, per the May 2025 label. The maximum daily dose is 300mg and a missed dose is not made up. If 100mg twice daily is not tolerated, the label says to discontinue.
When does the Ofev label say to interrupt or stop for liver enzymes?
Discontinue for AST or ALT above 3 times ULN with signs or symptoms of liver injury, or above 5 times ULN, per the May 2025 label (section 2.4). For AST or ALT above 3 and below 5 times ULN without signs of liver damage, interrupt or reduce to 100mg twice daily. Once enzymes return to baseline, treatment may be reintroduced at 100mg twice daily and later increased.
Does Ofev have a REMS?
No. The May 2025 label has no REMS, no boxed warning and no contraindications, and none of the 7 FDA approval letters reviewed, from 2014 through 2024, mentions a REMS. The gates before the first fill are baseline liver tests, a pregnancy test in females of reproductive potential and the prior authorization.
What do insurers ask for to approve Ofev for IPF?
The Cigna policy shown here, effective September 15, 2026 and citing the May 2025 label, 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. Employer plans cover brand Ofev only after generic nintedanib was tried and cannot be taken because of an inactive ingredient difference that would cause a significant allergy or serious adverse reaction. Individual and family plans ask for a pirfenidone tablet trial first unless the patient is already on therapy.
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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, 2025-11-20.
- OFEV (nintedanib capsules) prescribing information, revised 10/2024, FDA, accessdata.fda.gov, 2024-10-11.
- CARECONNECT4ME™ Patient Support Program | OFEV® (nintedanib), Boehringer Ingelheim Pharmaceuticals, Inc., 2026-11-11.
- Access Support & Prescribing Assistance | OFEV® (nintedanib), Boehringer Ingelheim Pharmaceuticals, Inc., 2026-11-11.
- Dosage Recommendations | OFEV® (nintedanib) capsules, Boehringer Ingelheim Pharmaceuticals, Inc., 2026-11-11.
- Boehringer Cares Patient Assistance Portal | Boehringer Ingelheim US, Boehringer Ingelheim Cares Foundation, via Boehringer Ingelheim, 2026-11-11.
- Drug Coverage Policy IP0312, Nintedanib (Pulmonary, Antifibrotics, Nintedanib), Cigna, 2026-09-15.
- Drugs@FDA records for generic nintedanib applications (ANDA), via openFDA, FDA, 2026-11-11.
- Drugs@FDA: FDA-Approved Drugs, New Drug Application (NDA) 205832, FDA, 2026-11-11.
- NDA 205832/S-028 supplement approval letter, posterior reversible encephalopathy syndrome, FDA, 2024-10-11.
- NDA 205832/S-027 supplement approval letter, pediatric use, FDA, 2024-06-18.
- NDA 205832/S-016 supplement approval letter, proteinuria and capsule handling, FDA, 2022-01-13.
- NDA 205832/S-014 supplement approval letter, oral contraception and drug-drug interaction, FDA, 2020-10-28.
- NDA 205832/S-013 supplement approval letter, chronic fibrosing interstitial lung diseases with a progressive phenotype, FDA, 2020-03-09.
- NDA 205832/S-012 supplement approval letter, systemic sclerosis-associated interstitial lung disease, FDA, 2019-09-06.
- NDA 205832 approval letter, Ofev capsules for idiopathic pulmonary fibrosis, FDA, 2014-10-15.
A reference drawn from the November 20, 2025 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 11, 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.