Your first 90 days
Your first 90 days on Jascayd 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.
Jascayd has no safety program, no vaccine and no blood test standing between the prescription and the first fill. What it does have is one dose rule that depends on your other lung medicines. Diarrhea, its most common side effect, usually shows up in the first 3 months. In the main trial, 78% of patients already took pirfenidone or nintedanib (Ofev), and the label treats each of those differently. This page lays out those first weeks from the FDA label, Boehringer Ingelheim's own program pages and one insurer's written rules.
What has to happen before the first bottle ships
Jascayd has no REMS, so the first fill waits on an insurance approval, an enrollment form and a specialty pharmacy, not on a lab result. These are the 5 things in the way, in order.
A medicine list, with pirfenidone and CYP3A in mind
Nerandomilast is broken down mostly by a liver enzyme called CYP3A.
- The label lowers the dose to 9mg twice a day with a strong CYP3A blocker and says to avoid strong CYP3A inducers.
- Pirfenidone lowers the lowest level of nerandomilast between doses by about half, which is why the label keeps the dose at 18mg alongside it.FDA label
Kidney and liver conditions
The label does not recommend Jascayd for people with end stage kidney disease, an eGFR below 15, or with severe liver impairment.
- Mild to severe kidney impairment and mild or moderate liver impairment need no dose change.FDA label
Pregnancy and mood history
Rat studies showed pregnancy loss at about 5 times the highest human dose, and the label asks prescribers to explain that risk.
- The IPF trials excluded people with severe depression or suicidal thoughts or behavior, which makes any history worth raising with the pulmonologist.FDA label
The insurance approval
Plans such as the Blue Cross Blue Shield Federal Employee Program require prior approval.
- Its policy asks for lung function tests and a high-resolution CT scan with definite or probable usual interstitial pneumonia.
- It also asks for a pulmonologist and a check for drug interactions.FEP Blue policy
One form for the prescription and CareConnect4Me
The office sends Boehringer Ingelheim's Prescription and Patient Support Program Enrollment Form online through CoverMyMeds or by fax.
- The patient checks a box on it to join CareConnect4Me, which then checks eligibility for the copay and bridge programs.Access for Jascayd
The days that matter
Counted from the first dose, with the refill every 30 days and the 3-month stretch when diarrhea is most likely to start. 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.Insurance approval
The plan reviews the prior approval request with the lung function results and the CT report.
- Under the FEP policy, the pulmonologist also documents a drug interaction check.
Enrollment form and specialty pharmacy
The enrollment form goes to CoverMyMeds or straight to a specialty pharmacy.
- Boehringer lists 6 partner specialty pharmacies, including Accredo, CVS Specialty and Optum Specialty Pharmacy.
First dose, 18mg twice a day
One 18mg tablet in the morning and one about 12 hours later, with or without food.
- The tablet can be swallowed whole or stirred into water, and there is no build-up period first.
Refill, then every 30 days
A bottle holds 60 tablets, which is 30 days at 2 tablets a day.
- The label lists the same 60-tablet bottle for both the 9mg and 18mg strengths.
Refill, number 2
Three months in
In the trials, diarrhea was mostly mild or moderate and generally began within the first 3 months.
- Weight loss and a smaller appetite were also more common than on placebo.
Refill, number 3
Renewal for FEP members
The FEP policy approves Jascayd for 6 months at first.
- Renewal asks the prescriber to say whether lung function decline slowed, symptoms held steady or well-being improved.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Jascayd 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 August 14, 2026, read from the FDA's label database today. FDA label
- August 2026
The dose rule for moderate CYP3A inducers changed after 2 drug interaction trials. The February 2026 label said to avoid moderate and strong inducers alike. The new label keeps 18mg twice a day with a moderate inducer and still says to avoid strong ones.FDA letter
- February 2026
The IPF labeling was harmonized with the progressive pulmonary fibrosis application, in the FDA letter's words. That separate application had been approved by the FDA on December 19, 2025.FDA letter
- December 2025
Progressive pulmonary fibrosis was approved as a second use, under a separate FDA application that was then folded into the main one.FDA letter
- October 2025
Jascayd was first approved for idiopathic pulmonary fibrosis in adults. The FDA asked Boehringer for further trials of how pirfenidone and CYP3A inducers change nerandomilast levels.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 or without food
The label gives 18mg twice a day, about 12 hours apart, with or without food.
- A high-fat meal made no meaningful difference to blood levels in the label's study.FDA label
- If swallowing tablets is hard
The Patient Information says to drop a tablet, uncrushed, into 3 to 4 ounces of non-carbonated room temperature water, and no other liquid.
- Stir it regularly for 15 to 20 minutes and drink it within 2 hours.
- Then rinse the glass with the same amount of water and drink that too.FDA label
- If you miss a dose
The Patient Information says to take the next dose at your regular time and not to take the missed dose.
- It also says never to take more than two 18mg tablets in 1 day.FDA label
- When 18mg is hard to tolerate
The label lets the prescriber lower the dose to 9mg twice a day.
- That lower dose is not used with pirfenidone or with a moderate CYP3A inducer, because both lower nerandomilast levels.
- In the main trial, 9mg taken with pirfenidone showed no benefit.FDA label
- Alongside pirfenidone or Ofev
The main trial let people stay on pirfenidone or nintedanib, sold as Ofev.
- Results for 18mg matched the overall trial in each group.
- Diarrhea was more common in people who were also taking nintedanib alongside it.FDA label
- Medicines that change the dose
Itraconazole, a strong CYP3A blocker, raised nerandomilast exposure 2.2 times, and the label lowers the dose to 9mg with drugs like it.
- Carbamazepine, a strong inducer, cut exposure by 51%, and the label says to avoid strong inducers.
- The pharmacist needs to hear about every new medicine, even a short course of an antifungal like itraconazole.FDA label
- Pregnancy and breastfeeding
The Patient Information says Jascayd may cause loss of a pregnancy and asks you to tell the provider right away about a pregnancy.
- Whether it passes into breast milk is unknown, and that decision is shared with the prescriber.FDA label
- 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 the doctor for medical advice about side effects.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit, in the original child-resistant bottle, which protects the tablets from light.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.
Diarrhea
Diarrhea affected 42% of people on 18mg and 31% on 9mg, against 17% on placebo.
- With nintedanib it reached 62% on 18mg against 28% on placebo, and with pirfenidone 24% against 8%.
- Most cases were mild or moderate, and the Patient Information says to call the doctor for advice about side effects.FDA label
Low mood or thoughts of suicide
Depression, a grouped term that includes suicidal thoughts, was reported in 12% on 18mg against 10% on placebo.
- The label has no warning about it, but the trials excluded people with severe depression or suicidal thoughts.
- Any change in mood is worth telling the pulmonologist about.FDA label
Weight loss and a smaller appetite
Weight loss affected 11% on 18mg against 8% on placebo, and decreased appetite 9% against 5%.
- Weight loss was most common with nintedanib, at 16% on 18mg against 12% on placebo.FDA label
A pregnancy, or too many tablets
The Patient Information says to tell the provider right away about a pregnancy.
- After taking too much, it says to call the provider or Poison Help at 1-800-222-1222, or go to the nearest 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.
- Prior authorization pending or deniedThe FEP policy asks for age 18 or older, a pulmonologist, lung function tests and a CT scan showing definite or probable usual interstitial pneumonia. It also asks for no known cause of the fibrosis and a documented drug interaction check. The office sends the lung function and CT reports along with the request.FEP Blue policy
- The lung function numbers do not match the policyThe FEP policy asks for an FVC or DLCO of 90% of predicted or lower, with a pre-bronchodilator FEV1/FVC ratio of 70% or more. The pulmonologist's office can check which result the plan read and resend the full report.FEP Blue policy
- Insurance is slow to decideThe JASCAYD Bridge Program gives a free 30-day supply and up to 1 more 30-day refill during a coverage delay. Boehringer's prescriber pages give the delay as at least 5 days on one page and 7 calendar days on another. People without insurance for specialty drugs, or paying cash, do not qualify.Access for Jascayd
- A copay you cannot payWith commercial insurance, the JASCAYD Copay Program can lower the cost to as little as $0 a month. Medicare, Medicaid, TRICARE, VA and other government plans are excluded. For uninsured or underinsured people, the Boehringer Ingelheim Cares Foundation runs a free-drug program with income rules, and our help paying page lists charity funds.Access for Jascayd
- The prescription went to the wrong pharmacyBoehringer's prescriber site has offices send Jascayd prescriptions through CoverMyMeds or to a specialty pharmacy. It lists Accredo, Walgreens Specialty, CenterWell, CVS Specialty, Optum Specialty and Orsini as partner pharmacies. A prescription sent elsewhere is a routing problem, and the office resends it.Access for Jascayd
Blue Cross Blue Shield Federal Employee Program prior authorization policy, April 1, 2026
- Age 18 years of age or older
- Idiopathic pulmonary fibrosis (IPF)
- Idiopathic (i.e., no identifiable cause for pulmonary fibrosis) diagnosis confirmed by ALL of the following: physical exam; pulmonary function tests with %FVC ≤ 90% of predicted OR %DLCO ≤ 90% of predicted, and pre-bronchodilator FEV1/FVC ratio ≥ 70%; high-resolution computed tomography (HRCT) with definite or probable findings of usual interstitial pneumonitis (UIP)
- Prescribed by or recommended by a pulmonologist
- Drug interaction assessment has been performed by the physician
- NO known cause of the interstitial lung disease / fibrosis
Approval length. 6 months for the first approval, then 12 months at a time. Renewal needs the prescriber's assessment that it is helping, by slowed lung function decline, no worse cough or shortness of breath, or a better sense of well-being, plus a drug interaction assessment.
The FEP committee approved this version on March 6, 2026, and it took effect April 1, 2026. Its web address sits in fepblue.org's October 2026 policy folder. It cites the December 2025 label, so it predates the August 2026 change for moderate CYP3A inducers. The March 2026 review says it removed dual PA medications for IPF. Other plans set their own criteria and their own approval lengths for Jascayd. It is here as an example of what a plan asks for, not as a rule. FEP Blue 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.
- CareConnect4Me Copay Program for commercially insured patients, who may pay as little as $0 per fill
- Copay Program exclusions, any government-funded plan such as Medicare, Medicaid, TRICARE or VA, and people paying cash Access for Jascayd
- JASCAYD Bridge Program, a free 30-day supply and up to 1 more 30-day refill during an insurance delay of at least 5 days, for people whose insurance covers specialty drugs Access for Jascayd
- Bridge terms on Boehringer's CareConnect4Me page, a documented delay of 7 calendar days or more, a denial with an appeal within 30 days, or a lapse from changing plans, for people 12 or older in the US or Puerto Rico
- BI Cares Patient Assistance Program, free Jascayd for eligible uninsured or underinsured people who meet income and coverage rules, run by the Boehringer Ingelheim Cares Foundation Access for Jascayd
- A patient navigator with 24/7 availability, plus Patient and Community Clinical Educators who meet at home, by phone or on Zoom Support services
- Information on the Medicare Prescription Payment Plan and the RE Assist tool for independent foundations
Details as the drugmaker publishes them. CareConnect4Me
Five questions for the pharmacist or the support line
- I also take pirfenidone or Ofev. Does my prescription account for that?
- I take these medicines. Are any of them strong CYP3A blockers or inducers, such as itraconazole or carbamazepine?
- Which specialty pharmacy will ship Jascayd, and what number will the delivery call come from?
- If my insurance is slow, can CareConnect4Me start the bridge supply?
- Can I stir the tablet into water if swallowing is hard, and how do I do it?
Questions people ask in the first weeks
How is Jascayd taken?
The label gives one 18mg tablet twice a day, about 12 hours apart, with or without food. Tablets are swallowed whole or stirred into water for people who have trouble swallowing, with no build-up period.
Can Jascayd be taken with pirfenidone or Ofev?
Yes, the main trial included people on pirfenidone or nintedanib (Ofev), and results for 18mg matched the overall trial. With pirfenidone, the label keeps the dose at 18mg because 9mg showed no benefit. With nintedanib, diarrhea was more common, at 62% on 18mg.
Does Jascayd need blood tests?
No, the label sets no routine lab monitoring, and it has no boxed warning or contraindications. Some plans, such as the FEP plan, ask at renewal whether the decline in lung function has slowed.
What are the most common side effects of Jascayd?
In the main IPF trial, diarrhea led the list at 42% on 18mg against 17% on placebo. COVID-19, upper respiratory infections, depression, weight loss and decreased appetite were also more common than on placebo. In the trial, diarrhea was mostly mild or moderate and generally began in the first 3 months.
What if I miss a dose of Jascayd?
The Patient Information says to take the next dose at your regular time and not to take the missed dose. It also says never to take more than two 18mg tablets in 1 day.
How much does Jascayd cost with insurance?
With commercial insurance, the JASCAYD Copay Program can bring the cost to as little as $0. Medicare, Medicaid, TRICARE, VA and other government plans are excluded from that program. The Boehringer Ingelheim Cares Foundation runs a separate free-drug program for eligible uninsured or underinsured people.
Is there a REMS for Jascayd?
No, neither the label nor the FDA approval letters set a REMS. The office sends the prescription through CoverMyMeds or to a specialty pharmacy, and Boehringer lists 6 partner specialty pharmacies.
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Sources
- JASCAYD- nerandomilast tablet, film coated: prescribing information, revised 8/2026, and Patient Information, revised 12/2025, Boehringer Ingelheim Pharmaceuticals, Inc., via DailyMed, August 14, 2026.
- JASCAYD (nerandomilast tablets) prescribing information, revised 02/2026, FDA, accessdata.fda.gov, February 26, 2026.
- JASCAYD® (nerandomilast) tablets | CareConnect4Me, Boehringer Ingelheim Pharmaceuticals, Inc., November 9, 2026.
- How to Access | JASCAYD® (nerandomilast) tablets, Boehringer Ingelheim Pharmaceuticals, Inc., November 9, 2026.
- Support Services | JASCAYD® (nerandomilast) tablets, Boehringer Ingelheim Pharmaceuticals, Inc., November 9, 2026.
- Pharmacy Policy 5.45.019, Jascayd, Blue Cross Blue Shield Federal Employee Program, April 1, 2026.
- NDA 218764/S-002 supplement approval letter, CYP3A inducer dosing, FDA, August 14, 2026.
- NDA 218764/S-001 supplement approval letter, labeling harmonized with NDA 220449, FDA, February 26, 2026.
- NDA 220449 approval letter, progressive pulmonary fibrosis, FDA, December 19, 2025.
- NDA 218764 approval letter, idiopathic pulmonary fibrosis, FDA, October 7, 2025.
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.