Jascayd

Jascayd (nerandomilast) is a prescription medication used to treat adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), helping slow lung function decline by reducing inflammation and lung scarring (fibrosis) through its anti-fibrotic and immunomodulatory effects. It is not known if Jascayd is safe and effective in children.

Jascayd tablets are taken twice daily with or without food.

Jascayd is a phosphodiesterase 4 (PDE4) inhibitor. It works by preferentially inhibiting phosphodiesterase-4B (PDE4B), an enzyme involved in inflammatory and fibrotic signaling pathways in the lungs.

Idiopathic pulmonary fibrosis is a chronic, progressive lung disease that causes scarring (fibrosis) of the lung tissue and leads to increasing shortness of breath.

Pulmonary fibrosis (PPF) is another form of pulmonary fibrosis with an underlying clinical interstitial lung disease diagnosis (ILD), such as autoimmune ILD or hypersensitivity pneumonitis.

Jascayd FDA approval for IPF was granted on October 7, 2025, following positive results from the clinical trials FIBRONEER-IPF (NCT05321069) and Trial 2 (NCT04419506). The FIBRONEER-IPF trials demonstrated that Jascayd 18mg patients experienced a statistically significant reduction in the decline in absolute change from baseline in FVC over 52 weeks versus the placebo group (FVC reduction Jascayd 114.7 mL vs 183.5 ml placebo)

Approval for PPF was based on the FIBRONEER-ILD clinical trial (NCT05321082), which reported significant treatment benefit for lung function decline with Jascayd versus placebo (86-69mL FVC reduction vs 152mL placebo) with similar discontinuation rates (8-10% across groups).

• Take this medicine exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Jascayd to take and when to take it.
• Take tablets either with or without food.
• Jascayd tablets should be swallowed whole.
• If you cannot swallow tablets whole:

Before taking this medicine, tell your healthcare provider about all of your medical conditions, including if you have:

• kidney problems.
• liver problems.

Pregnancy

Tell your healthcare professional if you are pregnant or planning to become pregnant. Jascayd may cause loss of your pregnancy (miscarriage). It is not known if this medicine can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant while taking Jascayd.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breastmilk. You and your healthcare provider should decide if you will take Jascayd or breastfeed.

The most common Jascayd side effects are:

Other side effects may include weakness, inflamed blood vessels (vasculitis), irregular heartbeat (atrial fibrillation), increased amylase levels, and cancers such as non-melanoma skin cancer and small cell lung cancer.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Recommended Dosage: 18 mg orally twice daily approximately 12 hours apart with or without food.

Dose modification:

• Reduce Jascayd dose to 9 mg twice daily for patients who are unable to tolerate 18 mg twice daily, except in patients taking concomitant moderate CYP3A inducers or pirfenidone.
• Strong CYP3A Inhibitors. Reduce Jascayd dosage to 9 mg twice daily when used concomitantly with strong CYP3A inhibitors.

Jascayd is available as 9mg tablets and 18mg tablets.

• If you miss a dose, take your next dose at your regular time.
• Do not take the missed dose.
• Do not take more than two 18 mg Jascayd tablets in 1 day.

If you take too much Jascayd, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Strong CYP3A Inhibitors: Reduce Jascayd dosage to 9 mg twice daily.

Strong CYP3A Inducers: Avoid using Jascayd with strong CYP3A Inducers. For moderate CYP3A inducers, the recommended dosage is 18 mg twice daily (do not reduce dosage to 9 mg twice daily).

Pirfenidone (Esbriet)

Not all possible drug interactions are listed here.

HCPs and patients often use the Jascayd Prescribing Information for more detailed information about this medicine. The Prescribing Information contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interactions, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Prescribing Information is sometimes called the Jascayd Package Insert or FDA label.

• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Store tablets in the original child-resistant container to protect it from light.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany

Active ingredient: nerandomilast

Inactive ingredients: croscarmellose sodium, ferric oxide red (18 mg tablets only), ferric oxide yellow (9 mg tablets only), ferrosoferric oxide (18 mg tablets only), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, and talc. Each tablet contains less than 5 mg of sodium.