Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

JASCAYD (NDA-218764)

(NERANDOMILAST)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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08/14/2026 (SUPPL-2)

Approved Drug Label (PDF)

7 Drug Interactions

Additions and/or revisions underlined:

Strong or Moderate CYP3A Inducers

Avoid concomitant use of strong CYP3A inducers with JASCAYD.

Recommended dosage of JASCAYD is 18 mg twice daily when used concomitantly with moderate CYP3A inducers. Do not reduce the dosage to 9 mg twice daily [see Dosage and Administration (2.1)].

Nerandomilast is a CYP3A substrate. Concomitant use of JASCAYD with strong or moderate CYP3A inducers decreases exposure of nerandomilast, which may decrease the efficacy of JASCAYD [see Clinical Pharmacology (12.3)].

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02/26/2026 (SUPPL-1)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

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Adverse Reactions for Idiopathic Pulmonary Fibrosis

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Specific Adverse Reactions of JASCAYD for IPF with or without Concomitant Use of Nintedanib or Pirfenidone

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Less Common Adverse Reactions in IPF

Less common adverse reactions in the IPF population following administration of JASCAYD included asthenia (5% JASCAYD 18 mg twice daily, 4% JASCAYD 9 mg twice daily, and 2% placebo), amylase increased (1% JASCAYD 18 mg twice daily, 1% JASCAYD 9 mg twice daily, and 0% placebo), and vasculitis (1% JASCAYD 18 mg twice daily, 1% JASCAYD 9 mg twice daily, and 0% placebo).

Adverse Reactions for Progressive Pulmonary Fibrosis

The safety of JASCAYD was based on a randomized, placebo-controlled, double-blind trial (FIBRONEER-ILD), in which 1,178 adult patients with PPF were randomized in a 1:1:1 ratio to receive JASCAYD 9 mg twice daily, JASCAYD 18 mg twice daily, or matching placebo. Patients received JASCAYD or placebo with or without background nintedanib treatment for at least 52 weeks [see Clinical Studies (14.2)]. The median duration of exposure was 15 months in each treatment arm.

The most common adverse reactions in patients with PPF treated with JASCAYD were generally consistent with those observed in patients with IPF.

Specific Adverse Reactions of JASCAYD for PPF with or without Concomitant Use of Nintedanib

Diarrhea

Diarrhea was more common in patients using JASCAYD with concomitant nintedanib. In patients taking nintedanib, diarrhea occurred in 49%, 50%, and 37% of patients treated with JASCAYD 18 mg twice daily, JASCAYD 9 mg twice daily, and placebo, respectively. In patients without concomitant use of nintedanib, diarrhea occurred in 27%, 16%, and 16% of patients using JASCAYD 18 mg twice daily, JASCAYD 9 mg twice daily, and placebo, respectively.

Diarrhea was the most common adverse reaction associated with treatment discontinuation, and most common with JASCAYD used concomitantly with nintedanib: discontinuation occurred in 4%, 3%, and 1% in patients treated with JASCAYD 18 mg twice daily, JASCAYD 9 mg twice daily, and placebo, respectively. Diarrhea leading to treatment discontinuation occurred in 1% of patients treated with JASCAYD 18 mg twice daily and in no patients treated with JASCAYD 9 mg or placebo without concomitant use of nintedanib.

In most patients treated with JASCAYD, diarrhea was of mild to moderate intensity and generally occurred within the first 3 months of treatment.

Weight Decrease

Weight decrease was more common in patients who received JASCAYD concomitantly with nintedanib, which occurred in 12%, 10%, and 9% of patients treated with JASCAYD 18 mg twice daily, JASCAYD 9 mg twice daily, and placebo, respectively. In patients without concomitant use of nintedanib, weight decrease occurred in 13%, 8%, and 5% of patients treated with JASCAYD 18 mg twice daily, JASCAYD 9 mg twice daily, and placebo, respectively.

Malignancies

Among patients with PPF, neoplasms (benign, malignant, or unspecified) were reported in more patients with PPF treated with JASCAYD than placebo over the entire study duration of FIBRONEER-ILD (5% JASCAYD 18 mg, 5% JASCAYD 9 mg, and 3% placebo). Malignancies such as non-melanoma skin cancers and small cell lung cancer were observed in patients who received JASCAYD (basal cell carcinoma: JASCAYD 18 mg n=2 [1%] vs. JASCAYD 9 mg n=3 [1%] vs. placebo n=1 [0.3%]; squamous cell carcinoma of skin: JASCAYD 18 mg n=4 [1%] vs. JASCAYD 9 mg n=2 [0.5%] vs. placebo n=0; and small cell lung cancer: JASCAYD 18 mg n=4 [1%] vs. JASCAYD 9 mg and placebo n=0).

Less Common Adverse Reaction(s) in PPF

Less common adverse reactions in the PPF population following administration of JASCAYD include atrial fibrillation (3% JASCAYD 18 mg twice daily, 2% JASCAYD 9 mg twice daily, and <1% placebo).

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

There are no available data on JASCAYD use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are maternal and fetal risks associated with untreated idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) during pregnancy (Clinical Considerations).

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Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Untreated IPF or PPF can lead to respiratory failure and mortality in the mother and intrauterine growth restriction, preterm birth, fetal hypoxia, and neonatal death.

8.4 Pediatrics

Additions and/or revisions underlined:

The safety and effectiveness of JASCAYD for the treatment of idiopathic pulmonary fibrosis or progressive pulmonary fibrosis have not been established in pediatric patients.

8.5 Geriatric Use

Additions and/or revisions underlined:

There were 930 patients 65 years of age and older in the FIBRONEER-IPF trial [see Clinical Studies (14.1)]. Of the total number of JASCAYD-treated patients with idiopathic pulmonary fibrosis in this trial, 623 (79%) were 65 years of age and older, while 251 (32%) were 75 years of age and older.

There were 733 patients 65 years of age and older in the FIBRONEER-ILD trial [see Clinical Studies (14.2)]. Of the total number of JASCAYD-treated patients with progressive pulmonary fibrosis in this trial, 490 (63%) were 65 years of age and older, while 150 (19%) were 75 years of age and older.

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17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

What is JASCAYD?

JASCAYD is a prescription medicine used:

to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).

to treat adults with a lung disease called progressive pulmonary fibrosis (PPF).

It is not known if JASCAYD is safe and effective in children.

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What are the ingredients in JASCAYD?

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Each tablet contains less than 5 mg of sodium.