Safety and tolerability in PPF
MOST COMMON AEs
JASCAYD® had a favorable tolerability and safety profile1
- JASCAYD® treatment does not require liver or lab monitoring at treatment initiation2
ADVERSE EVENTS IN ≥10% OF JASCAYD® PATIENTS AND MORE OFTEN THAN PLACEBO1
Placebo +/- nintedanib (n=392) | JASCAYD® 18 mg +/- nintedanib (n=391) | |
|---|---|---|
| Diarrhea | 26% | 37% |
| Cough | 16% | 17% |
| Weight decreased | 8% | 14% |
| Pneumonia | 11% | 13% |
| Nausea | 7% | 12% |
| Anxiety | 11% | 12% |
ADVERSE EVENTS IN ≥10% OF JASCAYD® PATIENTS AND MORE OFTEN THAN PLACEBO1
Placebo +/- nintedanib (n=392) | JASCAYD® 9 mg +/- nintedanib (n=393) | |
|---|---|---|
| Diarrhea | 26% | 33% |
| Cough | 16% | 14% |
| Weight decreased | 8% | 10% |
| Pneumonia | 11% | 11% |
| Nausea | 7% | 9% |
| Anxiety | 11% | 11% |
RISK OF INFECTION
JASCAYD® demonstrated a lower risk of upper respiratory tract infection compared to placebo1
OVERALL POPULATION1
Placebo (n=392) | JASCAYD® 18 mg (n=391) | |
|---|---|---|
| Risk of upper respiratory tract infection | 17% | 14% |
OVERALL POPULATION1
Placebo (n=392) | JASCAYD® 9 mg (n=393) | |
|---|---|---|
| Risk of upper respiratory tract infection | 17% | 12% |
FREQUENCY OF DIARRHEA
Frequency of diarrhea was dependent on the presence of background nintedanib2
The most frequent adverse event associated with JASCAYD® was diarrhea, and in most cases it was mild to moderate in intensity and generally occurred within the first 3 months2
The most frequent adverse event associated with JASCAYD® was diarrhea, and in most cases it was mild to moderate in intensity and generally occurred within the first 3 months2
Only 1% of patients taking JASCAYD® without nintedanib discontinued treatment due to diarrhea events1
OTHER SAFETY AND TOLERABILITY CONSIDERATIONS
Safety and tolerability considerations when prescribing JASCAYD®2
Psychological disorders are common in PPF and IPF. While no imbalance was seen with JASCAYD® vs placebo in psychiatric events, routine monitoring is recommended2
Quicklinks
References
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Wijsenbeek MS, Assassi S, Azuma A, Cottin V, Hoffmann-Vold AM, Maher TM, Martinez FJ, Oldham JM, Richeldi L, Valenzuela C, Gu H, Ritter I, Stowasser S, Kreuter M. Nerandomilast in progressive pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-ILD trial. Eur Respir J. Published online March 26, 2026.
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JASCAYD® UAE Local SmPC; May 2026.
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Wijsenbeek MS, Assassi S, Azuma A, et al. Effect of nerandomilast on clinical outcomes in patients with progressive pulmonary fibrosis (PPF): results from the final database lock of the FIBRONEER-ILD trial. 2025. Presented at: European Respiratory Society (ERS) International Congress; September 2025; Vienna, Austria. Poster available from: https://www.globalmedcomms.com/respiratory/ERS2025/Wijsenbeek1.
MLR ID: PC-AE-102895
Expiry Date: 10/05/2028