ADVERSE REACTIONS
- The most common adverse reactions with an incidence of ≥5% in patients treated with JASCAYD were diarrhea, COVID-19, upper respiratory tract infection, depression, weight decreased, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.
DRUG INTERACTIONS
Effects of Other Drugs on JASCAYD
- Strong CYP3A Inhibitors: Reduce the dosage of JASCAYD to 9 mg twice daily when used concomitantly with strong CYP3A inhibitors. Nerandomilast is a CYP3A substrate. Concomitant use of JASCAYD with a strong CYP3A inhibitor increases exposure of nerandomilast, which may increase the risk of JASCAYD adverse reactions.
- Moderate or Strong CYP3A Inducers: Avoid use of JASCAYD with strong or moderate CYP3A inducers. Nerandomilast is a CYP3A substrate. Concomitant use of JASCAYD with moderate or strong CYP3A inducers is expected to decrease exposure of nerandomilast, which may decrease the efficacy of JASCAYD.
- Pirfenidone: Recommended dosage of JASCAYD is 18 mg twice daily when used concomitantly with pirfenidone. Do not reduce the dosage to 9 mg twice daily. Concomitant use of JASCAYD with pirfenidone decreases exposure of nerandomilast in patients with IPF. When JASCAYD was used concomitantly with pirfenidone in patients with IPF in FIBRONEER-IPF, efficacy was not observed with the JASCAYD 9 mg twice daily dosage.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Advise pregnant women and females of reproductive potential of the potential risk of fetal loss.
- Renal Impairment: Use of JASCAYD is not recommended in patients with end stage renal disease (eGFR <15 mL/minute/1.73 m2).
- Hepatic Impairment: Use of JASCAYD is not recommended in patients with severe (Child-Pugh Class C) hepatic impairment.
CL-JS-100016 12.19.2025
Please see full Prescribing Information for JASCAYD, including Patient Information.