Jascayd®
Nerandomilast is a phosphodiesterase 4 (PDE4) inhibitor.1
Nerandomilast has the following uses:
Nerandomilast is indicated for the treatment of idiopathic pulmonary fibrosis in adult patients.1
Nerandomilast is available in the following dosage form(s) and strength(s):
Tablets: 9 mg and 18 mg1
None.1
There are no available data on nerandomilast use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.1 There are maternal and fetal risks associated with untreated idiopathic pulmonary fibrosis during pregnancy.1 Based on findings from animal reproduction studies, nerandomilast may increase the risk for fetal loss.1 In an embryo-fetal development study in rats, oral administration of nerandomilast to pregnant rats during organogenesis at an exposure approximately 5 times the maximum recommended human dose (MRHD) of 36 mg/day resulted in an increase in embryo-fetal losses.1 Advise pregnant women and females of reproductive potential of the potential risk of fetal loss.1, 1
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.1 All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.1 In the U.S.1 general population, the estimated background risk of major birth defects is 2% to 4% and miscarriage in clinically recognized pregnancies is 15% to 20%.1
Untreated idiopathic pulmonary fibrosis can lead to respiratory failure and mortality in the mother and intrauterine growth restriction, preterm birth, fetal hypoxia, and neonatal death.1
There are no data on the presence of nerandomilast or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.1 Nerandomilast is present in animal milk.1 When a drug is present in animal milk, it is likely that the drug will be present in human milk.1 The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for nerandomilast and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.1
The safety and effectiveness of nerandomilast for the treatment of idiopathic pulmonary fibrosis have not been established in pediatric patients.1
There were 930 patients 65 years of age and older in the FIBRONEER-IPF trial.1 Of the total number of nerandomilast-treated patients in this trial, 623 (79%) were 65 years of age and older, while 251 (32%) were 75 years of age and older.1 No overall differences in safety or effectiveness of nerandomilast have been observed between patients 65 years of age and older and younger adult patients
Nerandomilast has not been investigated in patients with severe (Child-Pugh Class C) hepatic impairment.1 Use of nerandomilast is not recommended in patients with severe (Child-Pugh Class C) hepatic impairment.1 The recommended dosage in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment is the same as that in patients with normal hepatic function.1
Nerandomilast has not been investigated in patients with end stage renal disease (eGFR <15 mL/min/1.73 m2).1 Use of nerandomilast is not recommended in patients with end stage renal disease (eGFR <15 mL/min/1.73 m2).1 The recommended dosage in patients with mild (eGFR ≥60 to <90 mL/min/1.73 m2 according to CKD-EPI), moderate (eGFR ≥30 to <60 mL/min/1.73 m2or severe renal impairment (eGFR ≥15 to <30 mL/min/1.73 m2) is the same as that in patients with normal renal function.1
Most common adverse reactions (≥5%) are diarrhea, COVID-19, upper respiratory tract infection, depression, weight decreased, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.1
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this Nerandomilast, including possible dosage adjustments. Interaction highlights:
Nerandomilast is an inhibitor of phosphodiesterase 4 (PDE4) with at least 9-fold preferential inhibition of the PDE4B isoenzyme over PDE4A, PDE4C and PDE4D based on in vitro data.1 PDE4 hydrolyzes and inactivates cyclic adenosine monophosphate (cAMP).1 Nerandomilast exerts both anti-fibrotic and immunomodulatory effects as PDE4B inhibition elevates intracellular cAMP levels and reduces the expression of pro-fibrotic growth factors and inflammatory cytokines, which are overexpressed in idiopathic pulmonary fibrosis.1
Additional Information
AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential Nerandomilast interactions, laboratory test interferences, and acute toxicity.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 9 mg | Jascayd® | Boehringer Ingelheim |
18 mg | Jascayd® | Boehringer Ingelheim |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions December 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.