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Brand Name :
Jascayd
Synonyms :
nerandomilast
Class :
Phosphodiesterase-4 Enzyme Inhibitors
Brand Name :
Jascayd
Synonyms :
nerandomilast
Class :
Phosphodiesterase-4 Enzyme Inhibitors
Adult dosing
Dosage forms & strengths
Tablets
18 mg
9 mg
Used for the management of idiopathic pulmonary fibrosis (IPF)
Administer 18 mg orally twice daily, If the patient experiences intolerance at this dose, the regimen may be decreased to 9 mg taken twice daily
When used with pirfenidone, continue with 18 mg orally twice daily; dose reduction to 9 mg twice daily is not recommended
Pediatric dosing
Safety and efficacy are not established
Geriatric dosing
Refer to adult dosing
Action and spectrum:
It acts as a phosphodiesterase 4 (PDE4) inhibitor, showing a selective affinity for the PDE4B isoenzyme. This selectivity contributes to its antifibrotic and immunomodulatory effects. By blocking PDE4B activity, the drug increases intracellular cyclic AMP (cAMP) concentrations, leading to a reduction in pro-fibrotic growth factors and inflammatory cytokines that are typically elevated in idiopathic pulmonary fibrosis (IPF).
Frequency Defined
1-10%
Vasculitis (1%)
Amylase increased (1%)
Asthenia (4-5%)
Dizziness (5-6%)
Back pain (5-6%)
Vomiting (5-6%)
Headache (6-7%)
Fatigue (7-8%)
Nausea (8-9%)
Decreased appetite (9%)
>10%
Weight decreased (10-11%)
Depression (11-12%)
Upper respiratory tract infection (11-13%)
Respiratory infection, COVID-19 (13-16%)
Diarrhea (31-42%)
Black Box Warning
None
Contraindication/Caution:
Contraindication
None
Cautions
Drug interactions
Pregnancy Warnings:
Pregnancy category: N/A
Lactation: Excretion in human breastmilk is unknown
Pregnancy categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology:
It acts as a phosphodiesterase 4 (PDE4) inhibitor, showing a selective affinity for the PDE4B isoenzyme. This selectivity contributes to its antifibrotic and immunomodulatory effects. By blocking PDE4B activity, the drug increases intracellular cyclic AMP (cAMP) concentrations, leading to a reduction in pro-fibrotic growth factors and inflammatory cytokines that are typically elevated in idiopathic pulmonary fibrosis (IPF).
Pharmacokinetics:
Absorption
After oral administration, the drug exhibits a bioavailability of approximately 73%, with peak plasma concentrations achieved within 1 to 1.25 hours. A steady-state level is typically reached after about four days of consistent dosing.
Distribution
About 77% of the drug binds to plasma proteins, and it has an apparent volume of distribution (Vd) of around 93 L.
Metabolism
The drug undergoes hepatic metabolism, mainly through the CYP3A enzyme system, with minor contributions from multiple UGT enzymes. A chiral inversion process converts the pharmacologically active R-enantiomer; the major circulating form into the inactive S-enantiomer, which is a minor metabolite.
Excretion and Elimination
For elimination, the drug has a half-life of approximately 17 hours and a clearance rate of about 15.2 L/hour. Excretion occurs primarily through the feces (58%), with 14% excreted unchanged, and through the urine (36%), with 13% unchanged.
Administration:
The mode of administration is oral.
Patient information leaflet
Generic Name: nerandomilast
Why do we use nerandomilast?
Nerandomilast is being developed for the treatment of idiopathic pulmonary fibrosis, a chronic, progressive lung disease characterized by scarring (fibrosis) of the lung tissue.
It helps reduce inflammation and fibrosis by inhibiting PDE4, which increases intracellular cAMP levels and modulates inflammatory pathways.
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