Nerandomilast
Generic Name: nerandomilast
Brand Names:
Jascayd
11 DESCRIPTION JASCAYD (nerandomilast tablets), for oral administration, contain nerandomilast, a phosphodiesterase 4 (PDE4) inhibitor. The chemical name of nerandomilast is [1-[[(5R)-2-[4-(5-chloropyrimidin-2-yl)-1-piperidyl]-5-oxo-6,7-dihydrothieno[3,2-d]pyrimidin-4-yl]amino]cyclobutyl]methanol. Nerandomilast has one chiral center and is the R-stereoisomer.
Overview
11 DESCRIPTION JASCAYD (nerandomilast tablets), for oral administration, contain nerandomilast, a phosphodiesterase 4 (PDE4) inhibitor. The chemical name of nerandomilast is [1-[[(5R)-2-[4-(5-chloropyrimidin-2-yl)-1-piperidyl]-5-oxo-6,7-dihydrothieno[3,2-d]pyrimidin-4-yl]amino]cyclobutyl]methanol. Nerandomilast has one chiral center and is the R-stereoisomer.
Uses
1 INDICATIONS AND USAGE JASCAYD is a phosphodiesterase 4 (PDE4) inhibitor indicated for: The treatment of idiopathic pulmonary fibrosis in adult patients. ( 1.1 ) The treatment of progressive pulmonary fibrosis in adult patients. ( 1.2 ) 1.1 Idiopathic Pulmonary Fibrosis JASCAYD is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients. 1.2 Progressive Pulmonary Fibrosis JASCAYD is indicated for the treatment of progressive pulmonary fibrosis (PPF) in adult patients.
Dosage
2 DOSAGE AND ADMINISTRATION Recommended Dosage : 18 mg orally twice daily approximately 12 hours apart with or without food. ( 2.1 ) Reduce JASCAYD to 9 mg twice daily for patients who are unable to tolerate 18 mg twice daily, except in patients taking concomitant pirfenidone. ( 2.1 , 7.1 ) Swallow tablets whole or dispersed in water. ( 2.1 ) See full prescribing information for dosage modification for concomitant use with CYP3A inhibitors and administration instructions for patients who have difficulty swallowing tablets. ( 2.2 , 2.3 ) 2.1 Recommended Dosage The recommended dosage of JASCAYD is 18 mg twice daily, administered orally (swallow tablets whole or dispersed in water) approximately 12 hours apart, with or without food.
Side Effects
6 ADVERSE REACTIONS 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
Interactions
7 DRUG INTERACTIONS Strong CYP3A Inhibitors : Reduce JASCAYD dosage to 9 mg twice daily. ( 2.2 , 7.1 ) Moderate or Strong CYP3A Inducers : Avoid concomitant use with JASCAYD. ( 7.1 ) 7.1 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 [see Dosage and Administration (2.2) ] . 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 [see Clinical Pharmacology (12.3) ]. Moderate or Strong CYP3A Inducers Avoid use of JASCAYD with strong or moderate CYP3A inducers. Nerandomilast is a CYP3A substrate.
Warnings
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy 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). Based on findings from animal reproduction studies, JASCAYD may increase the risk for fetal loss.
Storage
Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original container to protect from light.
Frequently Asked Questions
What is Nerandomilast used for?▼
1 INDICATIONS AND USAGE JASCAYD is a phosphodiesterase 4 (PDE4) inhibitor indicated for: The treatment of idiopathic pulmonary fibrosis in adult patients. ( 1.1 ) The treatment of progressive pulmonary fibrosis in adult patients. ( 1.2 ) 1.1 Idiopathic Pulmonary Fibrosis JASCAYD is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients. 1.2 Progressive Pulmonary Fibrosis JASCAYD is indicated for the treatment of progressive pulmonary fibrosis (PPF) in adult patients.
What are the side effects of Nerandomilast?▼
6 ADVERSE REACTIONS 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
Can I take Nerandomilast during pregnancy?▼
8.1 Pregnancy 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). Based on findings from animal reproduction studies, JASCAYD may increase the risk for fetal loss.
What are the important warnings for Nerandomilast?▼
4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.