Brinsupri®
Brensocatib is a dipeptidyl peptidase 1 (DPP1) inhibitor.1
Brensocatib has the following uses:
Brensocatib is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years of age and older.1
Brensocatib is available in the following dosage form(s) and strength(s):
Tablets: 10 mg and 25 mg1
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Adults and Pediatric Patients 12 Years of Age and Older
Recommended dosage is 10 mg or 25 mg orally once daily with or without food.1
None.1
Dermatologic Adverse Reactions
Treatment with brensocatib is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis.1 Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.1
Gingival and Periodontal Adverse Reactions
Treatment with brensocatib is associated with an increase in gingival and periodontal adverse reactions.1 Refer patients to dental care services for regular dental checkups while taking brensocatib.1 Advise patients to perform routine dental hygiene.1
The concomitant use of brensocatib and live attenuated vaccines has not been evaluated.1 It is unknown whether administration of live attenuated vaccines during brensocatib treatment will affect the safety or effectiveness of these vaccines.1 The use of live attenuated vaccines should be avoided in patients receiving brensocatib.1
There are no available data on brensocatib use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.1
In animal embryo fetal development (EFD) studies, oral administration of brensocatib to pregnant rats during organogenesis at maternal exposures 128 times the maximum recommended human dose (MRHD) on an AUC basis was associated with malformations.1 Oral administration of brensocatib to pregnant rabbits during organogenesis demonstrated no adverse developmental effects at doses that produced maternal exposures up to 20 times the MRHD.1 No adverse development effects were observed after oral administration of brensocatib to pregnant rats from the period of organogenesis through lactation at doses that produced maternal exposures 17 times the MRHD on an AUC basis.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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.1
There are no data on the presence of brensocatib and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production.1
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for brensocatib and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.1
The safety and effectiveness of brensocatib for the treatment of non-cystic fibrosis bronchiectasis (NCFB) have been established in pediatric patients 12 years of age and older.1 Use of brensocatib for this indication is supported by evidence from an adequate and well-controlled trial (ASPEN), which enrolled 41 pediatric patients 12 years of age and older, and additional pharmacokinetic data in pediatric patients 12 to 17 years of age. 1
Common adverse reactions in pediatric patients 12 years of age and older enrolled in ASPEN were consistent with those in adults.1
The safety and effectiveness of brensocatib have not been established in pediatric patients younger than 12 years of age.1
There were 988 patients 65 years of age and older in the clinical studies for non-cystic fibrosis bronchiectasis.1 Of the total number of brensocatib-treated patients in these studies, 676 (51%) were 65 years of age and older while 201 (15%) were 75 years of age and older.1 There were no observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients.1
Most common adverse reactions (incidence ≥2%): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension.1
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:
Please see product labeling for drug interaction information.
Brensocatib is a competitive, reversible inhibitor of dipeptidyl peptidase 1 (DPP1).1 DPP1 activates pro-inflammatory neutrophil serine proteases (NSPs) during neutrophil maturation in the bone marrow.1 Activated NSPs are implicated in the pathogenesis of neutrophil-mediated non-cystic fibrosis bronchiectasis (NCFB) inflammation.1 In cell-based assays, DPP1 inhibition by brensocatib reduces the activity of NSPs including neutrophil elastase, cathepsin G, and proteinase 3.1
Additional Information
AHFS first Release™. 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 drug 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 | 10 mg | Brinsupri® | Insmed |
25 mg | Brinsupri® | Insmed |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions October 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.