Brinsupri (brensocatib) is filed as Dipeptidyl peptidase 1 inhibitor. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older. ( 1 )
Brensocatib is a competitive, reversible inhibitor of dipeptidyl peptidase 1 (DPP1).
5 WARNINGS AND PRECAUTIONS Dermatologic Adverse Reactions : Monitor for new rash or skin conditions and refer to dermatology for evaluation. ( 5.1 ) Gingival and Periodontal Adverse Reactions : Gingival and periodontal adverse reactions can occur with BRINSUPRI use. Refer to the dental care services for regular dental checkups and advise patients to perform routine dental hygiene. ( 5.2 ) Live Attenuated Vaccines : It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of the vaccines. Avoid use of live attenuated vaccines. ( 5.3 ) 5.1 Dermatologic Adverse Reactions Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis [see Adverse Reactions (6.1) ]. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings. 5.2 Gingival and Periodontal Adverse Reactions Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions [see Adverse Reactions (6.1) ]. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene. 5.3 Live Attenuated Vaccines The concomitant use of BRINSUPRI and live attenuated vaccines has not been evaluated. It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.
4 CONTRAINDICATIONS None. None. ( 4 )
Upper respiratory tract infection (≥2%); Headache (≥2%); Rash (≥2%); Dry skin (≥2%); Hyperkeratosis (≥2%); Hypertension (≥2%)
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Dermatologic Adverse Reactions [see Warnings and Precautions (5.1) ] Gingival and Periodontal Adverse Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥2%): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Insmed Incorporated at 1-844-4-INSMED or FDA at 1-800-FDA-1088 or https://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 the clinical trials of another drug and may not reflect the rates observed in practice. The safety data below reflect the safety of BRINSUPRI in adult and pediatric patients aged 12 years and older with non-cystic fibrosis bronchiectasis (NCFB). A total of 1721 patients with NCFB were randomized in a double-blind, placebo-controlled clinical trial of 52 weeks duration (ASPEN) [see Clinical Studies (14) ]. The safety of BRINSUPRI was based on data from 1719 adult and pediatric patients aged 12 years and older who received at least one dose of BRINSUPRI or placebo. A total of 1156 patients received at least one dose of BRINSUPRI 10 mg or 25 mg orally once daily. Table 1 shows the adverse reactions occurring at an incidence of ≥2% and higher in BRINSUPRI-treated patients compared to placebo in the safety population from ASPEN. Table 1 Adverse Reactions with BRINSUPRI with an Incidence of ≥2% and More Common than Placebo in ASPEN Adverse Reaction Placebo (N=563) n (%) BRINSUPRI 10 mg QD (N=582) n (%) BRINSUPRI 25 mg QD (N=574) n (%) Upper respiratory tract infection Upper respiratory tract infection includes coronavirus infection, COVID-19, influenza, upper respiratory tract infection, viral infection, and viral upper respiratory tract infection. 141 (25) 157 (27) 169 (29) Headache 39 (7) 39 (7) 49 (9) Rash Rash includes rash, rash maculo-papular, rash pruritic, rash erythematous, dermatitis, and erythema. 22 (4) 25 (4) 35 (6) Dry skin Dry skin includes dry skin, chapped lips, cheilitis, lip dry, skin exfoliation, skin fissures, xeroderma, and xerosis. 8 (1) 17 (3) 25 (4) Hyperkeratosis Hyperkeratosis includes hyperkeratosis, palmoplantar keratoderma, and skin hypertrophy. 5 (1) 8 (1) 16 (3) Hypertension 17 (3) 28 (5) 13 (2) Adverse Reactions in WILLOW A total of 256 adult patients with NCFB were randomized in the 24-week, double-blind, placebo-controlled clinical trial (WILLOW). Of those randomized, 255 adult patients received BRINSUPRI 10 mg, BRINSUPRI 25 mg, or placebo, which consisted of 170 adults treated with at least one dose of BRINSUPRI 10 mg or 25 mg orally once daily. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, with the exception of a higher incidence of gingival and periodontal adverse reactions. The incidence of gingival and periodontal adverse reactions in WILLOW among patients treated with BRINSUPRI 10 mg and 25 mg were 9.9% and 10.1%, respectively, compared to 2.4% in placebo-treated patients. Less Common Adverse Reactions Liver Function Test Elevations In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3× upper limit of normal (ULN) was 0%, 1.2%, and 0.9%, in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. The incidence of AST >3× ULN was 0.2%, 0.3%, and 0.5% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. The incidence of alkaline phosphatase >1.5× ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. Skin Cancers In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients. Alopecia In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6%, respectively, compared to 0.4% in placebo-treated patients.
2 DOSAGE AND ADMINISTRATION Recommended dosage: 10 mg or 25 mg orally once daily with or without food. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of BRINSUPRI is as follows: 10 mg orally once daily with or without food or 25 mg orally once daily with or without food Missed Dose(s) Patients who miss a dose should take the next dose at their regular time the next day. Do not double the dose to make up for the missed dose.
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Dermatologic Adverse Reactions Inform patients that BRINSUPRI is associated with a risk of adverse skin reactions including rash, dry skin, and hyperkeratosis. Advise patients to monitor their skin and report any new rash or skin condition [see Warnings and Precautions (5.1) ] . Gingival and Periodontal Adverse Reactions Inform patients that BRINSUPRI is associated with a risk of gingival and periodontal adverse reactions. Advise patients to have regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene [see Warnings and Precautions (5.2) ] . Live Attenuated Vaccines Instruct patients to inform the healthcare provider that they are taking BRINSUPRI prior to a potential vaccination [see Warnings and Precautions (5.3) ] .
According to its FDA label, Brinsupri (brensocatib) is approved for: 1 INDICATIONS AND USAGE BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronc… For medical advice, please talk to your prescriber or pharmacist.
Brinsupri (brensocatib) belongs to the Dipeptidyl peptidase 1 inhibitor class of medications.
The FDA label lists Brinsupri (brensocatib) as: 3 DOSAGE FORMS AND STRENGTHS Tablets: 10 mg, brown, round, film-coated tablets debossed with "10" on one side and "BRE" on the other 25 mg, gray, round, film-coated tablets debossed with "25" on one side and "BRE" on the other Tablets: 10 mg and 25 mg ( 3 ); oral route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Brinsupri. Availability changes as patents expire.
Our ingest of the FDA label for Brinsupri (brensocatib) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Brinsupri (brensocatib) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Brinsupri (brensocatib) as 2025-08-12.
The FDA label lists Insmed Incorporated as a labeler/manufacturer of Brinsupri (brensocatib). Multiple firms may market generics of the same molecule.
The FDA label states: "Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in original container." Follow the packaging insert for the authoritative guidance.
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