Brensocatib: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 13, 2026🚩 Report this page

Brensocatib

Active ingredient

Sold as Brinsupri

GB MHRAEU EMA

Drug class: -
Availability: See label
Markets covered: 2
Products on record: 2

Overview

Brensocatib is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	April 13, 2026
EU European Union	EMA	1	December 4, 2025

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised April 13, 2026[1]

Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised December 4, 2025[2]

Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.

How to take

Sources & citations

[1]MHRA (UK) · PL474340002 · revised April 13, 2026
[2]European Medicines Agency · EMEA/H/C/005820 · revised December 4, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 13, 2026[1]

0%). Tabulated list of adverse reactions The safety of brensocatib was evaluated on the pooled safety population from two placebo-controlled clinical trials, ASPEN and WILLOW, which consisted of 1 326 adult and 41 adolescent patients 12 years of age and older with NCFB who received at least one dose of brensocatib for up to 52 weeks.
The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Adverse reactions System organ class Frequency Adverse reaction Infections and infestations Common Upper respiratory tract infection Gastroenteritis Nervous system disorders Common Headache Gastrointestinal disorders Common Gingival disorder Periodontal disease System organ class Frequency Adverse reaction Skin and subcutaneous tissue disorders Common Hyperkeratosis* Rash Dry skin Dermatitis Skin exfoliation Alopecia * See ‘Description of selected adverse reactions’ below.
1%). All events were of mild or moderate severity. Most resolved with no action taken with study treatment. Most cases were manageable or improved/resolved with emollients or topical steroids. 1). The safety profile in these adolescents was similar to that observed in adults.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised April 13, 2026[1]

Immunocompromised patients Safety data in patients with known or suspected immunodeficiencies, immunocompromised conditions, or receiving any immunomodulatory therapy are limited or not established. Administration of brensocatib in these patients should be considered with caution.
Caution is advised when using brensocatib in patients with moderate to severe neutropenia (absolute neutrophil count [ANC] < 1,000/mm³). Vaccinations The concomitant use of brensocatib and live attenuated vaccines has not been evaluated.
The use of live attenuated vaccines should be avoided in patients receiving brensocatib. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised December 4, 2025[2]

0%). Tabulated list of adverse reactions The safety of brensocatib was evaluated on the pooled safety population from two placebo-controlled clinical trials, ASPEN and WILLOW, which consisted of 1 326 adult and 41 adolescent patients 12 years of age and older with NCFB who received at least one dose of brensocatib for up to 52 weeks.
The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Adverse reactions System organ class Frequency Adverse reaction Infections and infestations Common Upper respiratory tract infection Gastroenteritis Nervous system disorders Common Headache Gastrointestinal disorders Common Gingival disorder Periodontal disease Skin and subcutaneous tissue disorders Common Hyperkeratosis* Rash Dry skin Dermatitis Skin exfoliation Alopecia * See ‘Description of selected adverse reactions’ below.
1%). All events were of mild or moderate severity. 1). The safety profile in these adolescents was similar to that observed in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised December 4, 2025[2]

1%). Immunocompromised patients The safety of brensocatib has not been established in immunocompromised patients. Caution is advised when using brensocatib in patients with moderate to severe neutropenia (absolute neutrophil count [ANC] < 1,000/mm³).
Vaccinations The concomitant use of brensocatib and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving brensocatib. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.