Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Insmed Netherlands B.V., Stadsplateau 7, 3521 AZ Utrecht, Netherlands
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.
The recommended dose is 25 mg orally once daily with or without food.
Patients who miss a dose should take the next dose at their regular time the next day. Patients should not double the dose to make up for the missed dose.
No dose adjustment is required for elderly patients (see section 5.2).
No dose adjustment is required for patients with renal or hepatic impairment (see section 5.2).
The safety and efficacy of Brinsupri in children younger than 12 years of age have not yet been established. No data are available.
For oral use.
This medicinal product should be taken once daily with or without food.
Doses of up to 120 mg, given as a single dose, did not have evidence of dose-related toxicities.
There is no specific treatment for an overdose with brensocatib. If an overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
18 months.
Store in the original package in order to protect from moisture.
PVC/PCTFE aluminium foil blister card containing 14 film-coated tablets.
Pack size of 28 tablets (2 blister cards of 14 tablets each) in a carton.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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