Brinsupri 10 mg/1
Brensocatib · TABLET · Insmed Incorporated
Brinsupri is a tablet containing brensocatib at 10 mg/1, taken oral. Manufactured by Insmed Incorporated.
Key Facts
- Brand Name
- Brinsupri
- Generic Name
- Brensocatib
- NDC Code (Product)
71558-001- Manufacturer
- Insmed Incorporated
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA217673
- Marketing Start
- 08/12/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 )
Dosage & Administration
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.
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
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…
Frequently Asked Questions
What is Brinsupri used for?
Brinsupri contains Brensocatib. It is a tablet taken oral. Consult your doctor for specific uses.
Is Brinsupri a controlled substance?
Brinsupri is not classified as a controlled substance by the DEA.
What is the generic name for Brinsupri?
The generic name for Brinsupri is Brensocatib. There are no other listed brand versions of Brensocatib.
What is the NDC code for Brinsupri 10 mg/1?
The NDC (National Drug Code) for Brinsupri 10 mg/1 is 71558-001, listed by Insmed Incorporated.
Other Brinsupri Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)