Brensoacatib is an orally administered selective dipeptidyl peptidase 1 (DPP1) inhibitor that reduces neutrophil serine protease (NSP) activation by inhibiting DPP1 activity, thereby alleviating neutrophil mediated inflammatory responses.

1、 Drug name

1. Common name: Brensoacatib

2. Product Name: BRINUPRI

2、 Indications

Used for the treatment of non cystic fibrotic bronchiectasis (NCFB) in adult and pediatric patients aged 12 years and above.

3、 Specifications

1、10mg、25mg。

2. Packaging: 30 tablets/bottle.

4、 Main components

Active ingredient: Brensoacatib monohydrate.

5、 Usage and dosage

1. Recommended dosage: 10mg or 25mg, taken orally once daily, can be taken with food or separately.

2. Omission: If missed, take the next dose at the regular time the next day and do not double the dosage.

6、 Dose adjustment

There is currently no clear dosage adjustment plan for adverse reactions or special populations.

7、 Medication precautions

1. Both before and after meals: No special requirements.

2. Leakage of service: see Article 5.

8、 Medication for special populations

1. Pregnant women: No human data available. In animal experiments, fetal malformations (curved scapula) were observed in rats exposed to 128 times the maximum recommended human dose (MRHD); When the exposure level of rabbits reached 20 times MRHD, no developmental adverse effects were observed.

2. Breastfeeding period: It is unknown whether it has entered human milk, and the pros and cons need to be weighed.

3. Children: efficacy and safety have been established for patients aged 12 and above; The effectiveness and safety of children under 12 years old have not been established.

4. Elderly patients: There is no difference in safety and efficacy between patients aged 65 and above (51% of the treatment population) and young adults.

9、 Adverse reactions

1. Common adverse reactions (incidence ≥ 2% and higher than placebo): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension.

2. Other adverse reactions: gingival and periodontal adverse reactions (with an incidence rate of about 10% in another trial), elevated ALT/AST/alkaline phosphatase, skin cancer, hair loss.

10、 Contraindications

None.

11、 Drug interactions

1. Strong CYP3A4/P-gp inhibitors (such as clarithromycin): Increased blood concentration of brexostat (Cmax ↑ 68%, AUC ↑ 55%).

2. Intermediate acting CYP3A4/P-gp inhibitors (such as verapamil): Cmax increased by 53%, AUC increased by 32%.

3. Strong CYP3A4 inducers (such as rifampicin): Cmax ↓ 15%, AUC ↓ 33%.

4. Acid reducing agents (such as esomeprazole): No significant effect.

5. Live attenuated vaccine: Avoid simultaneous use as safety and efficacy are unknown.

6. Brisoprolol has no significant effect on CYP3A4 substrates such as midazolam.

12、 Storage method

1. Storage temperature: 20 ° C to 25 ° C (68 ° F to 77 ° F); allowable offset to 15 ° C – 30 ° C (59 ° F – 86 ° F).

2. Store in the original bottle, away from light and moisture.

Brensocatibinformation