Brensocatib Tablets are indicated for the treatment of non-cystic fibrosis bronchiectasis in adults and pediatric patients aged 12 years and older. NCFB is a chronic, progressive respiratory disease characterized by irreversible widening of the airways, leading to persistent cough, excessive sputum production, recurrent lung infections, and repeated exacerbations that can progressively impair lung function and quality of life. Brensocatib is the first DPP1 inhibitor approved for this indication and represents an important advancement in the management of this chronic inflammatory lung disease.

Before initiating treatment, patients should inform their healthcare provider about their complete medical history, including any ongoing infections, recent or planned live-attenuated vaccinations, pregnancy or breastfeeding status, and all concomitant medications. Regular clinical monitoring is recommended during therapy, particularly for dermatologic reactions and oral health, as skin-related and gingival or periodontal adverse reactions have been reported with Brensocatib treatment.

Brensocatib Tablets should only be used under the supervision of a qualified healthcare professional experienced in the management of chronic respiratory diseases. Patients are advised to follow the prescribed dosage regimen carefully and attend regular follow-up appointments to monitor treatment response, disease progression, and any potential adverse effects.

• Treat non-cystic fibrosis bronchiectasis (NCFB) in adults and adolescents aged 12 years and above.
• Reduce the frequency of pulmonary exacerbations (flare-ups) associated with bronchiectasis, helping patients experience fewer episodes of worsening respiratory symptoms.
• Reduce airway inflammation by inhibiting the activation of neutrophil serine proteases, enzymes that contribute to chronic inflammation and progressive lung damage.
• Help preserve lung function by slowing inflammation-mediated injury to the airways, which may contribute to improved long-term respiratory health.
• Support better disease management and quality of life by reducing recurrent infections and exacerbations that commonly affect patients with NCFB.

Brensocatib should be used under the supervision of a qualified healthcare professional as part of a comprehensive treatment plan for patients with non-cystic fibrosis bronchiectasis. It is intended to reduce disease progression and exacerbations and is not indicated for the treatment of acute respiratory infections or acute bronchiectasis exacerbations.

Brensocatib Tablets exert their therapeutic effect by selectively and reversibly inhibiting dipeptidyl peptidase-1 (DPP1), an enzyme responsible for activating neutrophil serine proteases (NSPs) during neutrophil maturation in the bone marrow. By inhibiting DPP1, Brensocatib reduces the activation of inflammatory enzymes such as neutrophil elastase, cathepsin G, and proteinase 3, which are known to contribute to chronic airway inflammation and lung tissue damage in patients with non-cystic fibrosis bronchiectasis (NCFB).

The reduction in NSP activity helps interrupt the cycle of persistent inflammation, recurrent respiratory infections, and progressive structural lung damage that characterizes NCFB. As a result, Brensocatib helps reduce the frequency of pulmonary exacerbations (flare-ups), limits ongoing airway injury, and supports better long-term disease control. Clinical studies have shown dose-dependent reductions in NSP activity, which correlate with improvements in disease outcomes.

By targeting the underlying inflammatory pathway rather than simply treating symptoms, Brensocatib offers a disease-modifying approach for patients with NCFB. Continued treatment may help preserve lung function, reduce airway inflammation, decrease disease progression, and improve patients' overall respiratory health and quality of life when used as part of a comprehensive management plan under the supervision of a healthcare professional.

Brensocatib Tablets should be taken exactly as prescribed by your healthcare provider. Do not change the dose, stop the treatment, or take the medicine for a longer period than recommended without consulting your physician. Brensocatib is intended for the long-term management of non-cystic fibrosis bronchiectasis (NCFB) and should be used under regular medical supervision.

• Take one tablet orally once daily, or as directed by your physician.
• Swallow the tablet whole with a glass of water. Do not crush, chew, or split the tablet unless specifically advised by your healthcare provider.
• Brensocatib Tablets may be taken with or without food.
• Take the medicine at the same time each day to help maintain consistent blood levels and improve treatment adherence.
• Continue taking Brensocatib regularly, even if you feel well, unless your healthcare provider advises you to stop treatment.
• If you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses on the same day or double the dose to make up for a missed dose. (accessdata.fda.gov)
• If you take more than the prescribed dose, contact your physician or seek immediate medical attention. In the event of a suspected overdose, patients should receive appropriate supportive and symptomatic treatment.

Important Instructions:

• Inform your healthcare provider about all prescription medicines, over-the-counter drugs, vitamins, and herbal supplements you are taking before starting Brensocatib.
• Tell your doctor if you have an active infection, recurrent infections, or are planning to receive a live attenuated vaccine, as additional precautions may be necessary during treatment.
• Attend all scheduled follow-up appointments so your healthcare provider can monitor your response to treatment and evaluate for any adverse effects.
• Do not share this medicine with anyone else, even if they have symptoms similar to yours.
• Brensocatib Tablets should only be used for the indication prescribed by a qualified healthcare professional and should not be used to treat acute respiratory infections or sudden bronchiectasis flare-ups. Continue any other prescribed therapies for bronchiectasis unless instructed otherwise by your physician.

Common:

• Headache
• Cough
• Nasopharyngitis (common cold symptoms)
• Upper respiratory tract infection
• Diarrhea
• Toothache
• Inflammation or bleeding of the gums (gingival disorders)
• Skin rash
• Dry skin
• Pruritus (itching)

Less Common:

• Mouth ulcers or irritation
• Periodontal (gum) disorders
• Mild gastrointestinal discomfort
• Nausea
• Fatigue
• Mild skin irritation or redness

Serious:

Although uncommon, patients should seek immediate medical attention if they experience:

• Signs of a severe allergic reaction, including swelling of the face, lips, tongue, or throat, difficulty breathing, or severe rash.
• Severe skin reactions, such as extensive rash, blistering, peeling, or painful skin lesions.
• Persistent or worsening infections, including fever, chills, persistent sore throat, or other signs of infection.
• Severe oral or gum problems, including significant gum swelling, bleeding, pain, or loosening of teeth.
• When to Contact Your Healthcare Provider

Contact your healthcare provider promptly if you:

• Develop any new or worsening skin changes.
• Experience persistent gum pain, swelling, bleeding, or dental problems.
• Notice symptoms suggestive of an infection.
• Experience any side effect that becomes severe or does not improve.

Regular medical and dental follow-up is recommended during treatment to monitor for adverse effects and to ensure the safe and effective use of Brensocatib. Patients should not discontinue treatment without consulting their healthcare provider unless advised to do so.

Brensocatib Tablets may interact with certain medications that affect its metabolism and absorption. Brensocatib is primarily metabolized by the CYP3A4 enzyme and is also a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters. Therefore, medicines that strongly inhibit or induce these pathways may alter brensocatib exposure. Patients should inform their healthcare provider about all prescription medicines, over-the-counter drugs, herbal products, and dietary supplements they are taking before starting treatment.

Brensocatib Tablets may interact with:

Strong CYP3A4 and P-gp inhibitors (e.g., clarithromycin) may increase brensocatib blood concentrations. Clinical studies showed increases in peak concentration (Cmax) and overall exposure (AUC); however, no dosage adjustment is currently recommended.

Moderate CYP3A4 and P-gp inhibitors (e.g., verapamil) may also increase brensocatib exposure, although the effect is not considered clinically significant, and dose adjustment is not generally required.

Strong CYP3A4 inducers (e.g., rifampin/rifampicin) may reduce brensocatib exposure by increasing its metabolism. Despite reduced drug exposure, routine dose adjustment is not recommended based on current prescribing information.

Acid-reducing agents, including proton pump inhibitors such as esomeprazole, do not have a clinically meaningful effect on the absorption or exposure of brensocatib and may be used concomitantly when clinically indicated.

CYP3A4 substrate medications (e.g., midazolam) are not expected to have clinically significant pharmacokinetic interactions when administered with brensocatib.

Although no routine dosage adjustments are recommended for the above interactions, healthcare professionals should continue to monitor patients receiving concomitant medications, particularly those taking drugs that strongly affect CYP3A4 or P-gp activity. Patients should avoid starting, stopping, or changing any medication without consulting their physician, as individual clinical circumstances may require additional monitoring.

• Store Brensocatib Tablets at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F to 86°F) in accordance with controlled room temperature guidelines.
• Keep the tablets in their original container until use to protect them from moisture.
• Keep the container tightly closed after each use.
• Store in a dry place, away from excessive heat, direct sunlight, and humidity.
• Do not store the medicine in bathrooms or other damp environments.
• Keep out of the reach and sight of children and pets.
• Do not use the tablets after the expiry date printed on the packaging.
• Dispose of any unused or expired medicine according to local pharmaceutical waste disposal regulations or as advised by a pharmacist. Do not dispose of medicines in household wastewater or household waste unless instructed to do so.

These storage recommendations help maintain the stability, safety, and effectiveness of Brensocatib Tablets throughout their shelf life.

Brensocatib is the first approved DPP1 inhibitor for non-cystic fibrosis bronchiectasis and is designed to target the underlying neutrophil-driven inflammation that contributes to disease progression. For optimal outcomes, it should be used consistently as part of a comprehensive bronchiectasis management plan that includes airway clearance, infection prevention, and regular follow-up with a respiratory specialist.

Children:

Use only as prescribed.

Brensocatib is approved for the treatment of non-cystic fibrosis bronchiectasis in adults and pediatric patients aged 12 years and older. The safety and effectiveness have not been established in children younger than 12 years of age; therefore, its use in this age group is not recommended unless future regulatory approvals expand the indication.

Elderly Patients:

Use with caution.

Clinical studies have not identified overall differences in the safety or effectiveness of Brensocatib between elderly and younger adult patients. No routine dose adjustment is required based on age alone. However, older adults are more likely to have concomitant medical conditions or receive multiple medications; therefore, regular clinical monitoring is advisable during treatment.

General Precautions:

• Take Brensocatib exactly as prescribed by your healthcare provider.
• Inform your physician if you have an active infection, recurrent infections, or are scheduled to receive a live attenuated vaccine, as additional precautions may be necessary.
• Maintain good oral hygiene and attend regular dental check-ups, as gingival and periodontal adverse reactions have been reported.
• Report any persistent skin rash, severe allergic reactions, signs of infection, or unusual oral symptoms immediately to your healthcare provider.
• Do not discontinue treatment without medical advice, even if symptoms improve.
• Inform your healthcare provider about all medicines, vitamins, herbal supplements, and over-the-counter products you are taking before starting Brensocatib.