Brensocatib

Brensocatib is a prescription medicine indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years of age and older 

• Brensocatib is available under the following different brand names: Brinsupri

Common side effects of Brensocatib include:

• upper respiratory tract infection 
• dry skin 
• rash
• hyperkeratosis
• headache 
• hypertension

Serious side effects of Brensocatib include:

• new or worsening skin symptoms
• new gingival or dental symptoms

Rare side effects of Brensocatib include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adults and pediatric dosage

Oral tablet

• 10 mg
• 25 mg

Bronchiectasis

Adult and pediatric dosage

• 10 mg or 25 mg orally daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

Drug interaction overview

• Live attenuated vaccines
  • Avoid
  • Concomitant use with live attenuated vaccines has not been evaluated

Unknown whether administration of live attenuated vaccines during brensocatib treatment will affect vaccine safety or efficacy

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Brensocatib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Brensocatib?”

Cautions

• Dermatologic reactions
  • Treatment associated with increased incidence of dermatologic adverse reactions (eg, rash, dry skin, hyperkeratosis)
  • Monitor for the development of new rashes or skin conditions
  • Refer patients to a dermatologist for evaluation of new dermatologic findings
• Gingival and periodontal reactions
  • Treatment associated with an increased incidence of gingival and periodontal adverse reactions
  • Refer patients to dental care services for regular dental checkups during therapy
  • Advise patients to perform routine dental hygiene

Pregnancy and Lactation

Pregnancy

• Data are unavailable regarding use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Lactation

• Data are unavailable regarding the presence of brensocatib and/or its metabolite(s) in human milk, its effects on breastfed infants, or milk production
• Consider the developmental and health benefits of breastfeeding along with the clinical need of the mother and any potential adverse effects on breastfed children from brensocatib underlying maternal condition