Brensocatib

Brensocatib is used in adults and children at least 12 years old to treat non-cystic fibrosis bronchiectasis.

Brensocatib may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Brensocatib is usually taken once per day. Follow your doctor's instructions.

You may take brensocatib with or without food, but take it the same way each time.

While taking brensocatib, check your skin and keep regular dental checkups. Call your doctor or dentist if you notice a new rash or any gum or tooth pain, swelling, or bleeding.

Store this medicine in the original container at room temperature away from moisture and heat.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• skin problems, or any new rash;
• mouth or dental problems; or
• if recently received or are scheduled to receive a vaccine.

Make sure you are current on all vaccines before you start using brensocatib.

It is not known if brensocatib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using brensocatib.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Brensocatib may cause serious side effects. Call your doctor at once if you have:

• new or worsening skin rash or skin condition; or
• mouth sores, red or swollen gums, or new dental symptoms.

Common side effects of brensocatib may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• headache;
• abnormal blood tests;
• skin cancers;
• high blood pressure;
• skin rash, dry skin, hair loss (alopecia); or
• hardening of your skin (hyperkeratosis).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Bronchiectasis:

10 or 25 mg orally once a dayUse: For the treatment of non-cystic fibrosis bronchiectasis (NCFB)

Usual Pediatric Dose for Bronchiectasis:

12 years and older: 10 or 25 mg orally once a dayUse: For the treatment of NCFB

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid receiving a "live" vaccine while you are being treated with brensocatib.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect brensocatib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.