LuciBren25mg

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciBren safely and effectively. See full prescribing information for LuciBren.

INDICATIONS AND USAGE

LuciBren 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.

DOSAGE AND ADMINISTRATION

Recommended dosage: 10 mg or 25 mg orally once daily with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 25 mg×30 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Dermatologic Adverse Reactions: Monitor for new rash or skin conditions and refer to dermatology for evaluation.

Gingival and Periodontal Adverse Reactions: Gingival and periodontal adverse reactions can occur with LuciBren use. Refer to the dental care services for regular dental checkups and advise patients to perform routine dental hygiene.

Live Attenuated Vaccines: It is unknown whether administration of live attenuated vaccines during LuciBren treatment will affect the safety or effectiveness of the vaccines. Avoid use of live attenuated vaccines.

ADVERSE REACTIONS

Most common adverse reactions (incidence >2%): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.