HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciAtras is an endothelin receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.

This indication is approved under accelerated approval based on a reduction of proteinuria. It has not been established whether LuciAtras slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

DOSAGE AND ADMINISTRATION

• 0.75 mg orally once daily with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 0.75 mg×30 tablets

CONTRAINDICATIONS

• Pregnancy.

• Hypersensitivity.

WARNINGS AND PRECAUTIONS

• Hepatotoxicity.

• Fluid Retention.

• Decreased Sperm Counts.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 5%) were peripheral edema and anemia.

DRUG INTERACTIONS

• Strong or moderate CYP3A inducers: Avoid concomitant use.

• OATP1B1/1B3 inhibitors: Avoid concomitant use.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed.

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.