HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciApro is an endothelin receptor antagonist indicated for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.

DOSAGE AND ADMINISTRATION

• The recommended dosage of LuciApro is 12.5 mg orally once daily, with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 12.5 mg×30 tablets

CONTRAINDICATIONS

• Pregnancy.

• Hypersensitivity.

WARNINGS AND PRECAUTIONS

• ERAs cause hepatotoxicity and liver failure. Measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and repeat periodically during treatment and as clinically

indicated.

• Fluid retention may require intervention.

• Decreases in hemoglobin.

• Decreased sperm counts.

ADVERSE REACTIONS

Most common adverse reactions (more frequent than placebo and ≥ 2% in LuciApro-treated patients) are edema/fluid retention and anemia.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed.

Storage

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