HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciVeric is a soluble guanylate cyclase (sGC) stimulator, indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

DOSAGE AND ADMINISTRATION

· The recommended starting dose of LuciVeric is 2.5 mg orally once daily with food.

· Double the dose of LuciVeric approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient.

· Tablets may be crushed and mixed with water for patients who have difficulty swallowing.

DOSAGE FORMS AND STRENGTHS

Tablets: 10 mg×98 tablets

CONTRAINDICATIONS

• Patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.

• Pregnancy

WARNINGS AND PRECAUTIONS

Based on data from animal reproduction studies, LuciVeric may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with LuciVeric and for at least one month after the final dose.

ADVERSE REACTIONS

Most common adverse reactions reported in ≥5% are hypotension and anemia.

DRUG INTERACTIONS

• PDE-5 Inhibitors: Concomitant use is not recommended.

USE IN SPECIFIC POPULATIONS

• Lactation: Breastfeeding is not recommended.

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.