HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LUCIFINE is a non-steroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

DOSAGE AND ADMINISTRATION

• The recommended starting dosage is 10 mg or 20 mg orally once daily based on estimated glomerular filtration rate (eGFR) and serum potassium thresholds.

• Increase dosage after 4 weeks to the target dose of 20 mg once daily, based on eGFR and serum potassium thresholds.

• Tablets may be taken with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 10 mg×30 tablets

CONTRAINDICATIONS

• Concomitant use with strong CYP3A4 inhibitors.

• Patients with adrenal insufficiency.

WARNINGS AND PRECAUTIONS

• Hyperkalemia. Patients with decreased kidney function and higher baseline potassium levels are at increased risk.  Monitor serum potassium levels and adjust dose as needed.

ADVERSE REACTIONS

Adverse reactions occurring in ≥ 1% of patients on LUCIFINE and more frequently than placebo are hyperkalemia, hypotension, and hyponatremia.

DRUG INTERACTIONS

• Strong CYP3A4 Inhibitors: Use is contraindicated.

• Grapefruit or grapefruit juice: Avoid concomitant use.

• Moderate or weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either LUCIFINE or the moderate or weak CYP3A4 inhibitor, and adjust LUCIFINE dosage as appropriate.

• Strong or moderate CYP3A4 Inducers: Avoid concomitant use.

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding not recommended.

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.