LUCIFINE

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.