HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciDap is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months.

Limitations of Use

Not shown to improve quality of life, fatigue, or patient well-being.

Not indicated for use:

• As a substitute for transfusion in patients requiring immediate correction of anemia.

• In patients not on dialysis.

DOSAGE AND ADMINISTRATION

• Administer orally once daily, with or without food.

• See Full Prescribing Information for starting dosage based on hemoglobin level, liver function and concomitant medications, and for dose titration and monitoring recommendations.

DOSAGE FORMS AND STRENGTHS

Tablets: 1 mg×100 tablets

CONTRAINDICATIONS

• Strong cytochrome P450 2C8 (CYP2C8) inhibitors such as gemfibrozil.

• Uncontrolled hypertension.

WARNINGS AND PRECAUTIONS

• Risk of Hospitalization for Heart Failure: Increased in patients with a history of heart failure.

• Hypertension: Worsening hypertension, including hypertensive crisis may occur. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.

• Gastrointestinal Erosion: Gastric or esophageal erosions and gastrointestinal bleeding have been reported.

• Not indicated for treatment of anemia of CKD in patients who are not dialysis-dependent.

• Malignancy: May have unfavorable effects on cancer growth. Not recommended if active malignancy.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥10%) are hypertension, thrombotic vascular events, and abdominal pain.

DRUG INTERACTIONS

• Moderate CYP2C8 Inhibitors: Reduce starting dose.

• CYP2C8 Inducers: Monitor hemoglobin and adjust the dose of LuciDap as appropriate.

USE IN SPECIFIC POPULATIONS

• Pregnancy: May cause fetal harm.

• Lactation: Breastfeeding not recommended until one week after the final dose.

• Hepatic Impairment: Reduce the starting dose in patients with moderate hepatic impairment (Child-Pugh Class B). LuciDap not recommended in severe hepatic impairment (Child-Pugh Class C).

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.