HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciLusu is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

DOSAGE AND ADMINISTRATION

• Begin LuciLusu dosing 8-14 days prior to a scheduled procedure.

• Patients should undergo their procedure 2-8 days after the last dose.

• Recommended Dosage: 3 mg orally once daily with or without food for 7 days .

DOSAGE FORMS AND STRENGTHS

Tablets: 3 mg×7 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Thrombotic/Thromboembolic Complications: LuciLusu is a thrombopoietin (TPO) receptor agonist, and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Monitor platelet counts and for thromboembolic events and institute treatment promptly.

ADVERSE REACTIONS

The most common adverse reaction (>3%): headache.

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding is not recommended during treatment.

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.