HIGHLIGHTS OF PRESCRIBING INFORMATION 

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

INDICATIONS AND USAGE

LuciRegor is a kinase inhibitor indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an antiVEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. 

DOSAGE AND ADMINISTRATION 

• Recommended Dose: 160 mg orally, once daily for the first 21 days of each 28-day cycle. 

• Take LuciRegor with food (a low-fat breakfast). 

DOSAGE FORMS AND STRENGTHS 

Tablets: 40 mg×28 tablets

CONTRAINDICATIONS 

None.

WARNINGS AND PRECAUTIONS 

• Hemorrhage: Permanently discontinue LuciRegor for severe or life-threatening hemorrhage.

• Dermatological toxicity: Interrupt and then reduce or discontinue LuciRegor depending on severity and persistence of dermatologic toxicity.

• Hypertension: Temporarily or permanently discontinue LuciRegor for severe or uncontrolled hypertension.

• Cardiac ischemia and infarction: Withhold LuciRegor for new or acute cardiac ischemia/infarction and resume only after resolution of acute ischemic events. 

• Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue LuciRegor.

• Gastrointestinal perforation or fistulae: Discontinue LuciRegor. 

• Wound healing complications: Stop LuciRegor before surgery. Discontinue in patients with wound dehiscence. 

• Embryofetal toxicity: Can cause fetal harm. Advise women of potential risk to a fetus. 

ADVERSE REACTIONS 

The most common adverse reactions (≥30%) are asthenia/fatigue, decreased appetite and food intake, hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia (PPE)], diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia. 

DRUG INTERACTIONS 

• Strong CYP3A4 inducers: Avoid strong CYP3A4 inducers. 

• Strong CYP3A4 inhibitors: Avoid strong CYP3A4 inhibitors. 

USE IN SPECIFIC POPULATIONS 

Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of the drug to the mother. 

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.