LuciRegor

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.