LuciRegor Regorafenib 40mg 28 tablets exported to China 3% customs VAT

LuciRegor simple instructions

Please use under the guidance of a physician

Product Name: LuciRegor

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Regorafenib tablets

English name: Regorafenib tablets

Drug approval number: 08 L 1168/24

【Indications】

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

【Usage and Dosage】

•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).

【Specification】

40mg/tablet, 28 tablets/box.

【Contraindications】

none.

【Warnings and precautions】

• Bleeding: Severe or life-threatening bleeding should result in permanent discontinuation of LuciRegor.

• Skin Toxicity: Depending on the severity and duration of skin toxicity, decide to interrupt, reduce, or discontinue LuciRegor.

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

• Cardiac Ischemia and Infarction: For new or acute cardiac ischemia/infarction, withhold LuciRegor and resume only after resolution of the acute ischemic event.

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

•Gastrointestinal perforation or fistula: Discontinue LuciRegor.

•Wound healing complications: Discontinue use of LuciRegor prior to surgery. Discontinue use in patients with wound dehiscence.

• Embryo-Fetal Toxicity: May cause harm to the fetus. Inform females of the potential risk to a fetus.

【Adverse Reactions】

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

【Drug Interactions】

•Strong CYP3A4 inducers: Avoid use with strong CYP3A4 inducers.

•Strong CYP3A4 inhibitors: Avoid use with strong CYP3A quad inhibitors.

【Use by specific groups】

Lactation: Comprehensively consider the pros and cons of the drug to the mother and breastfeeding, and decide whether to stop taking the drug or stop breastfeeding.

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.