lucius luciregor regorafenib tablets 40mg

Indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and—if KRAS wild-type—anti-EGFR therapy.

Description

Indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and—if KRAS wild-type—anti-EGFR therapy.

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Product Description

Product Name: LuciRegor

Chinese Name: Regorafenib Tablets

English Name: Regorafenib Tablets


【Indications】

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


【Dosage and Administration】

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

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


【Strength】 40 mg/tablet, 28 tablets/box.


【Contraindications】 None.


【Warnings and Precautions】

Hemorrhage: Permanently discontinue LuciRegor in cases of severe or life-threatening hemorrhage.

Dermatologic toxicity: Interrupt, reduce the dose, or discontinue LuciRegor based on the severity and duration 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; resume only after the acute ischemic event has resolved.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue LuciRegor.

Gastrointestinal perforation or fistula: Discontinue LuciRegor.

Wound healing complications: Stop LuciRegor prior to surgery. Discontinue in patients with wound dehiscence.

Embryo-fetal toxicity: May cause fetal harm. Advise females of the potential risk to the 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]

Potent CYP3A4 inducers: Avoid the use of potent CYP3A4 inducers.


[Use in Specific Populations]

Lactation: Weigh the benefits and risks of the drug to the mother and the nursing infant to decide whether to discontinue the drug or discontinue breastfeeding.


[Storage]

Store at 20°C to 25°C (68°F to 77°F); brief excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.


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