Lucius Version of Regorafenib: Dosage and Administration, Indications, Precautions

Lucius Version of Regorafenib: Dosage and Administration, Indications, Precautions

Indications

Regorafenib is a kinase inhibitor 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.

Dosage and Administration

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

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

Use in Specific Populations

Lactation: Decide whether to discontinue the drug or discontinue breastfeeding after comprehensively weighing the benefits and risks of the drug to the mother and the breastfeeding infant.

Warnings and Precautions

Bleeding: Permanent discontinuation of Regorafenib is required for severe or life-threatening bleeding.

Skin Toxicity: Interrupt, reduce the dose, or discontinue Regorafenib based on the severity and duration of skin toxicity.

Hypertension: Temporarily or permanently discontinue Regorafenib for severe or uncontrolled hypertension.

Cardiac Ischemia and Infarction: Suspend Regorafenib for new or acute cardiac ischemia/infarction; resumption of use is only allowed after the resolution of the acute ischemic event.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue Regorafenib.

Gastrointestinal Perforation or Fistula: Discontinue Regorafenib.

Wound Healing Complications: Discontinue Regorafenib prior to surgery. Patients with wound dehiscence should discontinue the drug.

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

Drug Interactions

Strong CYP3A4 Inducers: Avoid the use of strong CYP3A4 inducers.

Strong CYP3A4 Inhibitors: Avoid the use of strong CYP3A4 inhibitors.

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.

Contraindications

Not yet established.

Dosage Form

Tablets.

Storage Method

Store at 20°C to 25°C (68°F to 77°F); short-term transportation is permitted at temperatures ranging from 15°C to 30°C (59°F to 86°F).