Formulation and specifications: Tablets: 40mg
Indications:
1. Patients with hepatocellular carcinoma who have received prior treatment with sorafenib.
2. Patients with locally advanced, inoperable or metastatic gastrointestinal mesenchymal tumors previously treated with imatinib and sunitinib.
3. Patients with metastatic colorectal cancer who have received prior fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, and who have received prior or are not candidates for anti-VEGF therapy, or anti-EGFR therapy (RAS wild type).
Key points for rational drug use:
1. Genetic testing is not required prior to drug administration.
2. The drug insert recommends a dose of 160 mg orally once daily with food and 1 week off for 3 weeks. Based on individual safety and tolerability considerations, it may be necessary to interrupt or reduce the dose, and a gradual increase in the starting dose of 80-120mg may be considered. The tablet must be swallowed whole and should not be replaced within the same day if missed or vomited.
The most common adverse reactions in the Asian population are skin reactions in the hands and feet, abnormal liver function (hyperbilirubinemia, elevated ALT, elevated AST) and hypertension, as well as pain, malaise, diarrhea, decreased appetite and decreased eating; the most serious adverse reactions are severe hepatic impairment, bleeding, gastrointestinal perforation and infection; caution should be used in patients with a history of thrombosis or embolism.
4. Contraindicated in patients with hypersensitivity reactions to any of the active substances or excipients of Regorafenib.
5. Avoid co-administration of potent inhibitors and inducers of CYP3A4. Co-administration of irinotecan may increase systemic exposure to UGT1A1 and UGT1A9 substrates.