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Regorafenib ALIREGFENIB 40mg
1. For the treatment of patients with metastatic colorectal cancer (mCRC) who have previously received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, as well as prior or inappropriate anti-VEGF, anti-EGFR (Ras wild-type) therapy. 2. Patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumors (gist) previously treated with imatinib mesylate and sunitinib malate. 3. Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
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- Contraindications
- 【Precautions】
Liver function tests (ALT, AST and bilirubin) are recommended before starting treatment and are closely monitored (at least once every two weeks) for 2 months from the start of treatment. Thereafter, it should be monitored at least monthly on a regular basis or as clinically indicated.
Since regorafenib has not been studied in patients with hepatic function Child-Pugh C and exposure may be increased in such patients, regorafenib is not recommended for this population.
In case of worsening of infection, discontinuation of regorafenib treatment should be considered.
Before starting treatment, esophageal varices screening and subsequent treatment in patients with cirrhosis should be performed according to standard therapeutic practice. In case of severe bleeding requiring urgent medical intervention, permanent discontinuation of regorafenib should be considered.
Discontinuation is recommended for patients with gastrointestinal perforation or fistula.
Patients with a history of ischemic heart disease should be monitored for clinical signs and symptoms of myocardial ischemia. For patients with myocardial ischemia and/or infarction, interruption is recommended until recovery. The decision to restart regorafenib can be made after careful consideration of the potential benefits and risks for individual patients. If not restored, it should be permanently deactivated.
Blood Pressure: For severe or uncontrolled Blood Pressure, temporarily or permanently discontinue regorafenib.
Women of childbearing age must be informed that regorafenib may harm the fetus, and women and men of childbearing age should ensure effective contraception during treatment and up to 8 weeks after treatment.
It should not be used during pregnancy, if necessary, and only after careful consideration of the benefits to the mother and the risks to the fetus.
Breastfeeding must be discontinued during treatment. - Medication risks
- [Adverse reactions] The most common adverse reactions are: pain, hand-foot skin reaction, weakness/fatigue, diarrhea, decreased appetite and eating, blood pressure, and infection.
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