regomaks Drug name: regomaks Generic name: Regorafenib Tablets/Regorafenib Export to China 3% customs VAT

The following is the information provided by Regorafenib :

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Drug Name

Generic Name : regorafenib
English name : Regorafenib
Product Name : regomaks

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Element

Main ingredient: Regorafenib Molecular formula: C21H15ClF4N4O3
Molecular weight: 482.8

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Pharmacological Action

Regorafenib is a multi-targeted tyrosine kinase inhibitor that blocks tumor angiogenesis, tumor growth, and tumor cell survival by inhibiting signaling pathways such as VEGFR, PDGFR, KIT, RAF, and FGFR.

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Indications

Regorafenib is indicated for the treatment of:

1. Metastatic colorectal cancer (mCRC) : patients who have failed chemotherapy or anti-VEGF or anti-EGFR therapy.
2. Gastrointestinal stromal tumors (GIST) : Patients who have failed previous treatment with imatinib and sunitinib.
3. Hepatocellular carcinoma (HCC) : Patients whose disease has progressed on sorafenib.

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Dosage

Recommended dose

• Starting dose: 160 mg (4 tablets of 40 mg) taken orally once a day for 21 days, and 7 days off for one cycle .
• Take with water, preferably with a low-fat meal.

Dosage Considerations

• The dose may be reduced to 120 mg or 80 mg depending on patient tolerance and adverse reactions.
• If serious adverse reactions occur, the medication can be temporarily interrupted or stopped if necessary.

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Adverse Reactions

Common adverse reactions (incidence ≥ 20%)

• Skin : hand-foot skin reaction, rash.
• Digestive system : diarrhea, nausea, decreased appetite, stomatitis.
• Body : Fatigue, weight loss.
• Metabolic : Hypertension, hyperbilirubinemia, hypophosphatemia.

Serious adverse reactions

• Hepatotoxicity: Severe liver damage may occur and liver function needs to be monitored.
• Bleeding: including severe gastrointestinal bleeding or intracranial hemorrhage.
• Cardiovascular events: May cause myocardial ischemia or myocardial infarction.
• Hypertensive crisis.
• Intestinal perforation or fistula formation.

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Precautions

1. Liver function monitoring : Liver function indicators such as ALT, AST and bilirubin should be monitored regularly before and during treatment.
2. Hypertension management : Blood pressure should be closely monitored during use and controlled with antihypertensive drugs if necessary.
3. Bleeding risk : Patients with bleeding risk should use with caution and avoid using anticoagulants during treatment.
4. Pregnancy and breast-feeding : May be harmful to the fetus, pregnant women are prohibited from using it; breast-feeding women should stop breastfeeding.
5. Elderly patients : Elderly patients may be more susceptible to drug-related adverse reactions and should be used with caution.

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Contraindications

• Allergic to regorafenib or its ingredients.
• Patients with severe hepatic impairment.

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Drug interactions

1. Strong CYP3A4 inhibitors (such as ketoconazole): may increase the blood concentration of regorafenib and should be used with caution.
2. Strong CYP3A4 inducers (such as rifampicin): May reduce drug efficacy and should be avoided in combination.
3. Anticoagulants (eg, warfarin): May increase risk of bleeding and require close monitoring.

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Storage

• Storage Conditions : Store at room temperature (15-30°C), away from moisture and direct sunlight.
• Expiration date : Please refer to the drug packaging label.

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Production information

• Manufacturer : Laos State-owned Second Pharmaceutical Factory.
• Approval number : as approved by the State Food and Drug Administration.

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Medication Instructions

Before using regorafenib, it is recommended to consult a doctor or pharmacist in detail and strictly follow the doctor's instructions. If serious adverse reactions occur, stop taking the medicine immediately and seek medical help.