Stivarga (Regorafenib) – Colorectal cancer | HongKong DengYue Medicine

Regorafenib Application Scope

Regorafenib is a multi-kinase inhibitor that targets several pathways involved in tumor growth and cancer spread. It’s primarily used for the treatment of:

• Colorectal Cancer (metastatic)

• Gastrointestinal Stromal Tumors (GIST) (after failure of prior treatment)

• Hepatocellular Carcinoma (HCC)

• Renal Cell Carcinoma (RCC)

Regorafenib Characteristics

• Ingredients: The active ingredient is Regorafenib.

• Properties:​ Regorafenib acts by inhibiting several kinases involved in tumor growth, angiogenesis, and metastasis. These include VEGFR, PDGFR, KIT, and RET, among others.

• Packaging Specification:​ Typically available in tablet form, with a strength of 40 mg per tablet.

• Storage:​ Store at room temperature, away from moisture and heat.

• Expiry Date: Refer to the packaging for the expiry date. Generally, it is 2-3 years from the manufacturing date.

• Executive Standard: ​Based on local health regulatory standards, such as the US FDA or EMA for Europe.

• Approval Number: The specific approval number can be found on the drug’s packaging, subject to local regulatory bodies.

• Date of Revision: As indicated by the latest update from the manufacturer or regulatory authorities.

• Manufacturer:  Stivarga

Guidelines for the Use of Regorafenib

• Dosage and Administration:

  • Recommended Dose: Typically, 160 mg/day, taken orally once daily for 21 days of a 28-day cycle. However, dose adjustments are common based on tolerability and side effects.

  • Administration: Taken with a low-fat meal to reduce gastrointestinal side effects. Swallow tablets whole without crushing or chewing.

  • Missed Dose:​ If a dose is missed, skip it and take the next dose at the usual time. Do not double the dose to make up for a missed dose.

• Adverse Reactions:

  • Common Adverse Reactions:

    • Fatigue

    • Diarrhea

    • Hypertension

    • Rash

    • Hand-foot skin reactions (palmar-plantar erythrodysesthesia)

  • Serious Adverse Reactions:

    • Severe liver toxicity (hepatotoxicity)

    • Gastrointestinal perforation

    • Hemorrhage

    • Reversible posterior leukoencephalopathy syndrome (RPLS)

    • Myocardial infarction (heart attack)

    • Severe bleeding (including nosebleeds)

• Contraindications:

  • Known hypersensitivity to Regorafenib or any of its components.

  • Severe liver impairment (Child-Pugh Class C).

  • Pregnancy (Category D – avoid use during pregnancy).

• Precautions:

  • Monitor liver function before and during treatment.

  • Hypertension: Control prior to starting treatment and monitor regularly.

  • Hemorrhagic Events: Regular monitoring for signs of bleeding.

  • Use with caution in patients with cardiac or vascular diseases.

Regorafenib Interactions

• CYP3A4 Inhibitors/Inducers: May affect Regorafenib levels. Drugs that inhibit or induce CYP3A4 can alter the effectiveness of Regorafenib.

• Warfarin and other anticoagulants: Increased risk of bleeding.

• Antihypertensive drugs: Potentiation of anti-hypertensive effects, increasing the risk of hypotension.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.