Regorafenib: Uses, Dosage, Side Effects & Brands | MedexInfo

Regorafenib

Rx Only

Generic NameRegorafenib

Therapeutic ClassMultikinase Inhibitor

Common Dose160 mg orally once daily, 3 weeks on / 1 week off

Max / 24h160 mg

PregnancyCategory D

Indications ▼

Metastatic colorectal cancer previously treated with standard therapy

Unresectable or metastatic gastrointestinal stromal tumors (GIST)

Hepatocellular carcinoma in patients who have been previously treated with sorafenib

Mechanism & Pharmacokinetics ▼

Mechanism: Oral multikinase inhibitor targeting VEGFR, PDGFR, FGFR, KIT, RET, RAF, and other kinases to inhibit tumor angiogenesis, proliferation, and survival.

Pharmacokinetics: Rapid oral absorption; extensively metabolized in liver (CYP3A4, UGT1A9); peak plasma ~4 hours; half-life ~28 hours; excreted mainly in feces.

Dosage & Administration ▼

Patient Category	Recommended Dose	Max / 24h
Adults (mCRC / GIST / HCC)	160 mg orally once daily for 21 days, followed by 7 days off (28-day cycle)	160 mg
Elderly	Start at 80–160 mg; monitor tolerance and adjust dose	160 mg
Hepatic Impairment	Moderate: consider 80 mg; Severe: avoid	160 mg
Renal Impairment	Mild to moderate: standard dose; severe: monitor closely	160 mg

Note: Take with water at the same time each day, with or without food. Monitor blood pressure, liver function, and hand-foot skin reactions.

Side Effects ▼

Common: Fatigue, diarrhea, hand-foot skin reaction, hypertension

Occasional: Rash, anorexia, nausea, abdominal pain

Rare: Hepatotoxicity, cardiac ischemia, bleeding, severe hypersensitivity

Contraindications ▼

Hypersensitivity to Regorafenib or excipients

Severe hepatic impairment (Child-Pugh C)

Pregnancy (Category D) and breastfeeding

Drug Interaction ▼

CYP3A4 inhibitors (e.g., ketoconazole) increase plasma levels

CYP3A4 inducers (e.g., rifampin) decrease plasma levels

Concomitant anticoagulants increase bleeding risk

Pregnancy & Lactation ▼

Pregnancy Category D; contraindicated

Not recommended during breastfeeding

Clinical / Research Summary ▼

Shown to improve overall survival in refractory mCRC and GIST patients

Reduces tumor angiogenesis and proliferation via multikinase inhibition

Used in clinical trials for HCC with manageable safety profile

Patient Counseling Points ▼

Take exactly as prescribed; do not skip doses

Report hand-foot skin reaction, bleeding, or hypertension

Regularly monitor liver function, blood pressure, and cardiac status

Storage & Handling ▼

Store at 20–25°C; protect from moisture and light

Keep out of reach of children

Brand Names (Bangladesh & Global) ▼

Bangladesh:

Regonix® 40 mg Reganex® 40 mg Regocent® 40 mg Regora® 40 mg Regotab® 40 mg Renib® 40 mg

Global:

Stivarga® Regorafenib (Generic)

Medical Disclaimer: This information is for educational purposes only. Consult a qualified healthcare professional for diagnosis and treatment.

Reference Hubs:

• Drug Class: Multikinase Inhibitors • Condition: Metastatic Colorectal Cancer • Condition: Gastrointestinal Stromal Tumor (GIST) • Clinical Evidence & Trials