Generic
Sorafenib
9 brands available in the market
At a glance
Sorafenib is a tyrosine kinase inhibitor used for the treatment of unresectable hepatocellular carcinoma, advanced renal cell carcinoma, and thyroid cancer. It inhibits tumor cell proliferation and angiogenesis.
Description
Sorafenib is a kinase inhibitor that inhibits multiple intracellular kinases (CRAF, BRAF, mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-β). These kinases are involved in tumor cell signaling, angiogenesis, and apoptosis. Sorafenib inhibits tumor growth and angiogenesis.
Indications
- Unresectable hepatocellular carcinoma (HCC)
- Advanced renal cell carcinoma (RCC)
- Thyroid cancer
Therapeutic class
Targeted Cancer Therapy
Pharmacological class
Tyrosine Kinase Inhibitor (TKI)
Pharmacology
Sorafenib inhibits multiple intracellular kinases (CRAF, BRAF, mutant BRAF) and cell surface kinases (VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-β, KIT, FLT-3, RET). It blocks RAF/MEK/ERK signaling and VEGF-mediated angiogenesis, reducing tumor cell proliferation and tumor angiogenesis.
Mechanism of action
Inhibits tumor cell proliferation and angiogenesis.
Dosage
Adult Dose (Oral):
- Recommended: 400 mg twice daily (without food, 1 hour before or 2 hours after a meal)
- Continue until clinical benefit or unacceptable toxicity
- Dose reduction: 400 mg once daily; if needed, 400 mg every other day
Administration
- Take on an empty stomach (1 hour before or 2 hours after meals)
- Swallow tablet whole; do not chew, crush, or break
- Take at the same time each day
Missed dose
If you miss a dose, skip it and continue with your normal schedule; do not double the dose.
Side effects
Common Side Effects:
- Fatigue
- Nausea, loss of appetite
- Diarrhea, abdominal pain
- Hair loss, weight loss
- Rash, painful blisters on hands and feet (hand-foot skin reaction)
Serious:
- Cardiac ischemia/infarction
- Hemorrhage, hypertension
- Gastrointestinal perforation
Precautions & warnings
- Cardiac ischemia/infarction: Consider temporary or permanent discontinuation
- Hemorrhage: Consider permanent discontinuation if medical intervention needed
- Hypertension: Regular monitoring; temporary/permanent discontinuation for severe or persistent
- GI perforation: Discontinue
- With warfarin: Monitor INR/prothrombin time
Contraindications
- Severe hypersensitivity to sorafenib or any component
- Combination with carboplatin/paclitaxel in squamous cell lung cancer
Drug interactions
- Carboplatin/paclitaxel: Increased mortality in squamous cell lung cancer (contraindicated)
- UGT1A1/UGT1A9 substrates: Increased exposure
- Docetaxel: 36-80% increase in AUC (caution)
- Doxorubicin: 21% increase in AUC (caution)
- Rifampicin: 37% decrease in AUC
- Neomycin: 54% decrease in AUC
Food interactions
It is not known whether alcohol is safe with Sorafenib; consult your doctor.
Use in pregnancy
Use in Pregnancy: Unsafe (Category D); evidence of fetal risk; use only in life-threatening situations; consult your doctor.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Unsafe; may cause toxicity to the baby; do not use; consult your doctor.
Pediatric use
Safety and efficacy not established in pediatric patients
Geriatric use
No differences in safety or efficacy between older and younger patients
Renal / hepatic impairment
Renal Impairment: Safe in kidney disease; no dose adjustment needed; consult your doctor.
Hepatic Impairment: Mild-moderate (Child-Pugh A/B): no dose adjustment; severe (Child-Pugh C): not studied; consult your doctor.
Overdose effects
No specific antidote; highest clinical dose 800 mg twice daily; diarrhea and dermatologic reactions are primary; provide symptomatic treatment.
Storage conditions
Store at room temperature below 30°C; do not remove desiccant; dispense in original bottle.
Chemical structure
Sorafenib