Sorafenib is an oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases involved in tumor cell proliferation and angiogenesis. It is a cornerstone targeted therapy for advanced hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC) in the Indian context, where these cancers have a high disease burden. It is also used in radioactive iodine-refractory differentiated thyroid carcinoma (DTC).
Adult: 400 mg (two 200 mg tablets) orally twice daily (approximately 12 hours apart), without food (at least 1 hour before or 2 hours after a meal).
Note: Swallow tablet whole with a glass of water. Do not crush or chew. Administer on an empty stomach (1 hour before or 2 hours after eating). If a dose is missed, do not take an extra dose; take the next dose at the regular scheduled time.
Sorafenib is a small molecule inhibitor that targets multiple intracellular (CRAF, BRAF, mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-β). By inhibiting these kinases, it exerts a dual anti-tumor effect: 1) Inhibition of tumor cell proliferation (via RAF/MEK/ERK pathway) and 2) Inhibition of tumor angiogenesis (via VEGFR and PDGFR pathways).
Pregnancy: Category D. May cause fetal harm based on mechanism. Women of childbearing potential must use effective contraception during and for at least 2 weeks after therapy. Men with female partners of childbearing potential should use condoms.
Driving: Patients should be cautioned about potential fatigue and dizziness which may impair the ability to drive or operate machinery.
| Warfarin | Increased risk of bleeding; monitor INR closely. | Major |
| Rifampicin (Strong CYP3A4 Inducer) | Significantly decreases sorafenib plasma concentration; avoid concomitant use. | Major |
| Ketoconazole (Strong CYP3A4 Inhibitor) | May increase sorafenib plasma concentration; monitor for toxicity. | Moderate |
| Doxorubicin | Increased plasma concentration of doxorubicin; increased risk of cardiotoxicity. | Moderate |
| Neomycin (Oral) | May decrease sorafenib bioavailability by altering gut flora. | Moderate |
| Drugs metabolized by UGT1A1 (e.g., Irinotecan) | Sorafenib inhibits UGT1A1, potentially increasing toxicity of these drugs. | Moderate |
| QT Prolonging Drugs (e.g., Amiodarone, Ciprofloxacin) | Additive risk of QTc prolongation; monitor ECG. | Moderate |