Sorafenib

What it is and how it works

Mechanism of Action Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (c-CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT- 3, RET, RET/PTC, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis and apoptosis. Sorafenib inhibited tumor growth of HCC, RCC, and DTC human tumor xenografts in immunocompromised mice. Reductions in tumor angiogenesis were seen in models of HCC and RCC upon sorafenib treatment, and increases in tumor apoptosis were observed in models of HCC, RCC, and DTC.

Mechanism class: Protein Kinase Inhibitors

Indications

Sorafenib tablets are a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma • Advanced renal cell carcinoma • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). Renal Cell Carcinoma Sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (RCC). Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.

Dosage and administration (summary)

The recommended dosage is 400 mg orally twice daily without food. Recommended Dosage The recommended dosage of sorafenib tablets are 400 mg orally twice daily without food (at least 1 hour before or 2 hours after a meal) until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity. Dosage Modifications for Adverse Reactions Recommended Dosage Modifications The recommended dosage modifications for adverse reactions are provided in Tables 1, 2, and 3.

Contraindications

•Sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. •Sorafenib tablets in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer . •Sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets.

Warnings and precautions

• Cardiovascular Events : Consider temporary or permanent discontinuation of sorafenib tablets. ( 2.2 , 5.1 ) • Hemorrhage: Discontinue sorafenib tablets if needed. • Hypertension: Monitor blood pressure weekly during the first 6 weeks and periodically thereafter. Consider temporary or permanent discontinuation for severe or persistent hypertension despite antihypertensive therapy. • Dermatologic Toxicities : Interrupt and/or decrease dose. Discontinue for severe or persistent reactions, or if Stevens-Johnson syndrome and toxic epidermal necrolysis is suspected.

Pregnancy

Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action , sorafenib may cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk.

Storage and supply

Sorafenib Tablets are supplied as 200 mg, round biconvex, red film-coated tablets, debossed with "F11" on one side and plain on the other side. Bottles of 30 NDC 13668-682-30 Bottles of 60 NDC 13668-682-60 Bottles of 120 NDC 13668-682-12 100 (10×10) unit-dose tablets NDC 13668-682-74 Store at 20° to 25°C (68° to 77°F).

Source: Sorafenib (Sorafenib) — US FDA prescribing information, 2026-02-11, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.