- Indications and Usage Sorafenib is indicated for the treatment of unresectable hepatocellular carcinoma (HCC), advanced renal cell carcinoma (RCC), and progressive, locally advanced, or metastatic differentiated thyroid cancer (DTC).
- Dosage and Administration Recommended Dosage: The recommended dose is 400 mg (2 × 200 mg tablets) taken orally twice daily. Administration: Take on an empty stomach or with low-fat or medium-fat meals. Swallow whole with water. Dose Modifications: For toxicity management, interrupt and then resume at a reduced dose of 400 mg once daily or every other day. For skin toxicity, interrupt until resolved to Grade 0-1 before resuming at the reduced dose. Special Populations: No dose adjustment is required for mild to moderate hepatic impairment (Child-Pugh A or B) or mild to moderate renal impairment.
- Mechanism of Action Sorafenib is an oral multi-kinase inhibitor. It blocks intracellular Ras/Raf/MEK/ERK signaling pathways by inhibiting Raf-1 and mutant B-Raf, thereby inhibiting cell proliferation and inducing apoptosis. It also blocks extracellular signaling by inhibiting vascular endothelial growth factor receptors (VEGFR)-2 and -3, and platelet-derived growth factor receptor-beta (PDGFR-beta), thereby inhibiting tumor angiogenesis.
- Safety and Warnings Hemorrhage: Serious or fatal bleeding events have occurred. Permanently discontinue for severe or uncontrollable bleeding. Cardiac Damage: Monitor for signs and symptoms of ischemia or myocardial infarction. Discontinue if cardiac damage occurs. Hypertension: Monitor blood pressure regularly. Permanently discontinue for severe or resistant hypertension or hypertensive crisis. Gastrointestinal Perforation: Permanently discontinue if perforation occurs. Wound Healing: Withhold sorafenib for at least 3 days prior to elective surgery; resume only after the surgical wound is fully healed. Fetal/Embryonic Toxicity: Can cause fetal harm.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most common drug-related adverse events include diarrhea, rash, alopecia, and hand-foot skin reaction (HFSR). Laboratory Abnormalities: Lipase and amylase elevation is common. Clinical Research: In pivotal Phase III clinical trials, sorafenib demonstrated significant overall survival benefits compared to placebo or standard of care in advanced HCC and RCC populations.
- Drug Interactions CYP3A4 Inhibitors/Inducers: Sorafenib is metabolized by CYP3A4. Strong CYP3A4 inhibitors may increase sorafenib exposure, while strong inducers may decrease it. Warfarin: Sorafenib may increase the risk of bleeding in patients taking warfarin or other vitamin K antagonists.
- Pharmaceutical Information Composition: Active ingredient is Sorafenib Tosylate. Appearance: Red, round, film-coated tablets. Storage: Store at controlled room temperature in the original packaging.
Nexavar Sorafenib Tosylate Tablets
Brand Name: 多吉美 ®（Nexavar®）
Generic Name: Sorafenib Tosylate
Strength: 0.2 g (200 mg) per tablet, 60 tablets per box
Manufacturer: Bayer AG
Marketing Authorization Holder: Bayer AG
Approval Date in China: November 29, 2006
Registration Number: 国药准字H20060296
Storage: Store tightly sealed below 25°C, keep out of reach of children. Refer to the full package insert for detailed storage specifications.
Price&Cost:Contact Us now for the best price of Sorafenib Tosylate（Nexavar）
Only logged in customers who have purchased this product may leave a review.
Reviews
There are no reviews yet.