Sorafenib 200 mg Tab

SORAFENIB 200 mg Tablets (Box of 112)

Multikinase Inhibitor – Antineoplastic Agent / Oral Targeted Therapy

ATC Code: L01XE05 WHO Essential Medicines List: ✔️ Yes

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Product Description

Sorafenib is an orally active multi-kinase inhibitor that targets both tumor cell proliferation and tumor angiogenesis. It inhibits multiple intracellular and cell surface kinases, including RAF kinase (CRAF, BRAF), VEGFR-2, VEGFR-3, PDGFR-β, FLT-3, c-KIT, and RET. This broad inhibitory activity disrupts key pathways responsible for tumor growth and vascularization. It is approved for use in multiple advanced or unresectable cancers and is recognized for prolonging overall survival in hepatocellular carcinoma and renal cell carcinoma. Sorafenib is available as a branded or generic formulation depending on manufacturer.

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Available Presentation

• Strength per tablet: 200 mg
• Formulation: Oral film-coated tablet
• Volume: Solid oral dosage form
• Dilution Required: ❌ No
• Packaging: Bottle or blister pack of 112 tablets (4-week cycle at standard dosing)
• Storage: Store at room temperature (15–30°C); protect from moisture and light

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Indications

• Hepatocellular carcinoma (HCC): Unresectable or advanced-stage liver cancer
• Renal cell carcinoma (RCC): Advanced kidney cancer
• Differentiated thyroid carcinoma (DTC): Locally recurrent or metastatic, refractory to radioactive iodine

Uses

• Primary Use: Oncology – Targeted therapy for solid tumors
• Mechanism of Action: Anti-proliferative and anti-angiogenic via kinase inhibition
• Clinical Role: First-line or second-line therapy where conventional cytotoxic regimens are not suitable

Off-label / Investigational Uses

• Soft tissue sarcomas
• Non-small cell lung cancer (NSCLC)
• Colorectal cancer (in combination regimens)
• Pancreatic neuroendocrine tumors
• Ovarian and breast cancers (clinical trial use)

Pediatric Use

❌ Not routinely approved for pediatric use. Investigational studies in hepatoblastoma and pediatric sarcomas are ongoing under clinical protocols.

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Regulatory and Safety Profile

• ATC Code: L01XE05
• WHO Essential Medicines List: ✔️ Yes
• Pharmacologic Class: Tyrosine kinase inhibitor (TKI) / Multikinase inhibitor
• Black Box Warning (U.S. FDA): ❌ No official black box warning, but serious risks require monitoring
  • Cardiovascular events
  • Severe dermatologic reactions
  • Gastrointestinal perforation
• Monitoring: Required during initiation and treatment cycles

Contraindications

• Known hypersensitivity to sorafenib or excipients
• Severe cardiac disease or recent cardiac events
• Uncontrolled hypertension
• Pregnancy (Category D – potential fetal harm)

Common Side Effects

• Hand-foot skin reaction (palmar-plantar erythrodysesthesia)
• Diarrhea, nausea, anorexia
• Fatigue
• Rash, alopecia
• Hypertension
• Elevated liver enzymes

Monitoring Parameters

• Blood pressure (weekly during the first 6 weeks)
• Liver function tests (ALT, AST, bilirubin)
• Electrolytes (especially phosphate and magnesium)
• Thyroid function (especially in DTC patients)
• Dermatologic evaluation for skin toxicity
• ECG for patients with known cardiac disease

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