Sorasiba 200 mg (Tablet)

Indications

• Treatment of unresectable hepatocellular carcinoma (HCC)
• Treatment of advanced renal cell carcinoma (RCC)

Pharmacology

• Kinase inhibitor
• Decreases tumor cell proliferation
• Inhibits multiple intracellular and cell surface kinases
• Involved in tumor cell signaling, angiogenesis, and apoptosis
• Inhibits tumor growth and angiogenesis in various human tumor xenografts

Dosage & Administration

• Recommended daily dose of 400 mg tablets taken twice daily without food
• Treatment continuation until clinical benefit or unacceptable toxicity
• Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction
• Missed doses management

Interaction

• Contraindications with specific drug combinations
• Potential impact on systemic exposure to substrates of UGT1A1, UGT1A9, CYP2B6, CYP2C8, and CYP3A4
• Effect on metabolism and exposure of co-administered drugs
• Inhibition of P-glycoprotein
• No impact on CYP enzyme induction

Contraindications

• Severe hypersensitivity to Sorafenib or any other component
• Contraindication in combination with carboplatin and paclitaxel in patients with squamous cell lung cancer

Side Effects

• Serious adverse reactions including cardiac ischemia, infarction, hemorrhage, hypertension, hand-foot skin reaction, rash, gastrointestinal perforation, wound healing complications

Pregnancy & Lactation

• Potential fetal harm
• Advice for women of childbearing potential to avoid pregnancy while on Sorafenib

Precautions & Warnings

• Recommendations for temporary or permanent discontinuation in case of specific adverse events
• Monitoring of patients taking concomitant warfarin
• Use of Sorafenib in combination with Carboplatin and Paclitaxel in Non-small Cell Lung Cancer
• Warnings related to hepatic impairment and drug interactions

Use in Special Populations

• Not studied in pediatric patients
• No differences in safety or efficacy between older and younger patients
• No dose adjustment for renal impairment
• Lower AUC in mild and moderate hepatic impairment

Overdose Effects

• No specific treatment for overdose observed in clinical studies
• Mostly observed adverse reactions at highest clinical dose

Therapeutic Class

• Targeted Cancer Therapy

Storage Conditions

• Store at room temperature below 30°C
• Do not remove desiccant
• Dispense in original bottle

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