Sorafenib Tablets

Sorafenib Tablets

Classification: Anticancer Medicine / Multikinase Inhibitor

About Sorafenib Tablets

Sorafenib is an orally bioavailable multi-kinase inhibitor targeting serine/threonine and receptor tyrosine kinases, widely prescribed worldwide for unresectable hepatocellular carcinoma, advanced renal cell carcinoma, and differentiated thyroid carcinoma.

Sorafekast (Sorafenib Tablets) – Manufactured by Aprazer Healthcare

Sorafekast (Sorafenib 200 mg) is manufactured by Aprazer Healthcare under stringent WHO-GMP guidelines. Built upon an established international reputation, Aprazer Healthcare supplies high-quality, cost-effective chemotherapy, targeted therapies, and specialty oncology medicines across Asia, Africa, Europe, and the Americas.

Approved Indications & Uses of Sorafenib Tablets

Sorafenib is clinically approved for three primary cancer types:

• Unresectable Hepatocellular Carcinoma (HCC): Standard systemic targeted therapy for patients with advanced, unresectable primary liver cancer.
• Advanced Renal Cell Carcinoma (RCC): Treatment of patients with advanced renal cell carcinoma who have failed prior cytokine or systemic therapy.
• Differentiated Thyroid Carcinoma (DTC): Indicated for locally recurrent or metastatic, progressive differentiated thyroid carcinoma refractory to radioactive iodine (RAI) treatment.

Mechanism of Action (How Sorafenib Works)

Sorafenib is a small-molecule multikinase inhibitor with dual anti-proliferative and anti-angiogenic properties:

• RAF Kinase Inhibition: Targets intracellular serine/threonine kinases CRAF, wild-type BRAF, and mutant V600E BRAF, shutting down the oncogenic RAF/MEK/ERK signaling pathway.
• Receptor Tyrosine Kinase Blockade: Inhibits cell-surface receptors including VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-β, KIT, FLT-3, and RET.
• Vascular Starvation: Suppresses tumor angiogenesis, blocking blood vessel formation and depriving malignant cells of nutrients and oxygen.
• Apoptosis & Tumor Shrinkage: Induces programmed cancer cell death and halts tumor proliferation.

Side Effects of Sorafenib

Common Side Effects:

• Palmar-plantar erythrodysesthesia (hand-foot skin reaction, affecting 30% to 50% of patients)
• Gastrointestinal disturbances: Diarrhea, nausea, vomiting, abdominal cramping
• Generalized fatigue, asthenia, and weakness
• Anorexia and progressive weight loss
• Dermatologic reactions: Alopecia/hair thinning, dry skin, pruritus, and rash
• Hypertension (emerging frequently within the first 6 weeks of therapy)

Serious Adverse Reactions Requiring Immediate Care:

• Cardiac ischemia or myocardial infarction
• Hypertensive crisis and posterior reversible leukoencephalopathy syndrome (PRES)
• Gastrointestinal perforation and fistulae formation
• Hemorrhagic complications (severe bleeding from GI, pulmonary, or cerebral sites)
• Drug-induced liver injury (DILI) and acute hepatic failure
• QTc interval prolongation and ventricular arrhythmias

Clinical Precautions & Safe Administration

• Take on an Empty Stomach: Sorafenib tablets must be administered on an empty stomach (at least 1 hour before or 2 hours after meals). High-fat food significantly reduces drug bioavailability.
• Swallow Whole: Swallow tablets whole with water; never crush, chew, or split the tablets.
• Wound Healing: Withhold Sorafenib at least 10–14 days prior to elective surgery and major dental procedures due to impaired angiogenesis and wound healing risks.
• Pre-Existing Conditions: Exercise caution in patients with coronary heart disease, cardiac arrhythmias, bleeding disorders, gastrointestinal ulcers, and liver impairment.

Warnings & Contraindications

• Squamous Cell Lung Cancer Warning: Sorafenib is contraindicated in combination with carboplatin and paclitaxel in patients with squamous cell lung cancer due to increased mortality risks.
• Pregnancy & Fetal Risk: Strictly contraindicated during pregnancy; causes severe embryofetal toxicity and birth defects. Reliable contraception is mandatory for female patients and male patients with female partners during treatment and for at least 6 months post-therapy.
• Lactation: Avoid breastfeeding during therapy and for 2 weeks following the final dose.
• Hypersensitivity: Contraindicated in patients with severe hypersensitivity to sorafenib or its excipients.

Drug Interactions

• Chemotherapy Contraindications: Must not be combined with carboplatin and paclitaxel in squamous cell lung cancer.
• Strong CYP3A4 Inducers: Rifampin, carbamazepine, phenytoin, phenobarbital, and St. John's Wort accelerate sorafenib clearance, drastically lowering blood levels.
• QT-Prolonging Medications: Co-administration with pimozide, thioridazine, dronedarone, lefamulin, or antiarrhythmics increases torsades de pointes risk.
• Warfarin: Concurrent use elevates bleeding risk; closely monitor PT/INR and adjust anticoagulant dosing.
• Neomycin: Oral non-absorbable neomycin decreases the systemic bioavailability of sorafenib.

Important Monitoring Parameters

• Blood pressure: Weekly during the first 6 weeks of therapy, then regularly; control with standard antihypertensives.
• Liver function tests: ALT, AST, alkaline phosphatase, and bilirubin periodically.
• ECG and serum electrolytes: Check QTc intervals and monitor potassium, magnesium, and calcium.
• Serum lipase and amylase: Periodic evaluation for pancreatitis.
• Dermatologic examination: Early intervention with moisturizing keratolytics for hand-foot skin reactions.

Storage Information

Store Sorafenib tablets at controlled room temperature (20°C to 25°C / 68°F to 77°F) in a dry place. Protect from moisture and extreme heat. Keep out of reach of children.