Fenitab 200 mg (Sorafenib) Tablets

Fenitab 200 mg (Sorafenib) Tablets – Advanced Multi-Kinase Inhibitor for Cancer Treatment

Overview

Fenitab 200 mg contains Sorafenib Tosylate, a powerful multi-kinase inhibitor designed specifically for treating unresectable hepatocellular carcinoma (liver cancer) and advanced renal cell carcinoma (kidney cancer). Manufactured by the renowned Eskayef Pharmaceuticals Ltd and supplied globally by Saif Pharma, Fenitab represents a significant advancement in targeted cancer therapy. This innovative medication works by inhibiting multiple cellular pathways involved in tumor growth, proliferation, and angiogenesis (formation of new blood vessels), offering hope to patients with these challenging cancers.

Mechanism of Action

Sorafenib, the active ingredient in Fenitab, functions as a potent multi-kinase inhibitor that targets both tumor cell proliferation and tumor angiogenesis. This dual action is achieved through inhibition of multiple targets:

Intracellular Kinases:

• CRAF
• BRAF and mutant BRAF

Cell Surface Kinases:

• KIT
• FLT-3
• RET
• VEGFR-1, VEGFR-2, VEGFR-3 (vascular endothelial growth factor receptors)
• PDGFR-β (platelet-derived growth factor receptor)

By inhibiting these kinases, Fenitab disrupts critical signaling pathways involved in tumor cell growth and survival. Additionally, by targeting VEGFR and PDGFR-β, Sorafenib blocks the formation of new blood vessels that tumors need to grow and spread, effectively cutting off their nutrient and oxygen supply.

Clinical Applications

Fenitab 200 mg is indicated for the treatment of:

• Unresectable Hepatocellular Carcinoma (HCC): For patients with liver cancer that cannot be removed through surgery
• Advanced Renal Cell Carcinoma (RCC): For patients with advanced kidney cancer

Clinical studies have demonstrated Sorafenib’s efficacy in extending progression-free survival and overall survival in patients with these challenging malignancies, particularly in cases where surgical intervention is not possible or has been unsuccessful.

Pharmacokinetics

Understanding the pharmacokinetic profile of Fenitab helps healthcare providers optimize treatment:

• Absorption: Following oral administration, Sorafenib reaches peak plasma levels in approximately 3 hours
• Bioavailability: The relative bioavailability is 38-49% compared to oral solution
• Food Effect: Taking Fenitab with a high-fat meal reduces bioavailability by 29%, which is why it’s recommended to take it without food
• Half-life: The mean elimination half-life is approximately 25-48 hours
• Steady State: Achieved within 7 days of regular dosing
• Metabolism: Primarily in the liver via CYP3A4 oxidation and UGT1A9 glucuronidation
• Elimination: Predominantly excreted in feces (77%) with some elimination through urine (19%) as metabolites

Dosage & Administration

The recommended dosage of Fenitab is:

• 400 mg (2 tablets) taken orally twice daily without food
• Tablets should be taken approximately 12 hours apart
• Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs

Dose modifications may be necessary to manage side effects:

• Dose may be reduced to 400 mg once daily
• Further reduction to 400 mg every other day may be considered if needed
• Treatment interruption may be required for severe adverse reactions

Product Quality Assurance

Manufactured by Eskayef Pharmaceuticals Ltd, a leading pharmaceutical company with over three decades of excellence, Fenitab adheres to stringent quality control standards. Each film-coated tablet contains Sorafenib Tosylate INN equivalent to 200 mg of Sorafenib, ensuring consistent potency and efficacy. The product is packaged in convenient strips of 4 tablets, with seven strips (28 tablets) per box, providing a week’s supply at standard dosing.

Global Availability

Through Saif Pharma’s extensive supply network spanning over 60 countries, Fenitab 200 mg is accessible to cancer patients worldwide, including major markets such as:

• United States
• Canada
• Saudi Arabia
• United Arab Emirates
• China
• India
• Pakistan

This global reach ensures that patients across diverse geographic regions can access this important treatment option consistently.

Advantages of Fenitab

1. Dual Mechanism: Targets both tumor cell proliferation and angiogenesis for comprehensive anti-cancer activity
2. Multi-Kinase Inhibition: Affects multiple pathways critical for tumor growth and survival
3. Oral Administration: Convenient twice-daily dosing that patients can take at home
4. Established Efficacy: Proven effectiveness in unresectable liver cancer and advanced kidney cancer
5. Quality Manufacturing: Produced by Eskayef Pharmaceuticals with rigorous quality standards
6. Global Supply: Available worldwide through Saif Pharma’s established supply network
7. Treatment Option: Provides therapy for patients with limited alternatives due to unresectable disease

Important Precautions and Considerations

Safety Profile

Patients taking Fenitab may experience side effects including:

• Fatigue and weight loss
• Skin reactions (rash, hand-foot skin reaction, alopecia)
• Gastrointestinal effects (diarrhea, anorexia, nausea, abdominal pain)

Special Precautions

Healthcare providers should be aware of important considerations when prescribing Fenitab:

• Cardiac Events: Cardiac ischemia or infarction may occur; temporary or permanent discontinuation should be considered if detected
• Bleeding Risk: If bleeding requires medical intervention, discontinuation may be necessary
• Hypertension: Monitor blood pressure weekly during the first 6 weeks and periodically thereafter
• Skin Toxicity: Hand-foot skin reaction and rash may require dose modifications or supportive care
• Gastrointestinal Perforation: Though uncommon, this serious complication requires discontinuation of therapy
• Surgery: Temporary interruption is recommended for patients undergoing major surgical procedures
• Pregnancy: Category D medication that may cause fetal harm; women of childbearing potential should avoid pregnancy

Drug Interactions

Fenitab has several important drug interactions healthcare providers should consider:

• Carboplatin and Paclitaxel (contraindicated in squamous cell lung cancer)
• UGT1A1 substrates such as irinotecan
• Docetaxel and doxorubicin (increased systemic exposure)
• CYP2B6 and CYP2C8 substrates
• CYP3A4 inducers (may decrease Sorafenib concentrations)

Storage Recommendations

For optimal stability and efficacy, Fenitab should be:

• Stored below 30°C
• Protected from light and moisture
• Kept out of reach of children

About the Manufacturer

Eskayef Pharmaceuticals Ltd began its journey in 1990 when Bangladesh operations of SK&F, USA were acquired by the respected Transcom Group. For over 31 years, Eskayef has built a reputation for premium quality pharmaceuticals, serving both domestic and international markets with world-class medicines.

About the Supplier

Founded in 2014, Saif Pharma has established itself as a leading supplier, trader, and provider of oncology medicines. With a mission centered on providing high-quality, affordable cancer treatments, Saif Pharma has earned a prestigious market position by prioritizing dependability and patient access. Their extensive global supply network ensures that vital medications like Fenitab reach patients worldwide, reducing suffering and improving treatment outcomes.

Commitment to Cancer Care

Both Eskayef Pharmaceuticals and Saif Pharma share a commitment to advancing cancer care through high-quality, accessible medications. Fenitab 200 mg represents this shared mission, offering a scientifically advanced treatment option that can significantly improve outcomes for patients with unresectable liver cancer and advanced kidney cancer.

For more information about Fenitab 200 mg (Sorafenib) or to inquire about availability in your region, please visit www.saifpharma.com or consult with your healthcare provider.