LuciSora Sorafenib Sorafenat Soranib Soranix Nexavar 200mg

[Product Name] Sorafenib Tablets

[English Name] LuciSora Sorafenib Tablets

[Active Ingredient] Sorafenib

[Specification] 200 mg × 120 tablets/box

[Manufacturer] Lucius Pharmaceutical (Laos) Co., Ltd.

[Laos National Drug Administration Registration No.] 10L1224/24

[Indications]

1. Treatment of unresectable or metastatic hepatocellular carcinoma (liver cancer).

2. Treatment of unresectable renal cell carcinoma (kidney cancer).

3. Treatment of locally recurrent or metastatic, progressive differentiated thyroid carcinoma that is no longer responsive to radioactive iodine therapy.

[Dosage and Administration]

Recommended Dose: The recommended oral dose of Sorafenib is 0.4 g (2 × 0.2 g) per administration, taken twice daily, either on an empty stomach or with a low-to-moderate fat meal.

Method of Administration: For oral use; swallow with a glass of warm water.

[Adverse Reactions]

Common adverse events associated with Sorafenib include rash, diarrhea, elevated blood pressure, and redness, pain, swelling, or blistering of the palms or soles (Hand-Foot Skin Reaction); for further details, please refer to the full package insert.

[Mechanism of Action]

Sorafenib is an orally active multi-kinase inhibitor that acts to inhibit tumor cell proliferation and tumor angiogenesis. This novel compound was originally discovered by Onyx Pharmaceuticals, with Bayer subsequently participating in its late-stage development (under the code name BAY-43-9006). Initial research identified Sorafenib as an inhibitor of Raf kinase; subsequent studies revealed that the drug also inhibits vascular endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptor-β (PDGFR-β), FMS-like tyrosine kinase-3 (Flt-3), c-Kit protein, and RET receptor tyrosine kinase.

[Precautions]

1. It is recommended to monitor blood pressure weekly during the first 6 weeks of Sorafenib treatment.

2. Risk of Bleeding: As Sorafenib may increase the risk of bleeding in patients, those receiving concomitant treatment with warfarin should undergo regular monitoring of relevant coagulation parameters. Sorafenib should be used with caution in patients with a predisposition to active bleeding (e.g., gastrointestinal bleeding). 3. Reports have indicated that sorafenib may cause myelosuppression (such as neutropenia and thrombocytopenia); therefore, patients with a history of myelosuppressive treatments (including radiotherapy and chemotherapy) should exercise caution when using sorafenib.

4. Patients with active infections (including fungal or viral infections) should undergo appropriate treatment prior to initiating sorafenib therapy. Patients with a history of infection with herpesviruses—such as herpes zoster or herpes simplex—or a history of other viral infections may experience a recurrence of the infection following chemotherapy.

5. Sorafenib may induce thrombocytopenia; therefore, patients should avoid intramuscular injections while taking sorafenib, as they are prone to bleeding, bruising, or hematoma formation.

[Contraindications]

Contraindicated in patients with severe hypersensitivity reactions to sorafenib or to any of the drug's inactive ingredients.

Manufacturer Information:

Company Profile

Lucius Pharmaceutical (Laos) Co., Ltd. (hereinafter referred to as "Lucius Pharmaceutical") is a modern, multinational, high-tech biopharmaceutical enterprise. Currently, the company operates one global R&D center and collaborates with three leading R&D teams within the industry. Specializing in the research and development of complex chemical and biological formulations, the company has achieved technological breakthroughs in key generic drugs. Today, Lucius Pharmaceutical stands as one of the global leaders in generic drug R&D capabilities, enjoying an excellent professional reputation and strong market standing within the industry.

In 2020, Lucius Pharmaceutical officially launched its Asia-Pacific strategy, investing heavily to construct the "Asia-Pacific No. 1 Smart Factory" in Vientiane, the capital of Laos. Built in strict compliance with GMP production standards, the facility incorporates state-of-the-art pharmaceutical manufacturing equipment sourced from China, the United States, Germany, and other nations. It features an international-standard, high-end formulation workshop with an annual generic drug production capacity exceeding 1.5 billion tablets. The company's product portfolio currently encompasses over 200 categories—including oncology, cardiovascular, hematology, diabetes, dermatology, men's health, and anti-aging therapies—and is exported to more than 50 countries and regions across Europe, South America, Africa, the Middle East, India, Vietnam, Nepal, and beyond. Lucius has established a pharmaceutical manufacturing facility in Laos that currently sets the highest standards in the country. Since the completion and commencement of operations at the Lucius Laos plant, the company—in collaboration with the Association of Southeast Asian Nations (ASEAN)—will accelerate its internationalization process, strengthen intellectual cooperation in global pharmaceutical R&D, enrich its product portfolio, and enhance product quality, striving to become a leading global pharmaceutical enterprise.