Lucius LuciSora Sorafenib

Product Information

• Product name: LuciSora Sorafenib as shown on package
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Sorafenib
• Current strength: as shown on package
• SKU: LU-ITEM-108
• Site category: kidney cancer, liver cancer, other cancer, thyroid cancer

Product Summary

LuciSora Sorafenib as shown on package is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Sorafenib is the active ingredient used for this product page. Public prescribing information for Sorafenib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (c-CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT- 3, RET, RET/PTC, VEGFR-1, VEGFR- 2, VEGFR- 3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis and apoptosis. Sorafenib inhibited tumor growth of HCC and DTC human tumor xenografts in immunocompromised mice.

Reference Indications

Sorafenib tablets are a kinase inhibitor indicated for the treatment of Unresectable hepatocellular carcinoma Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment 1.1 Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

Reference Dosage and Administration

Recommended dosage is 400 mg orally twice daily without food.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Cardiovascular Events: Consider temporary or permanent discontinuation of Sorafenib tablets.(2.2, 5.1) Hemorrhage: Discontinue Sorafenib tablets if needed. Hypertension: Monitor blood pressure weekly during the first 6 weeks and periodically thereafter. Consider temporary or permanent discontinuation for severe or persistent hypertension despite antihypertensive therapy. Dermatologic Toxicities: Interrupt and/or decrease dose. Discontinue for severe or persistent reactions, or if Stevens-Johnson syndrome and toxic epidermal necrolysis is suspected. Gastrointestinal Perforation: Discontinue Sorafenib tablets. Risk of Impaired Wound Healing: Withhold Sorafenib tablets for at least 10 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing.

Common Adverse Reactions and Monitoring

Hypertension was reported in 9% of patients treated with Sorafenib tablets and 4% of those receiving placebo. Grade 3 hypertension was reported in 4% of Sorafenib tablets -treated patients and 1% of those receiving placebo. Hemorrhage/bleeding was reported in 18% of those receiving Sorafenib tablets and 20% of patients receiving placebo. The rates of Grade 3 and 4 bleeding were also higher in patients receiving placebo (Grade 3 – 3% Sorafenib tablets and 5% placebo and Grade 4 – 2% Sorafenib tablets and 4% placebo). Bleeding from esophageal varices was reported in 2.4% in Sorafenib tablets -treated patients and 4% of patients receiving placebo.

Drug Interactions and Special Populations

Strong CYP3A Inducers: Avoid strong CYP3A4 inducers. Avoid concomitant use of Sorafenib tablets with strong CYP3A4 inducers, when possible, because these drugs can decrease the systemic exposure to Sorafenib. Neomycin The concomitant use of Sorafenib tablets with neomycin decreased the mean AUC of Sorafenib, which may decrease the antitumor activity. Avoid concomitant use of Sorafenib tablets with neomycin. The effects of other antibiotics on the pharmacokinetics of Sorafenib have not been studied . Monitor INR and for clinical bleeding episodes in patients taking warfarin while receiving Sorafenib tablets . Avoid coadministration of Sorafenib tablets with medicinal products with a known potential to prolong QT/QTc interval .

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: sorafenib public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.