Lucius LuciRegor Regorafenib 40mg

Product Information

• Product name: LuciRegor Regorafenib 40mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Regorafenib
• Current strength: 40mg
• SKU: LU-ITEM-93
• Site category: colorectal cancer, other cancer

Product Summary

LuciRegor Regorafenib 40mg 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

Regorafenib is the active ingredient used for this product page. Public prescribing information for Regorafenib 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

Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. Regorafenib also demonstrated anti-metastatic activity in a mouse xenograft model and two mouse orthotopic models of human colorectal carcinoma.

Reference Indications

Regorafenib is a kinase inhibitor indicated for the treatment of adult patients with: Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib 1.1 Colorectal Cancer Regorafenib is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy.

Reference Dosage and Administration

Recommended dose: 160 mg orally, once daily for the first 21 days of each 28-day cycle. Take Regorafenib after a low-fat meal.

With this 40mg product, that corresponds to 4 x 40mg tablets when that reference dose is clinically appropriate.

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

Important Safety Information

WARNING: HEPATOTOXICITY Severe and sometimes fatal hepatotoxicity has occurred in clinical trials . Monitor hepatic function prior to and during treatment . Interrupt and then reduce or discontinue Regorafenib for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence . WARNING: HEPATOTOXICITY See for complete boxed warning. Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Regorafenib for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence. Hepatotoxicity : Monitor liver function tests.

Common Adverse Reactions and Monitoring

The data described in the section reflect exposure to Regorafenib in more than 4800 patients who were enrolled in four randomized, placebo-controlled trials (n=1142), an expanded access program (CONSIGN, n=2864), or single arm clinical trials (single agent or in combination with other agents). There were 4518 patients who received Regorafenib as a single agent; the distribution of underlying malignancies was 80% CRC, 4% GIST, 10% HCC, 6% other solid tumors; and 74% were White, 11% Asian, and 15% race not known. Among these 4518 patients, 83% received Regorafenib for at least 21 days and 20% received Regorafenib for 6 months or longer.

Drug Interactions and Special Populations

Strong CYP3A4 inducers: Avoid strong CYP3A4 inducers. Strong CYP3A4 inhibitors: Avoid strong CYP3A4 inhibitors. BCRP substrates: Monitor patients closely for symptoms of increased exposure to BCRP substrates. Avoid concomitant use of Regorafenib with strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. Avoid concomitant use of Regorafenib with strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole). Monitor patients closely for signs and symptoms of exposure related toxicity to the BCRP substrate (e.g. methotrexate, fluvastatin, atorvastatin). Consult the concomitant BCRP substrate product information when considering administration of such products together with Regorafenib.

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: Stivarga 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.