Regorafenib INN

Regorafenib INN 40 mg

Composition: Each film coated tablet contains Regorafenib 40mg as Regorafenib Monohydrate INN.

Indications: Colorectal Cancer: Renib is indicated for the treatment of 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. Gastrointestinal Stromal Tumors: Renib is indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with Imatinib Mesylate and Sunitinib Malate. Hepatocellular Carcinoma: Renib is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Sorafenib.

Dosage and Administration: The recommended dose is 160 mg Renib (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day cycle. Treatment should be continued until disease progression or unacceptable toxicity. Renib should be taken at the same time each day and swallowed tablet whole with water after a low-fat meal that contains less than 600 calories and less than 30% fat. Two doses of Renib should not be taken on the same day to make up for a missed dose from the previous day. Or, as directed by the registered physicians.

Use in Pregnancy and Lactation: There are no available data on Renib use in pregnant women. Pregnant women should be advised of the potential hazard to a fetus. Lactation: There are no data on the presence of Regorafenib or its metabolites in human milk, the effects of Regorafenib on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Renib, breastfeed should not be done during treatment with Renib and for 2 weeks after the final dose.

Packing: Each box contains 30 tablets in a blister pack.

Prescribing Description

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