Sunitinib Malate INN \n \nComposition:?Each capsule contains Sunitinib 50 mg as Sunitinib Malate INN. \n \nIndications: Gastrointestinal Stromal Tumors (GIST):?It is indicated for the treatment of gastrointestinal stromal tumors after disease progression on or intolerance to Imatinib Mesylate.?Advanced Renal Cell Carcinoma (RCC):?It is indicated for the treatment of advanced renal cell carcinoma.?Adjuvant?Renal Cell Carcinoma (RCC):?It is indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.?Advanced Pancreatic Neuroendocrine Tumors (pNET):?It is indicated for the treatment of progressive, well- differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease. \n \nDosage and administration: Recommended Dose for GIST and Advanced RCC:?The recommended dose of Sutinib for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is one 50 mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2). It may be taken with or without food.?Recommended Dose for Adjuvant Treatment of RCC:?The recommended dose of Sutinib for the adjuvant treatment of RCC is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2), for nine 6-week cycles. It may be taken with or without food.?Recommended Dose for pNET:The recommended dose of Sutinib for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily continuously without a scheduled off-treatment period. It may be taken with or without food. Or, as directed by the registered physician. \n \nUse in pregnancy and lactation:?It can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. If it is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.?Lactation:?There is no information regarding the presence of Sunitinib and its metabolites in human milk. Because of the potential for serious adverse reactions in breastfed infants from Sutinib, a lactating woman should be advised not to breastfeed during treatment with Sutinib and for at least 4 weeks after the last dose. \n \nPackaing:?Each box contains 1x7?s capsules in blister pack.