Resinib capsule is indicated in- Gastrointestinal Stromal Tumor (GIST) : It is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to Imatinib Mesylate. Advanced Renal Cell Carcinoma (RCC) : ... Read more Resinib capsule is indicated in- Gastrointestinal Stromal Tumor (GIST) : It is indicated for the treatment of gastrointestinal stromal tumor 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 Treatment of 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.
Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs), some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. Sunitinib was evaluated for its inhibitory activity against a variety of kinases (>80 kinases) and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET). Sunitinib inhibition of the activity of these RTKs has been demonstrated in biochemical and cellular assays, and inhibition of function has been demonstrated in cell proliferation assays. The primary metabolite exhibits similar potency compared to sunitinib in biochemical and cellular assays.
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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.
The most common side effects are: Hepatotoxicity, Cardiovascular Events, QT Interval Prolongation and Torsade de Pointes, Hypertension, Hemorrhagic Events, Tumor Lysis Syndrome (TLS), Thrombotic Microangiopathy, Proteinuria, Dermatologic Toxicities, Thyroid Dysfunction, Hypoglycemia, Osteonecrosis of the Jaw (ONJ), Wound Healing.
It is contraindicated in patients with known hypersensitivity to Sunitinib or any other components of this product.
Strong CYP3A4 inhibitors such as Ketoconazole may increase Resinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended. Concurrent administration of Sutinib with the strong CYP3A4 inhibitor, Ketoconazole, resulted in 49% and 51% increases in the combined (Resinib + primary active metabolite) Cmax and AUC0-∞ values, respectively, after a single dose of Sutinib in healthy volunteers. Coadministration of Sutinib with strong inhibitors of the CYP3A4 family (e.g., Ketoconazole, Itraconazole, Clarithromycin, Atazanavir, Indinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin, Voriconazole) may increase Resinib concentrations. Grapefruit may also increase plasma s of Resinib. A dose reduction for Sutinib should be considered when it must be coadministered with strong CYP3A4 inhibitors. CYP3A4 Inducers: CYP3A4 inducers such as Rifampin may decrease Resinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme induction potential is recommended. Concurrent administration of Sutinib with the strong CYP3A4 inducer, Rifampin, resulted in a 23% and 46% reduction in the combined (Resinib + primary active metabolite) Cmax and AUC0-∞ values, respectively, after a single dose of Sutinib in healthy volunteers. Coadministration of Sutinib with inducers of the CYP3A4 family (e.g., Dexamethasone, Phenytoin, Carbamazepine, Rifampin, Rifabutin, Rifapentin, Phenobarbital, St. John’s Wort) may decrease Resinib concentrations. St. John’s Wort may decrease Resinib plasma concentrations unpredictably. Patients receiving Sutinib should not take St. John’s Wort concomitantly. A dose increase for Sutinib should be considered when it must be coadministered with CYP3A4 inducers.