Indications

Sunitinib 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 Sunitinib 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.

Composition

Pharmacology

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.

Dosage & 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.

Contraindications

It is contraindicated in patients with known hypersensitivity to Sunitinib or any other components of this product.

Side Effects

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.

Pregnancy & 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. 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.

Precautions & Warnings

Therapeutic Class

Targeted Cancer Therapy

Storage Conditions

Store at 25°C in a cool and dry place, away from light. Keep out of the reach of children.