sunitinib 12.5 mg
1 INDICATIONS AND USAGE Sunitinib malate capsules are a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ( 1.3 ) • treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. ( 1.4 ) 1.1 Gastrointestinal Stromal Tumor Sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. 1.2 Advanced Renal Cell Carcinoma Sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC). 1.3 Adjuvant Treatment of Renal Cell Carcinoma Sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. 1.4 Advanced Pancreatic Neuroendocrine Tumors Sunitinib malate capsules are indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.
mylan pharmaceuticals inc.
CAPSULE BROWN Mylan SM 12 5
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16 HOW SUPPLIED/STORAGE AND HANDLING
SUNITINIB MALATE capsules are available containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib equivalent to 16.7 mg, 33.4 mg, 50.1 mg or 66.8 mg of
SUNITINIB MALATE, respectively. The 12.5 mg capsules are hard-shell gelatin capsules with a pink-brown opaque cap and pink-brown opaque body filled with yellow to orange powder. The capsules are axially printed with MYLAN over SM 12.5 in black ink on cap and body. They are available as follows: NDC 0378-6678-28 bottles of 28 capsules The 25 mg capsules are hard-shell gelatin capsules with a yellow opaque cap and pink-brown opaque body filled with yellow to orange powder. The capsules are axially printed with MYLAN over SM 25 in black ink on cap and body. They are available as follows: NDC 0378-6679-28 bottles of 28 capsules The 37.5 mg capsules are hard-shell gelatin capsules with an ivory opaque cap and ivory opaque body filled with yellow to orange powder. The capsules are axially printed with MYLAN over SM 37.5 in black ink on cap and body. They are available as follows: NDC 0378-6681-28 bottles of 28 capsules The 50 mg capsules are hard-shell gelatin capsules with a yellow opaque cap and yellow opaque body filled with yellow to orange powder. The capsules are axially printed with MYLAN over SM 50 in black ink on cap and body. They are available as follows: NDC 0378-6680-28 bottles of 28 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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