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Shengfuda (Sunitinib Malate Capsules)
Sunitinib Malate Capsules

English Name: Sunitinib Malate Capsules

Chinese Pinyin: Pingguosuan Shunitini Jiaonang

The main ingredient of this product is sunitinib malate.

Chemical Name: (Z)-N-[2-(diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indole-3-ylidene)methyl]-2,4-dimethyl-3-carbamoyl-1H-pyrrole malate 


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【Name】

Common Name: Sunitinib Malate Capsules

English Name: Sunitinib Malate Capsules

Chinese Pinyin: Pingguosuan Shunitini Jiaonang 

【Ingredients】

Main Ingredient: sunitinib malate

Chemical Name: (Z)-N-[2-(diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indole-3-ylidene)methyl]-2,4-dimethyl-3-carbamoyl-1H-pyrrole malate

Structural Formula:

Molecular Formula: C22H27FN4O2·C4H6O5

Molecular Weight: 532.56

Excipients: mannitol, polyvinylpyrrolidone, crosslinked sodium carboxymethyl cellulose, and magnesium stearate 

【Description】

This product is a capsule with the content of yellow to orange granules. 

【Indication】

1) Inoperable advanced renal cell carcinoma (RCC)

2) Imatinib mesylate failed or intolerable gastrointestinal stromal tumor (GIST)

3) Unresectable, metastatic well-differentiated advanced pancreatic neuroendocrine tumor (PNET) in adult patients. 

【Strength】

12.5mg (as sunitinib) 

【Dosage and Administration】

The recommended dose of sunitinib in the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma is 50mg orally once daily for 4 weeks with a 2-week discontinuation period (4/2 dosing regimen).

For pancreatic neuroendocrine tumor, the recommended dose of sunitinib is 37.5mg orally once daily with no discontinuation period.

It can be taken with or without food. 


Note: Please refer to the Product Manual for details. 


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