Sunitinib Malate
SUNITINIB MALATE- sunitinib malate capsule
NorthStar RxLLC
WARNING: HEPATOTOXICITY
Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib recommended [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage for GIST and Advanced RCC
The recommended dosage of sunitinib malate capsules for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) until disease progression or unacceptable toxicity. Sunitinib malate capsules may be taken with or without food.
2.2 Recommended Dosage for Adjuvant Treatment of RCC
The recommended dosage of sunitinib malate capsules 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. Sunitinib malate capsules may be taken with or without food.
2.3 Recommended Dosage for pNET
The recommended dosage of sunitinib malate capsules for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily until disease progression or unacceptable toxicity. Sunitinib malate capsules may be taken with or without food.
2.4 Dosage Modifications for Adverse Reactions
To manage adverse reactions, the recommended dosage modifications are provided in Table 1. Table 2 provides the recommended dosage reductions of sunitinib malate capsules for adverse reactions.
Table 1. Recommended Dosage Reductions of Sunitinib Malate Capsules for Adverse Reactions
Indications | GIST | RCC | pNET | |
Advanced RCC | Adjuvant RCC | |||
First dose reduction | 37.5 mg once daily | 37.5 mg once daily | 37.5 mg once daily | 25 mg once daily |
Second dose reduction | 25 mg once daily | 25 mg once daily | NA | NA |
Table 2. Recommended Dosage Modifications for Sunitinib Malate Capsules for Adverse Reactions
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