Dosage & Administration
Sutent Prescribing Information
SUTENT can cause severe hepatotoxicity, resulting in liver failure or death. In the pooled safety population, liver failure occurred in <1% of patients in clinical trials. Liver failure include jaundiced, elevated transaminases and/or hyperbilirubinemia in conjunction with encephalopathy, coagulopathy, and/or renal failure.
Monitor liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and bilirubin) at baseline, during each cycle, and as clinically indicated. Interrupt SUTENT for Grade 3 hepatotoxicity until resolution to Grade ≤1 or baseline, then resume SUTENT at a reduced dose.
Discontinue SUTENT in patients with Grade 4 hepatotoxicity, in patients without resolution of Grade 3 hepatotoxicity, in patients who subsequently experience severe changes in liver function tests and in patients who have other signs and symptoms of liver failure. Safety in patients with ALT or AST >2.5 × upper limit of normal (ULN) or with >5 × ULN and liver metastases has not been established.
SUTENT is 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 Gastrointestinal Stromal TumorSUTENT is indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
• treatment of adult patients with advanced renal cell carcinoma (RCC). ()1.2 Advanced Renal Cell CarcinomaSUTENT is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC).
• adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ()1.3 Adjuvant Treatment of Renal Cell CarcinomaSUTENT is indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
• treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. ()1.4 Advanced Pancreatic Neuroendocrine TumorsSUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.
• The recommended dosage is 50 mg orally once daily for the first 4 weeks of each 6-week cycle (Schedule 4/2). ()2.1 Recommended Dosage for GIST and Advanced RCCThe recommended dosage of SUTENT 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. SUTENT may be taken with or without food.
• The recommended dosage is 50 mg orally once daily for the first 4 weeks of a 6-week cycle (Schedule 4/2) for a maximum of 9 cycles. ()2.2 Recommended Dosage for Adjuvant Treatment of RCCThe recommended dosage of SUTENT 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. SUTENT may be taken with or without food.
• The recommended dosage is 37.5 mg orally once daily. ()2.3 Recommended Dosage for pNETThe recommended dosage of SUTENT for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily until disease progression or unacceptable toxicity. SUTENT may be taken with or without food.
Capsules, hard gelatin:
• 12.5 mg sunitinib: orange cap and orange body, printed with white ink “Pfizer” on the cap and “STN 12.5 mg” on the body.• 25 mg sunitinib: caramel cap and orange body, printed with white ink “Pfizer” on the cap and “STN 25 mg” on the body.• 37.5 mg sunitinib: yellow cap and yellow body, printed with black ink “Pfizer” on the cap and “STN 37.5 mg” on the body.• 50 mg sunitinib: caramel top and caramel body, printed with white ink “Pfizer” on the cap and “STN 50 mg” on the body.
• Lactation: Advise not to breastfeed. ()8.2 LactationThere is no information regarding the presence of sunitinib and its metabolites in human milk. Sunitinib and its metabolites were excreted in rat milk at concentrations up to 12-fold higher than in plasma
(see Data). Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with SUTENT and for at least 4 weeks after the last dose.DataAnimal DataIn lactating female rats administered 15 mg/kg, sunitinib and its metabolites were excreted in milk at concentrations up to 12-fold higher than in plasma.
None.