Gastrointestinal stromal tumor: After disease progression on or intolerance to imatinib mesylate
Advanced renal cell carcinoma: For clear cell carcinoma in pathology
#仿單變更2022

Antineoplastic Agent, Vascular Endothelial Growth Factor (VEGF) Inhibitor
Sunitinib malate is a multi-targeting receptor tyrosine kinase inhibitor, decreasing tumor cell proliferation and angiogenesis

Distribution:
1. Protein-binding: 95% (sunitinib) and 90% (primary metabolite)
2. The apparent volume of distribution: 2230 L
Metabolism:
Primarily by CYP3A4, to produce its primary active metabolite, which is further metabolized also by CYP3A4
Elimination:
Primarily via feces (61%)
Elimination half-life:
1. Sunitinib: 40 to 60 hrs
2. Sunitinib primary metabolite: 80 to 110 hrs

specific contraindications have not been determined

D

Infant risk cannot be ruled out.

Common:
Fatigue, asthenia, diarrhea, nausea, mucositis, stomatitis, vomiting, dyspepsia, abdominal pain, constipation, rash, hand-foot syndrome, skin discoloration, altered taste, anorexia, anemia, bleeding, leukopenia, lymphocytopenia, increased uric acid level
Serious:
Left ventricular dysfunction, QT interval prolongation, hemorrhage, hypertension, severe hypothyroidism, aortic dissection, hemangioma<20220317>

Administration:
Sunitinib may be taken with or without food. Swallow the capsule whole. Do not crush, break, or chew it.
Dosage:
50 mg orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off.
Dose adjustment:
1. Use with strong CYP3A4 inhibitors (eg, ketoconazole): reduce to a minimum of 37.5 mg ORALLY daily
2. Use with strong CYP3A4 inducers (eg, rifampin): increase to a maximum of 87.5 mg ORALLY daily
3. Ejection fraction of 20-50% below baseline but no clinical evidence of congestive heart failure: reduce the dose or interrupt treatment
4. Symptoms of congestive heart failure: Discontinue sunitinib
5. Severe hypertension: Discontinue if severe hypertension develops, may restart once hypertension is controlled

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Dose adjustment of Sutent in response to adverse reactions:<20230606>

Indications	GIST	Advanced RCC	pNET
first reduction	37.5 mg/day	37.5 mg/day	25 mg/day
second reduction	25 mg/day	25 mg/day ( Auxiliary RCC does not apply)	not apply