Concise Prescribing Info
Sunitinib malate
GI stromal tumor (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance; treatment-naive advanced &/or metastatic renal cell carcinoma (MRCC) & advanced &/or MRCC after failure of cytokine-based therapy; unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) w/ disease progression.
Dosage/Direction for Use
GIST & MRCC 50 mg once daily for 4 consecutive wk, followed by a 2-wk off period (schedule 4/2) to complete 6-wk cycle. Dose modifications in 12.5 mg increments or decrements based on individual safety & tolerability up to 75 mg or down to 25 mg. pNET 37.5 mg once daily w/o scheduled rest period. Dose modifications in 12.5 mg increments or decrements based on individual safety & tolerability. Max: 50 mg daily.
May be taken with or without food.
Special Precautions
Skin discoloration, skin & hair depigmentation & other dermatological effects. Discontinue if signs/symptoms of Stevens-Johnson or erythema multiforme (eg, progressive rash often w/ blisters/mucosal lesions) are present. Hemorrhagic events (GI, resp, tumor, urinary tract, brain, pulmonary). Not for patients w/ NSCLC. GI complications including GI perforation in patients w/ intra-abdominal malignancies. GI events (eg, nausea, diarrhea, stomatitis, dyspepsia & vomiting). Discontinue if symptoms of pancreatitis are present. Monitor liver function tests (ALT, AST, bilirubin levels) before initiation of therapy, during each cycle of therapy & as clinically indicated. Perform CBC at the beginning of each treatment cycle. Patients at risk or w/ history of heart failure, cardiomyopathy, myocardial ischemia & MI; QT interval prolongation, those taking antiarrhythmics or w/ relevant pre-existing cardiac disease, bradycardia or electrolyte disturbances. Discontinue if clinical manifestations of CHF are present. Temporary suspension in patients w/ severe HTN; seizures. Closely observe for signs & symptoms of thyroid dysfunction. Cases of impaired wound healing during therapy, temporary interruption is recommended in patients undergoing major surgical procedures. Avoid invasive dental procedures in patients who have previously or are receiving IV bisphosphonates. Those w/ high tumor burden prior to therapy is at risk of tumor lysis syndrome. Discontinue use if patients develop necrotizing fasciitis, thrombotic microangiopathy, nephrotic syndrome. Risk of hypoglycemia. May impair ability to drive or operate machinery. Women of childbearing potential. Impairment of fertility. Pregnancy & lactation. Childn.
Adverse Reactions
Pulmonary embolism; thrombocytopenia, tumor hemorrhage, febrile neutropenia & HTN. Fatigue; GI disorders eg, diarrhea, nausea, stomatitis, dyspepsia & vomiting; skin discoloration; rash; palmar-plantar erythrodysesthesia; dry skin; hair color changes; mucosal inflammation; asthenia; dysgeusia; anorexia. Epistaxis.
Drug Interactions
Increased plasma conc w/ strong CYP3A4 inhibitors (eg, ritonavir, itraconzaole, erythromycin, clarithromycin, grapefruit juice). Decreased plasma conc w/ CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, phenobarb or St. John's wort).
ATC Classification
L01EX01 - sunitinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Sutent cap 25 mg
28's (P168,405.46/pack)
Sutent cap 12.5 mg
28's (P84,210.62/pack)
Sutent cap 50 mg
28's (P336,795.14/pack)
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