Sunitinib

DEA Class; Rx

Common Brand Names; Sutent

• Antineoplastics, Tyrosine Kinase Inhibitor; 
• Antineoplastics, VEGF Inhibitor

Indicated for treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate

Indicated for treatment of advanced renal cell carcinoma (RCC)

Indicated for progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease

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• Dyspepsia (MRCC 46%)
• Altered taste (MRCC 43%; GIST 21%)
• Fatigue (GIST 42%; MRCC 74%)
• Diarrhea (GIST 40%; MRCC 55%)
• Rash (MRCC 38%; GIST 14%)
• Vomiting (MRCC 37%; GIST 24%)
• Constipation (MRCC 34%; GIST 20%)
• Skin discoloration (MRCC 33%; GIST 30%)
• Abdominal pain (GIST 33%; MRCC 20%)
• Nausea (GIST 31%; MRCC 54%)
• Anorexia (MRCC 31%; GIST 33%)
• Mucositis/stomatitis (GIST 29%; MRCC 53%)
• Dyspnea (MRCC 28%; GIST 10%)
• HTN (MRCC 28%; GIST 15%)
• Arthralgia (MRCC 28%; GIST 12%)
• Bleeding (MRCC 26%; GIST 18%)
• Headache (MRCC 25%; GIST 13%)
• Asthenia (GIST 22%)
• Lymphopenia (MRCC 21%)
• Fever (GIST 18%; MRCC 15%)
• Limb pain (MRCC 18%)
• Back pain (MRCC 17%; GIST 11%)
• Myalgia (MRCC 17%; GIST 14%)
• Cough (MRCC 17%; GIST 8%)
• Dry skin (17%)
• Hair color changes (17%)
• Neutropenia (MRCC 13%; GIST 11%)
• Alopecia (MRCC 12%)
• Hand-foot syndrome (MRCC 12%; GIST 14%)
• Dehydration (MRCC 11%)

Fatal liver failure has been observed (see Black Box Warnings)

Hemorrhagic events, some of which were fatal, have involved gastrointestinal tract, respiratory tract, tumor, urinary tract, and brain; interrupt therapy for Grade 3 or 4 hemorrhagic events until resolution to Grade less than or equal to 1 or baseline, then resume at a reduced dose; discontinue therapy in patients without resolution of Grade 3 or 4 hemorrhagic events; perform serial complete blood counts and physical examinations

Adrenal hemorrhage observed in animal studies; monitor adrenal function in case of stress such as surgery, trauma or severe infection

Monitor urine protein; interrupt treatment for 24-hr urine protein ≥3 g; discontinue for repeat episodes of protein ≥3 g despite dose reductions or nephrotic syndrome

Hyperthyroidism, some followed by hypothyroidism, have been reported; monitor thyroid function at baseline, periodically during treatment and as clinically indicated; initiate and/or adjust therapies for thyroid dysfunction as appropriate

Impaired wound healing reported; withhold therapy for at least 3 weeks prior to elective surgery; do not administer for at least 2 weeks following major surgery and until adequate wound healing; safety of resumption of therapy after resolution of wound healing complications has not been established

Severe cutaneous reactions have been reported, including cases of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, some of which were fatal; necrotizing fasciitis, including fatal cases, also reported

Advise women of childbearing potential of potential hazard to fetus

Prolonged QT intervals and Torsade de Pointes may occur in a dose-dependent manner; use caution in patients at higher risk for developing QT interval prolongation; consider monitoring with on-treatment ECG and electrolytes

Based on animal reproduction studies and its mechanism of action, fetal harm may occur when administered to pregnant females

There is no information regarding the presence of sunitinib and its metabolites in human milk

Sunitinib malate

capsule

• 12.5mg
• 25mg
• 37.5mg
• 50mg