Names and pronunciation
(soo-nit′-in-ib) Sutent
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Drug reference
(soo-nit′-in-ib) Sutent
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Func. class.: Antineoplastic— miscellaneous
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Chem. class.: Multitargeted Protein- tyrosine kinase inhibitor
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ACTION: Inhibits multiple receptor tyrosine kinases (RTKs); some are responsible for tumor growth
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USES: Gastrointestinal stromal tumors (GIST) after disease progression or intol- erance to imatinib; advanced renal carci- noma, pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced/metastatic disease
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CONTRAINDICATIONS: Preg- nancy, breastfeeding, hypersensitivity Precautions: Children, geriatric patients, active infections, QT prolongation, tors- ades de pointes, stroke, heart failure
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Black Box Warning: Hepatotoxicity Black Box Warning: Hepatotoxicity: monitor LFTs before treatment, monthly; if liver transaminases >5 × IULN, with- hold SUNItinib until transaminase levels return to <2.5 × IULN • Nephrotic syndrome: monitor urinaly- sis and proteinuria • Hand-foot syndrome: redness, swell- ing, numbness, desquamation on palms and soles of the feet may occur days to months after use; if these occur, product should be discontinued • HF: adrenal insufficiency in those ex- periencing trauma • QT prolongation: those taking CYP3A4 inhibitors, those with sinus bradycardia, car- diac disease or electrolyte disturbances are at greater risk; monitor electrolytes, espe- cially magnesium, potassium; monitor ECG • Osteonecrosis of the jaw: dental disease or use of bisphosphonates may increase risk; invasive dental procedures should be avoided • Tumor lysis syndrome: usually in renal cell carcinoma or GI stromal tumor; may be fatal, monitor for hyperkalemia, severe mus- cle weakness, hypocalcemia, hyperphos- phatemia, myopathy, hyperuricemia; monitor serum electrolytes before each dose • Bleeding: epistaxis; rectal, gingival, upper GI, genital, wound bleeding; tu- mor-related hemorrhage may occur rapidly • Nutritious diet with iron, vitamin sup- plement, low fiber, few dairy products • Pregnancy/breastfeeding: do not use in pregnancy, breastfeeding
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SIDE EFFECTS CNS: Headache, dizziness, insomnia, fatigue, reversible posterior leukoen- cephalopathy syndrome (RPLS) CV: Hypertension, left ventricular dysfunc- tion, QT prolongation, torsades de pointes, thrombotic microangiopathy, cardiac arrest, thromboembolism ENDO: Hypo/hyperthyroidism GI: Nausea, hepatotoxicity, vomiting, dys- pepsia, anorexia, abdominal pain, altered taste, constipation, stomatitis, mucositis, pancreatitis, diarrhea, GI bleeding/perforation GU: Nephrotic syndrome HEMA: Neutropenia, thrombocytopenia, hemolytic anemia, leukopenia INTEG: Rash, yellow skin discoloration, depigmentation of hair or skin, alopecia, necrotizing fasciitis, pyoderma gangrenosum MS: Pain, arthralgia, myalgia, myopathy, rhabdomyolysis RESP: Cough, dyspnea, pulmonary embolism SYST: Bleeding, electrolyte abnormalities, hand-foot syndrome, serious infection, tumor lysis syndrome
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INTERACTIONS Increase: microangiopathic hemolytic ane- mia—bevacizumab; avoid concurrent use Increase: QT prolongation—class IA/III antidysrhythmics, some phenothiazines, β agonists, local anesthetics, tricyclics, haloperidol, chloroquine, droperidol, pent- amidine; CYP3A4 inhibitors (amiodarone, clarithromycin, erythromycin, telithromy- cin, troleandomycin), arsenic trioxide; CYP3A4 substrates (methadone, pimo- zide, QUEtiapine, quiNIDine, risperiDONE, ziprasidone) Increase: hepatotoxicity—acetaminophen Increase: plasma concentrations of simvastatin, calcium channel blockers, warfarin; avoid use with warfarin, use low-molecular-weight anticoagulants instead Decrease: SUNItinib concentrations— dexamethasone, phenytoin, carBAMaze- pine, rifAMPin, PHENobarbital Drug/Herb Decrease: SUNItinib concentration—St. John’s wort Drug/Food Increase: plasma concentrations—grape- fruit juice NURSING CONSIDERATIONS
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DOSAGE AND ROUTES Gastrointestinal stromal tumors (GIST)/renal cell cancer • Adult: PO 50 mg/day × 4 wk, then 2 wk off; may increase or decrease dose by 12.5 mg; if administered with CYP3A4 inducers, give 87.5 mg/day; if given with CYP3A4 inhibitors, give 37.5 mg/day Pancreatic neuroendocrine (pNET) • Adult: PO 37.5 mg daily continuously, increase or decrease by 12.5 mg based on tolerance, avoid potent CYP3A4 inhibitors/ inducers; if used with CYP3A4 inhibitors, decrease SUNItinib dose to minimum of 25 mg/day; if used with CYP3A4 inducers, increase SUNItinib to max 62.5 mg/day
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Available forms: Caps 12.5, 25, 37.5, 50 mg
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Administer: • With meal and large glass of water to decrease GI symptoms • Store at 25°C (77°F)
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Assess: • ANC and platelets; if ANC <1 × 109/L and/or platelets <50 × 109/L, stop until ANC >1.5 × 109/L and platelets >75 × 109/L; if ANC <0.5 × 109/L and/or platelets <10 × 109/L, reduce dosage by 200 mg; if cytopenia continues, reduce dosage by another 100 mg; if cytopenia continues for 4 wk, stop product until ANC ≥1 × 109/L • CV status: hypertension, QT prolonga- tion can occur; monitor left ventricular ejection fraction (LVEF), MUGA at baseline, periodically; ECG • Renal toxicity: if bilirubin >3 × IULN, withhold SUNItinib until bilirubin levels return to <1.5 × IULN; electrolytes
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Evaluate: • Therapeutic response: decrease in size of tumor
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Patient and caregiver information: • To report adverse reactions immedi- ately: SOB, bleeding • About reason for treatment, expected result • That many adverse reactions may oc- cur: high B/P, bleeding, mouth swelling, taste change, skin discoloration, depig- mentation of hair/skin • To avoid persons with known upper respiratory infections; that immunosup- pression is common • To avoid grapefruit juice • To report if pregnancy is planned or suspected or if breastfeeding HIGH ALERT
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PHARMACOKINETICS Protein binding 95%; metabolized by CYP3A4; excreted in feces, small amount in urine; peak levels 6-12 hr; half-life 40-60 hr (SUNItinib); active metabolite 80-110 hr
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• Adult: PO 50 mg/day × 4 wk, then 2 wk off; may increase or decrease dose by 12.5 mg; if administered with CYP3A4 inducers, give 87.5 mg/day; if given with CYP3A4 inhibitors, give 37.5 mg/day Pancreatic neuroendocrine (pNET)
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• Adult: PO 37.5 mg daily continuously, increase or decrease by 12.5 mg based on tolerance, avoid potent CYP3A4 inhibitors/ inducers; if used with CYP3A4 inhibitors, decrease SUNItinib dose to minimum of 25 mg/day; if used with CYP3A4 inducers, increase SUNItinib to max 62.5 mg/day
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