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. Co-administration w/ strong CYP3A4 inducers (eg, rifampin) Increase dose in 12.5 increments to a max of 87.5 mg (GIST & RCC), or 62.5 mg (pNET) daily. Co-administration w/ strong CYP3A4 inhibitors (eg, ketoconazole) Reduce dose in 12.5 decrements to a min of 37.5 mg (GIST & RCC), or 25 mg (pNET) daily.
May be taken with or without food.
Special Precautions
Skin discoloration, skin & hair depigmentation, & other dermatological effects may occur. Discontinue if signs/symptoms of Stevens-Johnson or erythema multiforme (eg, progressive skin rash often w/ blisters/mucosal lesions) are present; symptoms of pancreatitis are present; clinical manifestations of CHF are present; if necrotizing fasciitis, thrombotic microangiopathy including thrombocytopenic purpura & hemolytic uremic syndrome, & nephrotic syndrome develops. Hemorrhagic events including GI, resp, tumor, urinary tract, & brain; pulmonary. Not approved for use in patients w/ NSCLC. GI complications including GI perforation in patients w/ intra-abdominal malignancies. GI events (eg, nausea, diarrhea, stomatitis, dyspepsia & vomiting). Monitor liver function tests (ALT, AST, bilirubin levels) before initiation of treatment, during each cycle of treatment, & 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 preexisting cardiac disease, bradycardia, or electrolyte disturbances. Temporary suspension is recommended in patients w/ severe HTN that is not controlled & w/ seizures. May promote formation of aneurysms &/or artery dissections in patients w/ or w/o HTN; carefully consider in patients w/ risk factors eg, HTN or history of aneurysm. Closely observe for signs & symptoms of thyroid dysfunction. Cases of impaired wound healing during therapy; temporary interruption of therapy is recommended in patients undergoing major surgical procedures. Avoid invasive dental procedures in patients who have previously or are receiving IV bisphosphonates. Patients w/ high tumor burden prior to therapy is at risk of tumor lysis syndrome. Monitor for the development or worsening of proteinuria. Regularly check blood glucose levels in diabetic patients. May impair ability to drive or operate machinery. Advised to avoid becoming pregnant in women of childbearing potential while on therapy. Male & female fertility may be compromised. Pregnancy. Should not be used during lactation. Childn.
Adverse Reactions
Infections; thrombotic microangiopathy, anemia, thrombocytopenia, neutropenia, leukopenia, lymphophenia; hypersensitivity, angioedema; hyperthyroidism, hypothyroidism, thyroiditis; dehydration, hypoglycemia, tumor lysis syndrome, decreased appetite; insomnia, depression; cerebral hemorrhage, CVA, cerebral infarction, transient ischemic attack, posterior reversible encephalopathy syndrome, headache, dizziness, paresthesia, aguesia, dysgeusia; periorbital & eyelid edema, increased lacrimation; myocardial ischemia, MI, cardiac failure, cardiomyopathy, left ventricular failure, Torsade de pointes, congestive cardiac failure; anuerysms & artery dissections, tumor hemorrhage, HTN, DVT; pulmonary embolism, dyspnea, hemoptysis, pleural effusion, epistaxis, oropharyngeal pain; GI hemorrhage/perforation, pancreatitis, esophagitis, abdominal distension/pain, diarrhea, vomiting, nausea, GERD, dyspepsia, stomatitis, constipation, oral pain, glossodynia, gingival bleeding, dry mouth, flatulence; hepatic failure, cholecystitis; Stevens-Johnson syndrome, erythema multiforme, pyoderma gangrenosum, dermatitis exfoliative, skin reaction/lesion, rash, erythema, pruritus, skin exfoliation, palmar-plantar erythrodysaesthesia syndrome, blister, skin discolouration, hair color changes, alopecia, nail disorder, dry skin; fistula, rhabdomyolysis, jaw osteonecrosis, myopathy, arthralgia, myalgia, pain in extremity; renal failure, nephrotic syndrome, renal impairment, urinary tract hemorrhage, urinary tract hemorrhage, proteinuria, chromaturia; fatigue, mucosal inflammation, edema, pyrexia, chills, flu-like illness; decreased ejection fraction, Hb, platelet count, WBC, & wt; increased lipase, blood uric acid, amylase, blood thyroid stimulating hormone, & blood creatine phosphokinase.
Drug Interactions
May increase plasma conc w/ strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, itraconzaole, erythromycin, clarithromycin, grapefruit juice). May decrease plasma conc w/strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, phenobarb or St. John's wort).
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EX01 - sunitinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Sutent cap 12.5 mg
28's (P84,210.62/pack)
Sutent cap 25 mg
28's (P168,405.46/pack)
Sutent cap 50 mg
28's (P336,795.14/pack)
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