Sutent

Sutent

sunitinib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Sunitinib malate
Indications/Uses
GI stromal tumor (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance; advanced &/or metastatic renal cell carcinoma (MRCC); unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) w/ disease progression. Adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.
Dosage/Direction for Use
GIST & MRCC Recommended dose: 50 mg once daily for 4 consecutive wk, followed by a 2-wk off period (schedule 4/2) to complete a 6-wk cycle. Dose modification: 12.5 mg increment or decrements may be applied based on individual safety & tolerability up to 75 mg or min to 25 mg. Adjuvant treatment of RCC Recommended dose: 50 mg once daily on schedule 4/2 for nine 6-wk cycles (approx 1 yr).  pNET Recommended dose: 37.5 mg once daily w/o scheduled rest period. Max dose in Phase 3 pNET study: 50 mg daily. Dose modification: 12.5 mg increments or decrements may be applied based on individual safety & tolerability. Co-administration w/ strong CYP3A4 inducers (eg, rifampin) May be increased in 12.5 mg increments to a max: 87.5 mg (GIST & RCC) or 62.5 mg (pNET) daily. Co-administration w/ strong CYP3A4 inhibitors (eg, ketoconazole) May be reduced to 12.5 mg decrements to min of 37.5 mg (GIST & RCC) or 25 mg (pNET) daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Depigmentation of hair or skin may occur during treatment. Discontinue if SJS or erythema multiforme (eg, progressive skin rash often w/ blisters or mucosal lesions); pancreatitis; necrotizing fasciitis, thrombotic microangiopathy, nephrotic syndrome, & CHF occur. Not for patients w/ NSCLC. Routine assessment for treatment-emergent bleeding events should include CBC & physical exam. Patients w/ intra-abdominal malignancies. Supportive care for GI adverse events requiring treatment may include anti-emetic or anti-diarrheal medication. Monitor LFTs (ALT, AST, bilirubin levels) before initiation of treatment, during each cycle of treatment, & as clinically indicated; monitor patients at risk of tumor lysis syndrome w/ high tumor burden, & regularly check blood glucose levels in diabetics. Interrupt treatment for Grade 3 or 4 hepatic-related adverse events & discontinue if there is no resolution. Perform CBC at the start of each treatment cycle. Patients who are at risk for or who have history of CV events eg, heart failure, cardiomyopathy, myocardial ischemia & MI. Carefully monitor for clinical signs & symptoms of CHF; development or worsening of proteinuria. Consider baseline & periodic LVEF evaluations; baseline evaluation of ejection fraction in patients w/o cardiac risk factors. Patients w/ known history of QT interval prolongation, taking antiarrhythmics, or w/ relevant preexisting cardiac disease, bradycardia or electrolyte disturbances. Concomitant treatment w/ strong CYP3A4 inhibitors; IV bisphosphonates. Screen patients for HTN & control as appropriate. Baseline laboratory measurement of thyroid function, & baseline urinalysis are recommended. Treat hypo- or hyperthyroidism, & signs & symptoms suggestive of thyroid dysfunction prior to start of therapy. Patients w/ seizures & signs/symptoms consistent w/ reversible posterior leukoencephalopathy syndrome (RPLS) eg, HTN, headache, decreased alertness, altered mental functioning & visual loss including cortical blindness. Temporarily interrupt therapy in patients undergoing major surgical procedures. Consider dental exam & appropriate preventive dentistry prior to treatment. Avoid invasive dental procedures. May affect ability to drive or operate machinery. Pregnancy & lactation. Ped patients.
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.
Drug Interactions
Increased plasma conc w/ strong CYP3A4 inhibitors (eg, ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice). Decreased 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.
Presentation/Packing
Form
Sutent cap 12.5 mg
Packing/Price
28's
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