Active ingredients: Sunitinib (as malate) 12.5, 25, 50 mg.
Package(a):
CAPSULES: 28 x 12.5 mg. Dosage(a):
1 x 50 mg x daily orally on a schedule of 4 weeks of treatment followed by 2 weeks off. May be taken with or without food. See prescribing information for full details. Prescribing Restrictions:
Package(b):
CAPSULES: 28 x 25 mg. Dosage(b):
1 x 50 mg x daily orally on a schedule of 4 weeks of treatment followed by 2 weeks off. May be taken with or without food. See prescribing information for full details. Prescribing Restrictions:
Package(c):
CAPSULES: 28 x 50 mg. Dosage(c):
1 x 50 mg x daily orally on a schedule of 4 weeks of treatment followed by 2 weeks off. May be taken with or without food. See prescribing information for full details. Prescribing Restrictions:
Indications:
Treatment of gastrointestinal stromal tumor after disease progression on, or intolerance to imatinib mesylate. Treatment of advanced renal cell carcinoma. Treatment of unresectable or metastatic, well differentiated pancreatic neuroendocrine tumors (pNET) with disease progression. Contra-Indications:
Hypersensitivity to sunitinib or to any of the excipients. Special Precautions:
In the presence of clinical manifestations of congestive heart failure (CHF), discontinuation is recommended. Patients who presented with cardiac events within 12 months prior to administration, such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic CHF, cerebrovascular accident or transient ischemic attack, or pulmonary embolism were excluded from clinical studies. It is unknown whether patients with these concomitant conditions may be at a higher risk of developing drug-related left ventricular dysfunction. Physicians are advised to weigh this risk against the potential benefits of the drug. These patients should be carefully monitored for clinical signs and symptoms of CHF during treatmnent. Baseline and periodic evaluations of LVEF should also be considered during treatment. In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered. Treatment has been shown to prolong the QT interval in a dose dependent manner, which may lead to an increased risk for ventricular arrhythmias including Torsade de Pointes. Torsade de Pointes has been observed in <0.1% of exposed patients. Should be used with caution in patients with a history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. During therapy, periodic monitoring with ontreatment electrocardiograms and electrolytes (magnesium, potassium) should be considered. Concomitant treatment with strong CYP3A4 inhibitors, which may increase sunitinib plasma concentrations, should be used with caution and dose reduction should be considered. Patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy. In cases of severe hypertension, temporary suspension of treatment is recommended until hypertension is controlled. Hemorrhagic events may occur suddenly, and in the case of pulmonary tumors may present as severe and life-threatening hemoptysis or pulmonary hemorrhage. Fatal pulmonary hemorrhage occurred in 2 patients treated on a clinical trial of patients with metastatic non-small cell lung cancer (NSCLC). Serious, sometimes fatal gastrointestinal complications including GI perforation have occurred rarely in patients with intra-abdominal malignancies. Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism should be treated as per standard medical practice prior to the start of treatment. All patients should be observed closely for signs and symptoms of hypothyroidism on treatment. Patients with signs or symptoms suggestive of hypothyroidism should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice. Physicians are advised to monitor for adrenal insufficiency in patients who experience stress such as surgery, trauma or severe infection. CBCs with platelet count and serum chemistries including phosphate should be performed at the beginning of each treatment cycle. Dose increase or reduction of 12.5 mg increments is recommended based on individual safety and tolerability. A dose reduction to a minimum of 37.5 mg daily should be considered if co-administered with a strong CYP3A4 inhibitor, and a dose increase to a maximum of 87.5 daily should be considered if co-administered with a CYP3A4 inducer. If dose is increased, the patient should be carefully monitored for toxicity. Patients may experience dizziness. Pregnancy and lactation: If the drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment. Side Effects:
The most common adverse reactions (>20%) in patients with GIST or MRCC are fatigue, asthenia, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, rash, hand-foot syndrome, skin discoloration, altered taste, anorexia, and bleeding. See prescribing information for full details. Drug Interactions:
CYP3A4 inhibitors and inducers. See prescribing information for full details.
