Sutent Disease Interactions

The use of sunitinib has been associated with hepatotoxicity, including hepatic failure and in some cases with fatal outcomes. Patients with hepatic impairment (total bilirubin > upper limit of normal (ULN) or Child-Pugh A, B and C) should be closely monitored during therapy with sunitinib. Safety in patients with ALT or AST >2.5 × ULN or, if due to liver metastases, >5.0 × ULN has not been established. Clinical monitoring of hepatic function (transaminases, bilirubin, and alkaline phosphatase) is recommended during treatment and increase frequency of monitoring is required for patients with preexisting or existing hepatic impairment. Obtain periodic liver function testing and withhold for Grade 3 or 4 drug-related hepatic adverse events. Discontinued if symptoms of pancreatitis or hepatic failure are present. Do not restart sunitinib if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure.

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The use of certain multikinase inhibitors has been associated with pulmonary toxicity. Serious cases of interstitial lung disease (ILD), including fatal cases and interstitial pneumonitis or pulmonary fibrosis have been reported. Caution is recommended when using these agents in patients with a history of interstitial pneumonitis or pulmonary fibrosis or those patients presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, these agents should be permanently discontinued and appropriate measures should be instituted. Treatment should be immediately withheld in patients diagnosed with ILD/pneumonitis and permanently discontinued if no other potential causes of ILD/pneumonitis have been identified.

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Caution should be exercised when prescribing sunitinib in patients that elicit a stress response due to the hormonal and metabolic changes resulting from an injury, trauma, or a severe infection.

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The use of sunitinib has been associated with adverse cardiovascular events, including heart failure, cardiomyopathy, myocardial ischemia, and myocardial infarction, some of which were fatal. Because of these risks, physicians are advised to weigh this risk against the potential benefits of the drug when prescribing this drug to patients with cardiovascular dysfunction. These patients should be carefully monitored and baseline and periodic evaluations of cardiovascular function should be considered while these patients are receiving sunitinib, especial caution is recommended in patients who are at risk for, or who have a history of cardiovascular events. In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered.

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Cutaneous reactions, in some cases severe, have been reported with the use of sunitinib. Monitor patients who develop dermatologic or soft tissue toxicities while receiving this agent. It is recommended to withhold treatment, and appropriate measures should be instituted as appropriate or discontinue the use of this agent for dermatologic or soft tissue toxicity associated with severe or life-threatening complications. If a diagnosis of Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected treatment with sunitinib must not be re-started.

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The use of sunitinib has been associated with hemorrhagic events, some of which have been fatal. Caution should be exercised in patients with or predisposed to bleeding complications. Clinical assessment of these patients should include serial complete blood counts and physical examinations.

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The use of sunitinib has been associated with hypertension and it should be used with caution in patients with elevated blood pressure. Therapy with sunitinib should be withheld in case of severe hypertension and appropriate measures should be taken to correct the blood pressure to acceptable readings. Close monitoring of blood pressure is recommended.

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The use of sunitinib has been associated with symptomatic hypoglycemia, resulting in loss of consciousness or hospitalization. Patients with diabetes mellitus should be monitored more closely during and after discontinuation of treatment with sunitinib, and their antidiabetic regimen should be adjusted accordingly.

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Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking sunitinib. Patients with risk factors, such as those taking bisphosphonate medications or that have a dental disease could be at an increased risk of developing ONJ. Close monitoring should be exercise when prescribing sunitinib to these patients.

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Therapy with sunitinib should be administered cautiously in patients with renal dysfunction. Monitoring for proteinuria and hematuria is recommended and perform baseline and periodic urinalyses during treatment, with follow up measurement as clinically indicated. Patients with nephrotic syndrome or repeat episodes of urine protein >=3 grams despite dose reductions should be instructed to withhold the dose of sunitinib and take appropriate actions according to clinical standards.

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Sunitinib can cause QT prolongation in a dose-dependent manner, which may lead to an increased risk for ventricular arrhythmias, including Torsade de Pointes. This agent should be administered with caution in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Serum electrolytes should be corrected before initiating therapy with this agent. Periodic monitoring of ECGs and electrolytes is recommended in these patients.

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Thyroid abnormalities, hypothyroidism or hyperthyroidism, have been reported in patients taking sunitinib. Therapy with sunitinib should be administered cautiously to patients with thyroid dysfunction. Baseline laboratory measurement of thyroid function is recommended and if appropriate, treatment per standard medical practice should be given prior to initiation of therapy. Clinical monitoring of thyroid function is recommended during therapy.

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No dosage adjustment of sunitinib is necessary in patients with renal impairment. However, when sunitinib therapy was given to patients with end-stage renal disease (ESRD) or on hemodialysis, the systemic exposure was 47% lower in subjects with ESRD on hemodialysis compared to subjects with normal renal function. Therefore, the subsequent doses may be increased gradually up to 2 fold based on safety and tolerability.

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