Conduct baseline and periodic evaluation of LVEF in patients at risk of cardiac dysfunction, including previous anthracycline exposure. Monitor for clinical signs or symptoms of CHF. Monitor blood pressure (BP), and manage as appropriate.
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In a randomized RCC trial of VOTRIENT compared with sunitinib, myocardial dysfunction occurred in 13% of the 362 patients on VOTRIENT who had baseline and postbaseline LVEF measurements. In the randomized RCC trial (VEG105192), myocardial dysfunction was defined as symptoms of cardiac dysfunction or ≥15% absolute decline in LVEF compared with baseline or a decline in LVEF of ≥10% compared with baseline that is also below the lower limit of normal. In the RCC trials, cardiac dysfunction was observed in 0.6% of 586 patients without routine on-study LVEF monitoring. Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating VOTRIENT and during treatment.Ĭardiac Dysfunction: Cardiac dysfunction, such as congestive heart failure (CHF) and decreased left ventricular ejection fraction (LVEF), has occurred. Baseline and periodic monitoring of electrocardiograms and maintenance of electrolytes (eg, calcium, magnesium, potassium) within the normal range should be performed. Use with caution in patients with a history of QT interval prolongation, patients taking antiarrhythmics or other medications that may prolong QT interval, and those with relevant preexisting cardiac disease. QT Prolongation and Torsades de Pointes: Prolonged QT intervals and arrhythmias, including torsades de pointes, have occurred. Before the initiation of treatment and regularly during treatment, monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. Concomitant use of VOTRIENT and simvastatin increases the risk of ALT elevations and should be undertaken with caution. Treatment with VOTRIENT is not recommended in patients with severe hepatic impairment. In patients with preexisting moderate hepatic impairment, the starting dose of VOTRIENT should be reduced to 200 mg per day or alternatives to VOTRIENT should be considered.
Mild, indirect (unconjugated) hyperbilirubinemia may occur in patients with Gilbert’s syndrome. Transaminase elevations occur early in the course of treatment (92.5% of all transaminase elevations of any grade occurred in the first 18 weeks). Increases in serum transaminase levels (alanine aminotransferase, aspartate aminotransferase ) and bilirubin were observed. Patients older than 65 years are at an increased risk. Hepatic Toxicity: Severe and fatal hepatotoxicity has occurred.
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