Nebenwirkungen · Teysuno
Teysuno 15 mg/4.35 mg/11.8 mg hard capsules · Abschnitt 4.8 · PDF-Seite 18
HOS-123746 · Präparat HOS-095721
Comparison of safety between 71 patients ≥70 years old (elderly) and 450 patients <70 years old treated with Teysuno in combination with cisplatin in the FLAGS study demonstrated that the incidence of all Grade 3 or higher adverse reactions (62% vs 52%), all serious adverse reactions (30% vs 19%), and the rate of premature withdrawal due to adverse reactions from both Teysuno and cisplatin (21% vs 12%) appeared to be higher among patients ≥70 years old. A population pharmacokinetics analysis demonstrated that 5-FU exposure also tended to increase with age, but the extent of the increase was within the range of individual variability. These changes with age were related to changes in renal function as measured by creatinine clearance (see section 5.2).
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