Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Vimpat

Vimpat 10 mg/ml solution for infusion · Abschnitt 4.8 · PDF-Seite 74

HOS-119563 · Präparat HOS-094947

The use of lacosamide is associated with dose-related increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur. In adjunctive clinical studies in epilepsy patients the incidence rate of reported first-degree AV Block is uncommon, 0.7 %, 0 %, 0.5 % and 0 % for lacosamide 200 mg, 400 mg, 600 mg or placebo, respectively. No second- or higher degree AV Block was seen in these studies. However, cases with second- and third-degree AV Block associated with lacosamide treatment have been reported in post- marketing experience. In the monotherapy clinical study comparing lacosamide to carbamazepine CR the extent of increase in PR interval was comparable between lacosamide and carbamazepine. The incidence rate for syncope reported in pooled adjunctive therapy clinical studies is uncommon and did not differ between lacosamide (n=944) treated epilepsy patients (0.1 %) and placebo (n=364) treated epilepsy patients (0.3 %). In the monotherapy clinical study comparing lacosamide to carbamazepine CR, syncope was reported in 7/444 (1.6 %) lacosamide patients and in 1/442 (0.2 %) carbamazepine CR patients. Atrial fibrillation or flutter were not reported in short term clinical studies; however, both have been reported in open-label epilepsy studies and in post-marketing experience.

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