Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Fintepla

Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 12

HOS-132991 · Präparat HOS-097342

Lethargy, somnolence, and fatigue (grouping of fatigue/asthenia/malaise/decreased activity) In the controlled trials in subjects with Dravet syndrome, lethargy was commonly reported in 9.7%, and somnolence and fatigue were very commonly reported in 13.9% and 19%, respectively in the fenfluramine treatment groups combined. In the controlled study with Lennox-Gastaut syndrome, lethargy was commonly reported in 4.5% of subjects in the fenfluramine treatment group. Fatigue and somnolence were very commonly reported in 16.2% and 16.2% of subjects, respectively. The majority of the adverse reactions of lethargy, somnolence, and fatigue/asthenia were reported in the first 2 weeks of treatment with fenfluramine and were mild or moderate in severity. Discontinuation due to lethargy, somnolence, and fatigue/asthenia was rare and, in most cases, these adverse reactions resolved or improved with ongoing treatment. In the controlled trials with Dravet syndrome, 0.5% and 1.4% of subjects in the fenfluramine treatment groups combined discontinued due to lethargy and somnolence, respectively. In the LGS study 4, 1.5% of subjects in the fenfluramine treatment group discontinued due to somnolence.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.