Wechselwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.5 · PDF-Seite 8–9
HOS-132971 · Präparat HOS-097342
Effect of rifampicin (a strong inducer of CYP3A and 2C19 and a moderate inducer of CYP1A2, 2B6, 2C8 and 2C9), or strong CYP1A2 or CYP2B6 inducers Rifampicin induces multiple CYP enzymes which metabolize fenfluramine and norfenfluramine. Coadministration of a single 0.35 mg/kg dose of fenfluramine with rifampicin at steady state (600 mg once daily) in healthy volunteers decreased the AUC 0-t of fenfluramine by 58% and the C max by 40%, and decreased the AUC 0-t of norfenfluramine by 50%, and increased the C max of norfenfluramine by 13%, as compared to fenfluramine administered alone. An increase in fenfluramine dose may be necessary when coadministered with rifampicin or a strong CYP1A2 or CYP2B6 inducer (see section 4.4). 8 Effect of CYP1A2 or CYP2D6 inhibitors Coadministration of a single 0.35 mg/kg dose of fenfluramine with fluvoxamine (a strong CYP1A2 inhibitor) at steady state (50 mg once daily) in healthy volunteers increased the AUC 0-t of fenfluramine by a ratio of 2.1-fold and the C max by a ratio of 1.2-fold, and decreased the AUC 0-t of norfenfluramine by a ratio of 1.3-fold and the C max by a ratio of 1.4-fold, as compared to fenfluramine administered alone.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): fluvoxamine (HOS-085908)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage a6e4654d866414c6dbc4eeafc18ee3dd0229294b181385fad59a9ce4ade2e263 · Zeichen 1688–2928 im Abschnitt