Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Prevymis

PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 15

HOS-139826 · Präparat HOS-098408

When letermovir is co-administered with cyclosporine, dabigatran is contraindicated. Sedatives midazolam ↑ midazolam Close clinical monitoring for respiratory (1 mg single dose Intravenous: depression and/or prolonged sedation intravenous)/ AUC 1.47 (1.37, 1.58) should be exercised during co- letermovir (240 mg Cmax 1.05 (0.94, 1.17) administration of letermovir with once daily PO) midazolam. Dose adjustment of PO: midazolam should be considered#. The midazolam (2 mg AUC 2.25 (2.04, 2.48) increase in midazolam plasma single dose PO) / Cmax 1.72 (1.55, 1.92) concentration may be greater when oral letermovir (240 mg midazolam is administered with letermovir once daily PO) (CYP3A inhibition) at the clinical dose than with the dose studied. Opioid agonists Examples: alfentanil, Interaction not studied. Frequent monitoring for adverse reactions fentanyl Expected: related to these medicinal products is ↑ CYP3A metabolised opioids recommended during co-administration. Dose adjustment of CYP3A metabolised (CYP3A inhibition) opioids may be needed# (see section 4.4). Monitoring is also recommended if changing route of administration. When letermovir is co-administered with cyclosporine, the magnitude of the increase in plasma concentrations of CYP3A metabolised opioids may be greater. Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during co- administration of letermovir in combination with cyclosporine and alfentanil or fentanyl. Refer to the

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): alfentanil (HOS-109375) dabigatran (HOS-112096) fentanyl (HOS-086196) cyclosporine (HOS-084512) midazolam (HOS-086167)