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Eintrag öffnenRezdiffra · 4.1 Therapeutic indications · 1
Eintrag öffnenRezdiffra · 4.3 Contraindications · 1
Eintrag öffnenRezdiffra · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenRezdiffra · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenRezdiffra · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenRezdiffra · 4.5 · 4 Effects of resmetirom on other medicinal products
Eintrag öffnenRezdiffra · 4.5 · Although no dose adjustment is required, clinical monitoring is recommended when resmetirom is used with certa
Eintrag öffnenRezdiffra · 4.5 · CYP2C8 inhibitors Clopidogrel, a moderate CYP2C8 inhibitor, increased resmetirom exposure (1.3-fold in Cmax an
Eintrag öffnenRezdiffra · 4.5 · CYP2C8 substrates Resmetirom is a substrate and mild inhibitor of CYP2C8. In a clinical study in healthy subje
Eintrag öffnenRezdiffra · 4.5 · Effects of other medicinal products on resmetirom
Eintrag öffnenRezdiffra · 4.5 · HMG-CoA reductase inhibitors (statins) The effect of resmetirom on the pharmacokinetics of statins (i.e., simv
Eintrag öffnenRezdiffra · 4.5 · OATP1B1, OATP1B3 and BCRP inhibitors No clinically significant differences in the pharmacokinetics of resmetir
Eintrag öffnenRezdiffra · 4.5 · Resmetirom is partially metabolised by CYP2C8.
Eintrag öffnenRezdiffra · 4.5 · Warfarin In healthy subjects with stable INR, administration of resmetirom (100 mg/day) for multiple days had
Eintrag öffnenRezdiffra · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenRezdiffra · 4.8 Undesirable effects · 1
Eintrag öffnenRezdiffra · 4.8 · Adverse reactions are listed by MedDRA system organ class and frequency: very common (≥ 1/10); common (≥ 1/100
Eintrag öffnenRezdiffra · 4.8 · Description of selected adverse reactions
Eintrag öffnenRezdiffra · 4.8 · Diarrhoea typically occurred at treatment initiation, was mild to moderate and self-limiting, resolving on ave
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