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Rhapsido · 4.5 · Remibrutinib is primarily metabolised by CYP3A4.
Eintrag öffnenRhapsido · 4.5 · Transport substrates/inhibitors It is recommended to monitor patients more frequently for potential adverse re
Eintrag öffnenRhapsido · 4.5 · Vaccination immune response study In a placebo-controlled study in healthy volunteers using remibrutinib 100 m
Eintrag öffnenRhapsido · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenRhapsido · 4.8 Undesirable effects · 1
Eintrag öffnenRhapsido · 4.8 · 6 Table 1 Adverse reactions*
Eintrag öffnenRhapsido · 4.8 · Adverse reactions are listed according to MedDRA system organ class. Within each system organ class, the adver
Eintrag öffnenRhapsido · 4.8 · Description of selected adverse reactions
Eintrag öffnenRhapsido · 4.8 · In patients treated with remibrutinib, 0.5% experienced mucocutaneous bleeding events that led to remibrutinib
Eintrag öffnenRhapsido · 4.8 · Mucocutaneous bleeding events In the 24-week placebo-controlled, double-blind treatment period of the pooled d
Eintrag öffnenRhapsido · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenRhapsido · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenRhapsido · 4.8 · Summary of the safety profile
Eintrag öffnenRhapsido · 4.8 · System organ class Adverse reaction Frequency Upper respiratory tract infections1 Very common Infections and i
Eintrag öffnenRhapsido · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenRhapsido · 4.8 · The most frequently reported adverse reaction is upper respiratory tract infections (14.7%) such as nasopharyn
Eintrag öffnenRhapsido · 4.8 · The safety profile of remibrutinib in patients treated for up to 52 weeks in REMIX-1 and REMIX-2 remained cons
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