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Lojuxta · 4.5 · The effect of administration of more than one weak CYP3A4 inhibitor has not been tested, but the effect on the
Eintrag öffnenLojuxta · 4.5 · Weak CYP3A4 inhibitors are When administered with atorvastatin, the expected to increase the exposure of dose
Eintrag öffnenLojuxta · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenLojuxta · 4.8 Undesirable effects · 1
Eintrag öffnenLojuxta · 4.8 · 13 Table 4 lists all adverse reactions reported across the adult and paediatric HoFH patients treated in clini
Eintrag öffnenLojuxta · 4.8 · 14 System organ class Frequency Adverse reaction Investigations Very common Weight decreased Common Internatio
Eintrag öffnenLojuxta · 4.8 · 15 System organ class Frequency Adverse reaction Gastrointestinal disorders Very common Diarrhoea Nausea Flatu
Eintrag öffnenLojuxta · 4.8 · 16 Paediatric population
Eintrag öffnenLojuxta · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenLojuxta · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenLojuxta · 4.8 · Summary of the safety profile
Eintrag öffnenLojuxta · 4.8 · Table 4: Frequency of adverse reactions in HoFH patients System organ class Frequency Adverse reaction Infecti
Eintrag öffnenLojuxta · 4.8 · Table 5 lists all adverse reactions from Phase 2 studies which evaluated patients with elevated LDL-C (not HoF
Eintrag öffnenLojuxta · 4.8 · Table 5: Frequency of adverse reactions in elevated LDL-C patients System organ class Frequency Adverse reacti
Eintrag öffnenLojuxta · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenLojuxta · 4.8 · The adverse reactions are listed below by MedDRA SOC (System Organ Class) and by frequency, most frequent reac
Eintrag öffnenLojuxta · 4.8 · The most common adverse reactions in adults are gastrointestinal effects (93%) i.e. diarrhoea (79%), nausea (6
Eintrag öffnenLojuxta · 4.8 · The most commonly reported adverse reactions of severe intensity were diarrhoea (14%), vomiting (10%), abdomin
Eintrag öffnenLojuxta · 4.8 · The most serious adverse reactions during treatment were liver aminotransferase abnormalities (see section 4.4
Eintrag öffnenLojuxta · 4.8 · The safety and effectiveness of lomitapide have been established in paediatric patients with HoFH aged 5 to 17
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