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Voranigo · 4.5 · No clinically significant differences in vorasidenib pharmacokinetics were observed following co-administratio
Eintrag öffnenVoranigo · 4.5 · Sensitive substrates of CYP enzymes without narrow therapeutic index
Eintrag öffnenVoranigo · 4.5 · Strong CYP1A2 inhibitors
Eintrag öffnenVoranigo · 4.5 · Vorasidenib may decrease concentrations of hormonal contraceptives and, therefore, concomitant use of a barrie
Eintrag öffnenVoranigo · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenVoranigo · 4.8 Undesirable effects · 1
Eintrag öffnenVoranigo · 4.8 · 9 Reporting of suspected adverse reactions
Eintrag öffnenVoranigo · 4.8 · Blood and lymphatic system Very common Platelet count decreaseda disorders Hyperglycaemia Metabolism and nutri
Eintrag öffnenVoranigo · 4.8 · Description of selected adverse reactions
Eintrag öffnenVoranigo · 4.8 · Dose interruptions due to an adverse reaction occurred in 18.6% of patients treated with vorasidenib. The most
Eintrag öffnenVoranigo · 4.8 · Dose reductions of vorasidenib due to an adverse reaction occurred in 9.6% of patients. The most common advers
Eintrag öffnenVoranigo · 4.8 · Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100),
Eintrag öffnenVoranigo · 4.8 · Hepatotoxicity
Eintrag öffnenVoranigo · 4.8 · In the INDIGO study, of the 167 patients treated with vorasidenib, 18.6% experienced elevations in ALT > 3 tim
Eintrag öffnenVoranigo · 4.8 · Permanent discontinuation of vorasidenib due to grade ≥ 3 ALT increased or autoimmune hepatitis was reported i
Eintrag öffnenVoranigo · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenVoranigo · 4.8 · Serious adverse reactions of hepatic failure, autoimmune hepatitis and ALT increased each occurred in 0.6% of
Eintrag öffnenVoranigo · 4.8 · Summary of safety profile
Eintrag öffnenVoranigo · 4.8 · System organ class Frequency Adverse reactions
Eintrag öffnenVoranigo · 4.8 · Table 3: Adverse drug reactions reported in patients treated with vorasidenib
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