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Dacogen
Eintrag öffnenDacogen · 4.1 Therapeutic indications · 1
Eintrag öffnenDacogen · 4.3 Contraindications · 1
Eintrag öffnenDacogen · 4.3 · Breast-feeding (see section 4.6)
Eintrag öffnenDacogen · 4.3 · Hypersensitivity to decitabine or to any of the excipients, listed in section 6.1.
Eintrag öffnenDacogen · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenDacogen · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenDacogen · 4.5 · 4 Impact of co-administered medicinal products on decitabine Cytochrome (CYP) 450-mediated metabolic interacti
Eintrag öffnenDacogen · 4.5 · Impact of decitabine on co-administered medicinal products Given its low in vitro plasma protein binding ( 1%
Eintrag öffnenDacogen · 4.5 · No formal clinical drug interaction studies with decitabine have been conducted. There is the potential for a
Eintrag öffnenDacogen · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenDacogen · 4.8 Undesirable effects · 1
Eintrag öffnenDacogen · 4.8 · 5 In clinical studies, 30% of patients treated with Dacogen and 25% of patients treated in the comparator arm
Eintrag öffnenDacogen · 4.8 · 6 Not known enterocolitis, including Not known Not known neutropaenic colitis, caecitis* Hepatobiliary Very co
Eintrag öffnenDacogen · 4.8 · 7 Differentiation syndrome Cases of differentiation syndrome (also known as retinoic acid syndrome) have been
Eintrag öffnenDacogen · 4.8 · Description of selected adverse drug reactions
Eintrag öffnenDacogen · 4.8 · Gastrointestinal disorders Occurrences of enterocolitis, including neutropaenic colitis, caecitis have been re
Eintrag öffnenDacogen · 4.8 · Haematologic adverse drug reactions The most commonly reported haematologic adverse drug reactions associated
Eintrag öffnenDacogen · 4.8 · Haematological adverse drug reactions should be managed by routine monitoring of complete blood counts and ear
Eintrag öffnenDacogen · 4.8 · In the Dacogen treatment group, there was a higher incidence of treatment discontinuation due to adverse event
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