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Zydelig · 4.5 · Effect of idelalisib on the pharmacokinetics of other medicinal products
Eintrag öffnenZydelig · 4.5 · For erectile dysfunction:
Eintrag öffnenZydelig · 4.5 · Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and glucuronidation
Eintrag öffnenZydelig · 4.5 · Interaction studies have only been performed in adults.
Eintrag öffnenZydelig · 4.5 · Medicinal product Expected effect of Clinical recommendation upon idelalisib on medicinal co-administration wi
Eintrag öffnenZydelig · 4.5 · Oral budesonide ↑ serum concentrations Clinical monitoring is recommended for increased signs/symptoms of cort
Eintrag öffnenZydelig · 4.5 · Paediatric population
Eintrag öffnenZydelig · 4.5 · Potential interactions between idelalisib and co-administered medicinal products that are CYP3A substrates are
Eintrag öffnenZydelig · 4.5 · Sildenafil ↑ serum concentrations Idelalisib should not be co-administered with sildenafil.
Eintrag öffnenZydelig · 4.5 · Sildenafil, tadalafil ↑ serum concentrations Particular caution must be used and dose reduction may be conside
Eintrag öffnenZydelig · 4.5 · Substrates of inducible enzymes (e.g., CYP2C9, CYP2C19, CYP2B6 and UGT) In vitro, idelalisib was an inducer of
Eintrag öffnenZydelig · 4.5 · Table 1: Interactions between idelalisib and other medicinal products that are CYP3A substrates
Eintrag öffnenZydelig · 4.5 · Tadalafil ↑ serum concentrations Caution should be exercised, including consideration of dose reduction, when
Eintrag öffnenZydelig · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenZydelig · 4.8 Undesirable effects · 1
Eintrag öffnenZydelig · 4.8 · 11 and 136 subjects who received idelalisib in combination with an anti-CD20 monoclonal antibody (rituximab or
Eintrag öffnenZydelig · 4.8 · 12 Description of selected adverse reactions
Eintrag öffnenZydelig · 4.8 · Assessment of adverse reactions is based on two Phase 3 studies (study 312-0116 and study 312-0119) and six Ph
Eintrag öffnenZydelig · 4.8 · In clinical studies of subjects with hematologic malignancies who received idelalisib, the most frequently rep
Eintrag öffnenZydelig · 4.8 · Infections (see section 4.4) Higher frequencies of infections overall, including Grade 3 and 4 infections, wer
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