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Torisel · 4.5 · Interaction studies have only been performed in adults.
Eintrag öffnenTorisel · 4.5 · Interaction with medicinal products metabolised by CYP2D6 or CYP3A4/5
Eintrag öffnenTorisel · 4.5 · Interactions with medicinal products that are P-glycoprotein substrates
Eintrag öffnenTorisel · 4.5 · Temsirolimus has been associated with phospholipidosis in rats. Phospholipidosis has not been observed in mice
Eintrag öffnenTorisel · 4.5 · The combination of temsirolimus and sunitinib resulted in dose-limiting toxicity. Dose-limiting toxicities (Gr
Eintrag öffnenTorisel · 4.5 · The effect of a 175 or 75 mg temsirolimus dose on CYP3A4/5 substrates has not been studied. However, in vitro
Eintrag öffnenTorisel · 4.5 · There have been reports of increased blood levels of other mTOR inhibitors during concomitant use with cannabi
Eintrag öffnenTorisel · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenTorisel · 4.8 Undesirable effects · 1
Eintrag öffnenTorisel · 4.8 · 12 Table 1: Adverse reactions from clinical trials in RCC (study 3066K1-304) and in MCL (study 3066K1-305)
Eintrag öffnenTorisel · 4.8 · 13 System Frequency Adverse reactions All grades Grade organ class n (%) 3&4 n (%) Nervous system Very common
Eintrag öffnenTorisel · 4.8 · 14 System Frequency Adverse reactions All grades Grade organ class n (%) 3&4 n (%) Skin and Very common Rash (
Eintrag öffnenTorisel · 4.8 · 15 Adverse reactions that were reported in post-marketing experience are listed below (Table 2).
Eintrag öffnenTorisel · 4.8 · Adverse reactions that were reported in RCC and MCL patients in the phase 3 studies are listed below (Table 1)
Eintrag öffnenTorisel · 4.8 · Based on the results of the phase 3 studies, elderly patients may be more likely to experience certain adverse
Eintrag öffnenTorisel · 4.8 · Cases of PCP, some with fatal outcomes, have been reported (see section 4.4).
Eintrag öffnenTorisel · 4.8 · Cataracts have been observed in some patients who received the combination of temsirolimus and IFN-α.
Eintrag öffnenTorisel · 4.8 · Description of selected adverse reactions
Eintrag öffnenTorisel · 4.8 · In a Phase 1/2 study, 71 patients (59 patients, aged from 1 to 17 years old, and 12 patients, aged 18 to 21 ye
Eintrag öffnenTorisel · 4.8 · Paediatric population
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