Nebenwirkungen · Atriance
Atriance 5 mg/ml solution for infusion · Abschnitt 4.8 · PDF-Seite 5
HOS-208714 · Präparat HOS-154169
The safety profile from pivotal clinical studies at the recommended doses of nelarabine in adults (1,500 mg/m2) and children (650 mg/m2) is based on data from 103 adults and 84 paediatric patients respectively. The most frequently occurring adverse events were fatigue; gastrointestinal disorders; haematological disorders; respiratory disorders; nervous system disorders (somnolence, peripheral neurological disorders [sensory and motor], dizziness, hypoaesthesia, paraesthesia, headache); and pyrexia. Neurotoxicity is the dose-limiting toxicity associated with nelarabine therapy (see section 4.4).
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