Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Velcade

VELCADE 3.5 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 50

HOS-112818 · Präparat HOS-093755

Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with VcR-CAP in a clinical trial System Organ Class Incidence Adverse reaction Infections and Very Common Pneumonia* infestations Common Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex* Uncommon Hepatitis B, Infection*, Bronchopneumonia Blood and Very Common Thrombocytopenia*, Febrile neutropenia, Neutropenia*, lymphatic system Leukopenia*, Anaemia*, Lymphopenia* disorders Uncommon Pancytopenia* Immune system Common Hypersensitivity* disorders Uncommon Anaphylactic reaction Metabolism and Very Common Decreased appetite nutrition disorders Common Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*, Diabetes mellitus*, Fluid retention Uncommon Tumour lysis syndrome Psychiatric Common Sleep disorders and disturbances* disorders Nervous system Very Common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* disorders Common Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance Eye disorders Common Vision abnormal* Ear and labyrinth Common Dysacusis (inc tinnitus)* disorders Uncommon Vertigo*, Hearing impaired (up to and inc deafness) Cardiac disorders Common Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction* Uncommon Cardiovascular disorder (inc cardiogenic shock) Vascular disorders Common Hypertension*, Hypotension*, Orthostatic hypotension Respiratory, Common Dyspnoea*, Cough*, Hiccups thoracic and Uncommon Acute respiratory distress syndrome, Pulmonary embolism, mediastinal Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc disorders acute) Gastrointestinal Very Common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, disorders Constipation Common Gastrointestinal haemorrhage (inc mucosal)*, Abdominal distension, Dyspepsia, Oropharyngeal pain*, Gastritis*, Oral ulceration*, Abdominal discomfort, Dysphagia, Gastrointestinal inflammation*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder* Uncommon Colitis (inc clostridium difficile)* Hepatobiliary Common Hepatotoxicity (inc liver disorder) disorders Uncommon Hepatic failure Skin and Very Common Hair disorder* subcutaneous Common Pruritus*, Dermatitis*, Rash* tissue disorders

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