Anaphylactic reaction
Hypersensitivity
Metabolism and nutrition disorders
Weight decreased
Tumour lysis syndrome
Hyperglycaemia
Protein total decreased
Anorexia
Psychiatric disorders
Anxiety
Nervous system disorders
Syncope
Dizziness
Tremor
Paraesthesia
Hypoesthesia
Headache
Vertigo
Eye disorders
Conjunctivitis
Cardiac disorders
Cyanosis
Bradycardia
Tachycardia
Sinus tachycardia
Cardiac arrest
Myocardial infarction
Angina pectoris
Atrial fibrillation
Arrhythmia supraventricular
Sinus bradycardia
Supraventricular extrasystoles
Vascular disorders
Hypotension
Hypertension
Orthostatic hypotension
Hot flush
Flushing
Respiratory, thoracic and mediastinal disorders
Bronchospasm
Dyspnoea
Hypoxia
Pleural effusion
Dysphonia
Rhinorrhoea
Gastrointestinal disorders
Nausea
Vomiting
Abdominal pain
Ileus
Oral discomfort
Stomach discomfort
Diarrhoea
Skin and subcutaneous tissue disorders
Urticaria
Rash
Dermatitis allergic
Pruritus
Hyperhidrosis
Erythema
Rash pruritic
Rash macular
Rash erythematous
Dermatitis
Musculoskeletal and connective tissue disorders
Myalgia
Musculoskeletal pain
Back pain
Bone pain
Arthralgia
Musculoskeletal chest pain
Muscle spasms
Renal and urinary disorders
Urine output decreased
Dysuria
General disorders and administration site conditions
Fever
Chills
Fatigue
Asthenia
Mucosal inflammation
Infusion site erythema
Localised oedema
Infusion site oedema
Malaise
Acute infusion reactions including fever, chills, nausea, vomiting, hypotension, fatigue, rash, urticaria, dyspnoea, headache, pruritus and diarrhoea have been reported. The majority of these reactions are mild to moderate in severity. Acute infusion reactions usually occur during the first week of therapy and substantially decline thereafter. Grade 3 or 4 infusion reactions are uncommon after the first week of therapy.
Undesirable effects in previously treated patients
Safety data in previously treated B-CLL patients are based on 149 patients enrolled in single-arm studies of MabCampath (Studies 1, 2, and 3). More than 80% of previously treated patients may be expected to experience adverse reactions; the most commonly reported reactions usually occur during the first week of therapy.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System organ class
Very common
Common
Uncommon
Infections and infestations
Sepsis
Pneumonia
Herpes simplex
Cytomegalovirus infection
Pneumocystis jiroveci infection
Pneumonitis
Fungal infection
Candidiasis
Herpes zoster
Abscess
Urinary tract infection
Sinusitis
Bronchitis
Upper respiratory tract infection
Pharyngitis
Infection
Bacterial infection
Viral infection
Fungal dermatitis
Laryngitis
Rhinitis
Onychomycosis
Neoplasms, benign, malignant and unspecified (incl. cysts and polyps)
Lymphoma – like disorder
Blood and lymp |
