Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Javlor

Javlor 25 mg/mL concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8–10

HOS-209979 · Präparat HOS-154415

8  Table 4 Adverse reactions observed in patients with transitional cell carcinoma of the urothelium treated with vinflunine System Organ Class Frequency Adverse Reactions Worst NCI Grade per patient (%) All grades Grade 3-4 Infections and infestations Common Neutropenic infection 2.4 2.4 Infections (viral, bacterial, 7.6 3.6 fungal) Uncommon Neutropenic sepsis 0.2 0.2 Neoplasm benign, Uncommon Tumour pain 0.2 0.2 malignant and unspecified Blood and lymphatic Very common Neutropenia 79.6 54.6 system disorders Leucopenia 84.5 45.2 Anaemia 92.8 17.3 Thrombocytopenia 53.5 4.9 Common Febrile neutropenia 6.7 6.7 Immune system disorders Common Hypersensitivity 1.3 0.2 Endocrine disorders Uncommon Syndrome of Inappropriate Antidiuretic Hormone 0.4 b 0.4 b Secretion (SIADH) a Metabolism and nutrition Very common Hyponatraemia 39.8 11.7 disorders Decreased appetite 34.2 2.7 Common Dehydration 4.4 2.0 Psychiatric disorders Common Insomnia 5.1 0.2 Nervous system disorders Very common Peripheral sensory 11.3 0.9 neuropathy Common Syncope 1.1 1.1 Headache 6.2 0.7 Dizziness 5.3 0.4 Neuralgia 4.4 0.4 Dysgeusia 3.3 0 Neuropathy 1.3 0 Uncommon Peripheral motor neuropathy 0.4 0 Rare Posterior Reversible 0.03b 0.03b Encephalopathy Syndromea Eye disorders Uncommon Visual disturbance 0.4 0 Ear and Labyrinth Common Ear pain 1.1 0 disorders Uncommon Vertigo 0.9 0.4 Tinnitus 0.9 0 Cardiac disorders Common Tachycardia 1.8 0.2 Uncommon Myocardial ischaemia 0.7 0.7 Myocardial infarction 0.2 0.2 Vascular disorders Common Hypertension 3.1 1.6 Venous thrombosisc 3.6 0.4 Phlebitis 2.4 0 Hypotension 1.1 0.2 Respiratory, thoracic and Common Dyspnoea 4.2 0.4 mediastinal disorders Cough 2.2 0 Uncommon Acute respiratory distress 0.2 0.2 syndrome Pharyngolaryngeal pain 0.9 0 Gastrointestinal disorders Very common Constipation 54.9 15.1 Abdominal pain 21.6 4.7 9  Vomiting 27.3 2.9 Nausea 40.9 2.9 Stomatitis 27.1 2.7 Diarrhoea 12.9 0.9 Common Ileus 2.7 2.2 Dysphagia 2.0 0.4 Buccal disorders 4.0 0.2 Dyspepsia 5.1 0.2 Uncommon Odynophagia 0.4 0.2 Gastric disorders 0.8 0 Oesophagitis 0.4 0.2 Gingival disorders 0.7 0 Skin and subcutaneous Very common Alopecia 28.9 NA tissue disorders Common Rash 1.8 0 Urticaria 1.1 0 Pruritus 1.1 0 Hyperhidrosis 1.1 0 Uncommon Dry skin 0.9 0 Erythema 0.4 0 Musculoskeletal and Very common Myalgia 16.7 3.1 connective tissue Common Muscular weakness 1.8 0.7 disorders Arthralgia 7.1 0.4 Back pain 4.9 0.4 Pain in jaw 5.6 0 Pain in extremity 2.4 0 Bone pain 2.9 0 Musculoskeletal pain 2.7 0.2 Renal and urinary Uncommon Renal failure 0.2 0.2 disorders General disorders and Very common Asthenia/Fatigue 55.3 15.8 administration site Injection site reaction 26.4 0.4 conditions Pyrexia 11.7 0.4 Common Chest pain 4.7 0.9 Chills 2.2 0.2 Pain 3.1 0.2 Oedema 1.1 0 Uncommon Extravasation 0.7 0 Investigations Very common Weight decreased 24.0 0.4 Uncommon Transaminases increased 0.4 0 Weight increased 0.2 0 a adverse reactions reported from post-marketing experience b frequency calculated on the basis of non-TCCU clinical trial c include: phlebitis (2.4%), deep vein thrombosis (0.4%), superficial phlebitis (0.2%), thrombophlebitis (0.2%) and superficial thrombophlebitis (0.2%)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.