Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Fulvestrant Mylan

Fulvestrant Mylan 250 mg solution for injection in prefilled syringe · Abschnitt 4.8 · PDF-Seite 7–8

HOS-140290 · Präparat HOS-098490

7  Dry eye 15 (4.3) 0 3 (1.7) 0 Respiratory, thoracic and mediastinal disorders Common Epistaxis 25 (7.2) 0 4 (2.3) 0 Gastrointestinal disorders Very common Nausea 124 (35.9) 2 (0.6) 53 (30.8) 1 (0.6) g Stomatitis 104 (30.1) 3 (0.9) 24 (14.0) 0 Diarrhoea 94 (27.2) 0 35 (20.3) 2 (1.2) Vomiting 75 (21.7) 2 (0.6) 28 (16.3) 1 (0.6) Skin and subcutaneous tissue disorders Very common Alopecia 67 (19.4) NA 11 (6.4) NA h Rash 63 (18.3) 3 (0.9) 10 (5.8) 0 Common Dry skin 28 (8.1) 0 3 (1.7) 0 General disorders and administration site conditions Very common Fatigue 152 (44.1) 9 (2.6) 54 (31.4) 2 (1.2) Pyrexia 47 (13.6) 1 (0.3) 10 (5.8) 0 Common Asthenia 27 (7.8) 1 (0.3) 13 (7.6) 2 (1.2) Investigations Very common AST increased 40 (11.6) 11 (3.2) 13 (7.6) 4 (2.3) Common ALT increased 30 (8.7) 7 (2.0) 10 (5.8) 1 (0.6) ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients; NA=Not applicable a Preferred Terms (PTs) are listed according to MedDRA 17.1. b Infections includes all PTs that are part of the System Organ Class Infections and infestations. c Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased. d Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased. e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased. f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased. g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis. h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.

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