Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Hycamtin

HYCAMTIN 1 mg powder for concentrate for solution for infusion HYCAMTIN 4 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6–7

HOS-086064 · Präparat HOS-083256

6  Immune system disorders Common Hypersensitivity reaction including rash Rare Anaphylactic reaction, angioedema, urticaria Metabolism and nutrition disorders Very common Anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare Interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common Nausea, vomiting and diarrhoea (all of which may be severe), constipation, abdominal pain2, mucositis Not known Gastrointestinal perforation Hepatobiliary disorders Common Hyperbilirubinaemia Skin and subcutaneous tissue disorders Very common Alopecia Common Pruritus General disorders and administration site conditions Very common Pyrexia, asthenia, fatigue Common Malaise Very rare Extravasation3 Not known Mucosal inflammation 1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4). 2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4). 3 Reactions have been mild and have not generally required specific therapy.

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