Cytobin-10/Cytobin-50 Adverse Reactions

The following undesirable effects have been observed and reported during treatment with epirubicin with the following frequencies: More than 10% of treated patients can expect to develop undesirable effects. The most common undesirable effects are myelosuppression, gastrointestinal side effects, anorexia, alopecia, infection. (See Table 2.)

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Description of selected adverse reactions: Neoplasms benign, malignant and unspecified (including cysts and polyps): Secondary acute myeloid leukaemia with or without a pre-leukaemic phase, in patients treated with epirubicin in combination with DNA-damaging antineoplastic agents.
These leukaemias have a short (1-3 years) latency.
Blood and lymphatic system disorders: High doses of epirubicin have been safely administered in a large number of untreated patients having various solid tumours and have caused adverse events which are not different from those seen at conventional doses with the exception of reversible severe neutropenia (<500 neutrophils/mm³ for <7 days) which occurred in the majority of patients. Only few patients required hospitalisation and supportive therapy for severe infectious complications at high doses.
Skin and subcutaneous tissue disorders: Alopecia, normally reversible, appears in 60-90% of treated cases; it is accompanied by lack of beard growth in males.
General disorders and administration site conditions: Mucositis may appear 5-10 days after the start of treatment, and usually involves stomatitis with areas of painful erosions, ulceration and bleeding, mainly along the side of the tongue and the sublingual mucosa.
Local pain and tissue necrosis (following accidental paravenous injection) may occur.
Intravesical administration: As only a small amount of active ingredient is reabsorbed after intravesical instillation, severe systemic adverse reactions as well as allergic reactions are rare. Commonly reported are local reactions like burning sensation and frequent voiding (pollakisuria). Occasional bacterial or chemical cystitis have been reported. These adverse reactions are mostly reversible.