Pharmorubicin CS

Pharmorubicin CS Adverse Reactions





Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Dose limiting toxicities are myelosuppression and cardiotoxicity (see Precautions).
Drug-related adverse events that occurred during clinical trials are listed as follows: More Common Reactions (>5%): Blood and lymphatic system disorders: Myelosuppression, leukopaenia, neutropaenia, febrile neutropaenia, thrombocytopaenia, mild anaemia, secondary infection.
Cardiac disorders: Transient ECG changes, including low QRS voltage, tachycardia, arrhythmias, T wave flattening, ST depression and T inversion.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, mucositis (erythema, erosions/ulcerations, bleeding). Mucositis may appear 5-10 days after the start of treatment and usually involves stomatitis with areas of painful erosions, mainly along the sides of the tongue and on the sublingual mucosa.
Skin and subcutaneous tissue disorders: Alopecia, including the interruption of beard growth, usually reversible, occurs in 60%-90% of treated cases.
General disorders and administration site conditions: Erythematous streaking along the infused vein.
Metabolism and nutrition disorders: Dehydration.
Less Common Reactions (<5%): Blood and lymphatic system disorders: Severe thrombocytopaenia, anaemia, severe myelosuppression, pancytopaenia, sepsis, septicaemia, septic shock, tissue hypoxia, haemorrhage and death.
Cardiac disorders: Cardiomyopathy, congestive heart failure, cardiomegaly, atrioventricular and bundle branch block, tachyarrhythmias (premature ventricular contractions, ventricular tachycardia, bradycardia).
Gastrointestinal disorders: Oesophagitis, bleeding, hyperpigmentation of oral mucosa and abdominal pain or burning sensation.
Skin and subcutaneous tissue disorders: Local toxicity, rash/itch, transient urticaria, erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity of irradiated skin.
General disorders and administration site conditions: Chills, fever, malaise/asthenia, vesication, local pain, severe cellulitis and skin necrosis following perivenous drug extravasation.
Eye disorders: Conjunctivitis, keratitis.
Immune system disorders: Anaphylaxis.
Investigations: Asymptomatic drops in left ventricular ejection fraction, changes in transaminase levels.
Nervous system disorders: Weakness, dizziness, confusion, depression, paraesthesia.
Metabolism and nutrition disorders: Hyperuricaemia, anorexia.
Neoplasms benign and malignant: Acute lymphocytic leukaemia, acute myelogenous leukaemia.
Reproductive system disorders: Amenorrhoea, azoospermia.
Vascular disorders: Hot flushes, shock, thromboembolism, arterial embolism, thrombophlebitis, phlebitis, venous sclerosis.
Post-marketing Experience: Infections and infestations: Pneumonia.
Renal and urinary disorders: Red colouration of urine for 1 to 2 days after administration.
Respiratory, thoracic and mediastinal disorders: Pulmonary embolism.
Injury, poisoning and procedural complications: Chemical cystitis, sometimes haemorrhagic, and bladder constriction (following intravesical administration). Dose reduction (40%) may be necessary in these cases.
Reporting Suspected Adverse Effects: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
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