Gemibine-200/Gemibine-1000 Adverse Reactions

The most commonly reported adverse drug reactions associated with Gemcitabine treatment include: nausea with or without vomiting, raised liver transaminases (AST/ALT) and alkaline phosphatase, reported in approximately 60% of patients; proteinuria and haematuria reported in approximately 50% patients; dyspnoea reported in 10-40% of patients (highest incidence in lung cancer patients); allergic skin rashes occur in approximately 25% of patients and are associated with itching in 10% of patients.
The frequency and severity of the adverse reactions are affected by the dose, infusion rate and intervals between doses. Dose-limiting adverse reactions are reductions in thrombocyte, leucocyte and granulocyte counts.
Clinical trial data: Frequencies are defined as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very Rare (<1/10,000).
The following table of undesirable effects and frequencies is based on data from clinical trials. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 4.)

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Postmarketing experience (spontaneous reports) frequency not known (can't be estimated from the available data): Nervous system disorders: Cerebrovascular accident.
Cardiac disorders: Arrhythmias, predominantly supraventricular in nature, Heart failure.
Vascular disorders: Clinical signs of peripheral vasculitis and gangrene.
Respiratory, thoracic and mediastinal disorders: Pulmonary oedema, Adult respiratory distress syndrome.
Gastrointestinal disorders: Ischaemic colitis.
Hepatobiliary disorders: Serious hepatotoxicity, including liver failure and death.
Skin and subcutaneous tissue disorders: Severe skin reactions, including desquamation and bullous skin eruptions, Lyell's Syndrome, Steven-Johnson Syndrome.
Renal and urinary disorders: Renal failure Haemolytic uraemic syndrome.
Injury, poisoning and procedural complications: Radiation recall.
Combination use in breast cancer: The frequency of grade 3 and 4 haematological toxicities, particularly neutropaenia, increases when gemcitabine is used in combination with paclitaxel. However, the increase in these adverse reactions is not associated with an increased incidence of infections or haemorrhagic events. Fatigue and febrile neutropaenia occur more frequently when gemcitabine is used in combination with paclitaxel. Fatigue, which is not associated with anaemia, usually resolves after the first cycle. (See Table 5.)

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Combination use in bladder cancer: (see Table 6).

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Combination use in ovarian cancer: (see Table 7).

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