Abingem Adverse Reactions

The most commonly reported adverse reactions associated with gemcitabine treatment include: nausea, with or without vomiting, and raised liver transaminases (AST/ALT) and alkaline phosphatase, reported in approximately 60% of patients; proteinuria and haematuria reported in approximately 50% of patients; dyspnoea reported in 10-40% of patients (highest incidence in lung cancer patients); allergic skin rashes occurring 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 (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). (See Table 4.)

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Combination Use in Breast Cancer: The frequency of Grade 3 and 4 haematological toxicities, particularly neutropenia, 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.
Grade 3 and 4 Adverse Events, Paclitaxel Versus Gemcitabine plus Paclitaxel: (See Table 5.)

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Combination use in bladder cancer: Grade 3 and 4 Adverse Events, MVAC versus gemcitabine plus cisplatin: (See Table 6.)

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Combination use in ovarian cancer: Grade 3 and 4 Adverse Events, Carboplatin versus gemcitabine plus carboplatin: (See Table 7.)

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Sensory neuropathy was also more frequent in the combination arm that with single agent carboplatin.