Gemcitabine AqVida

Gemcitabine AqVida is indicated for:

• Cancer

Haematological Toxicity: Because Gemzar suppresses the bone marrow, anaemia, leukopenia and thrombocytopenia can occur after it is given. Myelosuppression is usually mild to moderate and affects the granulocyte count most. Two-thirds of patients experience some anaemia, yet only 7% have haemoglobin levels fall below 8 g/100 mL. Although 19% of patients received transfusions, only 0.2% of patients stopped treatment because of anaemia. The white blood cell count is lowered in 61% of patients, yet only 9% of patients have WBC's below 2000 cells/mm 3 and only 0.1% stopped treatment for leukopenia. Sixty-four percent of patients have reduced granulocyte counts, and almost 25% fall below 1000 cells/mm 3. Platelet counts are reduced in 21% of patients, though only 5% of patients have counts below 50,000 cells/mm 3 and only 0.4% of patients stopped treatment because of thrombocytopenia. Earlier treatment with cytotoxic agents appears to increase how often and how severely leukopenia, granulocytopenia and thrombocytopenia occur. There is no evidence that haematological toxicity builds up over time. Anaemia can be managed with conventional transfusions. The dose may need to be reduced or omitted for severe leukopenia or thrombocytopenia. Rare cases of haemorrhage occurring at the same time as thrombocytopenia have been reported, though these were usually thought to be related to the disease. Thrombocythemia is also commonly reported (7.5% of patients), though no patients stopped treatment for this event. Febrile neutropenia is also commonly reported. Hepatic Toxicity: Abnormal liver transaminase enzymes occur in about two-thirds of patients, though these are usually mild, do not progress, and rarely require stopping treatment. Fewer than 10% of patients have rises greater than 5 times normal, and only 0.5% of patients stopped treatment for abnormal liver function. One patient stopped treatment for liver failure, though the assessment was complicated by a history of chronic alcoholism. Effects on alanine transaminase (ALT) decline over time even when treatment continues. Rises in alkaline phosphatase greater than 5 times normal occurred in 6.6% of patients, though these may have been caused by bone disorders. Bilirubin values greater than 5 times normal were seen in 1.5% of patients, while ninety percent of patients had normal bilirubin levels. Gastrointestinal: Nausea, and nausea accompanied by vomiting, are each reported in about one-third of patients. This adverse event needs treatment in about 20% of patients, is rarely dose-limiting, and is easily managed with standard antiemetics. Only 0.9% of patients report intractable vomiting, and only 0.9% of patients stopped treatment because of nausea and vomiting. Diarrhoea and stomatitis are commonly reported. Diarrhoea (transient to tolerable) was reported by 7% of patients. Intolerable diarrhoea needing treatment was reported in 0.5% of patients. No patients stopped treatment because of diarrhoea. Genito-Urinary Toxicity: Mild proteinuria and haematuria are reported in about half of patients, though these are rarely clinically significant and are not usually linked with any change in serum creatinine or blood urea nitrogen. However, a few cases (0.6% of patients) of renal failure of uncertain cause have been reported, so Gemzar should be used with caution in patients with impaired renal function. Rare cases (0.4%) of possible haemolytic uraemic syndrome have been reported. Renal toxicity has not been seen to build up over time. Pulmonary Toxicity: Dyspnoea occurring within hours of a Gemzar injection is reported by about 10% of patients. This dyspnoea is usually mild and short-lived, rarely dose-limiting, and usually settles on its own without any specific treatment. The mechanism of this toxicity is unknown, and its relationship to Gemzar is not clear. Only 0.6% of patients stopped treatment because of dyspnoea, and only 0.1% of these were believed to be medicine-related. Interstitial pneumonitis has been reported infrequently. Allergic Toxicity: A rash is seen in about 25% of patients and comes with pruritus in about 10% of patients. The rash is usually mild, not dose-limiting, and responds to local treatment. Desquamation, vesiculation and ulceration have been reported rarely. Only 0.3% of patients stopped treatment for cutaneous toxicity. Gemzar is well tolerated during the infusion, with only a few cases of injection site reaction reported. Gemzar does not appear to be a vesicant. There have been no reports of injection site necrosis. Bronchospasm is usually mild and transient, though parenteral treatment may be needed. Gemzar should not be given to patients with a known hypersensitivity to the medicine. Neurotoxicity: Mild to moderate somnolence occurs in about 10% of patients. Only 0.1% of patients stopped treatment for somnolence. Asthenia is often reported together with other flu symptoms, and is also reported on its own. Asthenia led to stopping treatment in 1.4% of patients. Paresthesias are reported in 3.4% of patients, though only 0.2% report these as severe. Oedema/Peripheral Oedema: Oedema/peripheral oedema is reported by about 30% of patients. Some cases of facial oedema have also been reported. Pulmonary oedema was reported infrequently (1%). Oedema/peripheral oedema is usually mild to moderate, rarely dose-limiting, is sometimes reported as painful, and usually reverses after Gemzar treatment is stopped. The mechanism of this toxicity is unknown. However, it was not linked with any evidence of cardiac, renal or hepatic failure. Oedema led to stopping treatment in 0.7% of patients. Alopecia: Overall, 86.7% of patients had no hair loss at all. Minimal to moderate hair loss was reported by 13% of patients. Only 0.5% of patients reported complete, though reversible, alopecia.