Gemvex-200/Gemvex-1000 Special Precautions

Patients receiving gemcitabine must be closely monitored. A medical laboratory must check their biological parameters. Treatment may be required if the drug produces any toxic effects. In patients with impaired bone-marrow function, the treatment should be started with caution. As with other cytotoxic treatments, the risk of cumulative bone-marrow aplasia must be considered when gemcitabine treatment is given together with other chemotherapy. Patients receiving gemcitabine must undergo haematological tests including blood cells and platelet count before each administration. It may be necessary to suspend or alter the treatment if bone-marrow toxicity induced by the drug is detected. Peripheral blood levels may continue to deteriorate after treatment has been stopped. Gemcitabine must be used with caution in patients with liver failure as no studies have been done in patients with hepatic impairment. Administration of Gemcitabine in patients with concurrent liver metastases or a pre-existing medical history of hepatitis, alcoholism, or liver cirrhosis may lead to exacerbation of the underlying hepatic insufficiency. Renal failure with creatinine clearance between 30 ml/min and 80 ml/min has no significant effect on the pharmacokinetics of gemcitabine. The use of gemcitabine should be avoided in pregnant or nursing women.