Gemtero Warnings

Prolongation of the infusion time and increased dosing frequency have been shown to increase toxicity.
Gemcitabine can suppress bone marrow function as manifested by leucopenia, thrombocytopenia and anemia. However, myelosuppression is short lived and usually does not result in dose reductions and rarely in discontinuation. Gemcitabine should be discontinued at the first signs of any evidence of microangiopathic haemolytic anemia such as rapidly falling hemoglobin with concomitant thrombocytopenia, elevation of serum bilirubin, serum creatinine, blood urea nitrogen, or LDH, which may indicate development of hemolytic uremic syndrome. Renal failure may not be reversible, even with discontinuation of therapy, and dialysis may be required.
Serious spontaneous reports of haemolytic uremic syndrome (HUS), capillary leak syndrome (CLS), adult respiratory distress syndrome (ARDS), and posterior reversible encephalopathy syndrome (PRES) with potentially severe consequences have been reported in patients receiving Gemcitabine as single agent or in combination with other chemotherapeutic agents. These events can be related to vascular endothelial injury possibly induced by Gemcitabine. Gemcitabine should be discontinued and supportive measures implemented if any of these develop during therapy.
In addition to ARDS, other severe pulmonary effects such as interstitial pneumonitis and pulmonary edema have been reported in patients receiving Gemcitabine as single agent or in combination with other chemotherapeutic agents. Gemcitabine should be discontinued and supportive measures provided if these effects develop during therapy.