Gemtero Special Precautions

General: Patients receiving therapy with Gemcitabine must be monitored closely. Laboratory facilities should be available to monitor patient status. Treatment for a patient compromised by drug toxicity may be required.
Laboratory test: Therapy should be started cautiously in patients with compromised bone marrow function. As with other oncolytics, the possibility of cumulative bone marrow suppression when using combination or sequential chemotherapy should be considered. Patients receiving Gemcitabine should be monitored prior to each dose for platelet, leucocyte and granulocyte counts. Suspension or modification of therapy should be considered when drug induced marrow depression is detected. Peripheral blood counts may continue to fall after the drug is stopped. Laboratory evaluation of renal and hepatic function should be performed periodically. 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.
Interaction with radiotherapy: Concurrent (given together or ≤ 7 days apart): Toxicity associated with this multimodality therapy is dependent on many different factors, including dose of Gemcitabine, frequency of Gemcitabine administration, dose of radiation, radiotherapy planning technique, the target tissue, and target volume. Gemcitabine has radiosensitizing activity. Significant toxicity in the form of severe, and potentially life-threatening mucositis, especially esophagitis and pneumonitis was observed, particularly in patients receiving large volumes of radiotherapy (median treatment volumes 4,795 cm³). The optimum regimen for safe administration of Gemcitabine with therapeutic doses of radiation has not yet been determined.
Non-concurrent (given > 7 days apart): Analysis of the data does not indicate any enhanced toxicity when Gemcitabine is administered more than 7 days before or after radiation other than radiation recall. Data suggest that Gemcitabine can be started after the acute effects of radiation have resolved or at least one week after radiation. Radiation injury has been reported on targeted tissues (e.g. esophagitis, colitis and pneumonitis) in association with both concurrent and non-concurrent use of Gemcitabine.
Effects on ability to drive and use machines: Gemcitabine has been reported to cause mild to moderate somnolence. Patients should be cautioned against driving or operating machinery until it is established that they do not become somnolent.
Use in pregnancy and lactation: The safety of this medicinal product for use in human pregnancy has not been established. The use of Gemcitabine should be avoided in pregnant or nursing women because of the potential hazard to the fetus or infant.