Gemcitabine Disease Interactions

Because of their cytotoxic effects on rapidly proliferating tissues, antineoplastic agents frequently can, to varying extent, induce myelosuppression. The use of these drugs may be contraindicated in patients with known infectious diseases. All patients should be instructed to immediately report any signs or symptoms suggesting infection such as fever, sore throat, or local infection during antineoplastic therapy. Close clinical monitoring of hematopoietic function is recommended.

Cardiovascular events such as myocardial infarction, arrhythmia, and hypertension have been reported during gemcitabine therapy. Therapy with gemcitabine should be administered cautiously in patients with cardiovascular dysfunction.

Hemolytic uremic syndrome (HUS), including fatalities from renal failure or the requirement for dialysis can occur in patients treated with gemcitabine. Renal function should be assessed prior to treatment initiation. Gemcitabine should be permanently discontinued in patients with HUS or severe renal impairment. Renal failure may not be reversible even with discontinuation of therapy.

Gemcitabine induces dose-related myelosuppression. Leukopenia, thrombocytopenia, and anemia have been reported during gemcitabine therapy. Patients should be instructed to immediately report any signs or symptoms suggesting bone marrow suppression such as fever, sore throat, local infection, or bleeding. Therapy should be administered cautiously and dosage modification considered in patients with bone marrow suppression. Close clinical monitory of hematopoietic function is recommended.

Cerebrovascular accidents have been reported during gemcitabine therapy. Therapy with gemcitabine should be administered cautiously in patients with known cerebrovascular disease.

Edema has been reported frequently during gemcitabine therapy. Therapy with gemcitabine should be administered cautiously in patients adversely affected by fluid retention.

Drug induced liver injury, including liver failure and death, has been reported in patients receiving gemcitabine for injection alone or in combination with other hepatotoxic drugs. Administration of gemcitabine in patients with concurrent liver metastases or preexisting medical history of hepatitis, alcoholism, or liver cirrhosis can lead to exacerbation of any underlying hepatic insufficiency. Hepatic function should be assessed prior to initiation of therapy and during treatment. The manufacturers state that no clinical studies have been conducted with gemcitabine in patients with decreased hepatic function.

Mild paresthesias and rare severe paresthesias have been reported during gemcitabine therapy. Therapy with gemcitabine should be administered cautiously in patients with or predisposed to neurological dysfunction.

Pulmonary toxicity, including interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and adult respiratory distress syndrome (ARDS) has been reported with the use of gemcitabine. In some cases, these pulmonary events can lead to fatal respiratory failure despite treatment discontinuation. Caution is advised if using in patients with history of pulmonary disease. Continuous monitoring of pulmonary function is advised.

No clinical studies have been conducted with gemcitabine in patients with decreased renal function. Caution is advised if used in these patients.