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Single-Agent Use: Myelosuppression is the principal dose-limiting toxicity with Gemcitabine therapy. Dosage adjustments for hematologic toxicity are frequently needed.
All WHO-graded laboratory events are, regardless of causality. Non-laboratory adverse events discussed as follows were those reported, regardless of causality, for at least 10% of all patients, except the categories of Extravasation, Allergic, and Cardiovascular and certain specific events under the Renal, Pulmonary, and Infection categories.
Hematologic: Gemcitabine can induce bone-marrow suppression, resulting in anemia, leukocytopenia and thrombocytopenia. The bone-marrow suppression is usually mild and mostly affects the granulocyte count. Thrombocytosis is another commonly reported effect. Febrile neutropenia is also commonly reported.
Gastrointestinal: Nausea and vomiting were commonly reported but were usually of mild to moderate severity. Diarrhea and stomatitis.
Hepatic: Gemcitabine was associated with transient elevations of one or both serum transaminases but there was no evidence of increasing hepatic toxicity with either longer duration of exposure to Gemcitabine or with greater total cumulative dose. Serious hepatotoxicity, including liver failure and death, has been reported very rarely in patients receiving Gemcitabine alone or in combination with other potentially hepatotoxic drugs.
Renal: Mild proteinuria and hematuria were commonly reported, but are rarely clinically significant. These conditions are usually not combined with changes in serum creatinine or uremia. However, some cases of renal failure on uncertain etiology have been reported. No cumulative renal toxicity has been observed. Gemcitabine therapy should be discontinued at the first signs of any evidence of microangiopathic hemolytic anemia such as rapidly falling hemoglobin with concomitant thrombocytopenia, elevation of serum bilirubin, serum creatinine, blood urea nitrogen, or LDH. Renal failure may not be reversible even with discontinuation of therapy and dialysis may be required.
Fever: Fever was frequently associated with other flu-like symptoms and was usually mild and clinically manageable.
Rash: A rash can occur and can be associated with itching. The rash is usually mild, and does not necessitate dosage reduction and responds to local therapy. Desquamation, vesiculation and ulceration have occasionally been reported.
Pulmonary: Dyspnea, unrelated to underlying disease, has been reported in association with Gemcitabine therapy. Dyspnea was occasionally accompanied by bronchospasm Pulmonary toxicity has been reported with the use of Gemcitabine. The etiology of these effects is unknown. If such effects develop, Gemcitabine should be discontinued. Early use of supportive care measures may help ameliorate these conditions.
Edema: Edema, peripheral edema and generalized edema were reported.
Flu-like Symptoms: A Flu-like syndrome, which is rarely severe, can occur. It is generally of brief duration and rarely requires a dosage reduction. Individual symptoms of fever, asthenia, anorexia, headache, cough, chills, and myalgia were commonly reported. Fever and asthenia were also reported frequently as isolated symptoms. Insomnia, rhinitis, sweating, and malaise were reported infrequently.
Infection: Infections were reported. Sepsis was rarely reported.
Alopecia: Hair loss, usually minimal.
Extravasation: Injection-site related events were reported. There were no reports of injection site necrosis. Gemcitabine is not a vesicant.
Allergic: Bronchospasm has sometimes been reported. Anaphylactoid reaction has been reported rarely. Gemcitabine should not be administered to patients with a known hypersensitivity to this drug.
Cardiovascular: Cardiovascular events such as myocardial infarction, cerebrovascular accident, arrhythmia, and hypertension have been reported. Many of these patients had a prior history of cardiovascular disease.
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