Gemtabin Adverse Reactions

Hematologic: In studies in pancreatic cancer myelosuppression is the dose-limiting toxicity with gemcitabine, but <1% of patients discontinued therapy for either anemia, leukopenia, or thrombocytopenia. Red blood cell transfusions were required by 19% of patients. The incidence of sepsis was less than 1%. Petechiae or mild blood loss (hemorrhage), from any cause, was reported in 16% of patients; less than 1% of patients required platelet transfusions. Patients should be monitored for myelosuppression during gemcitabine therapy and dosage modified or suspended according to the degree of hematologic toxicity.
Hepatic: In clinical trials, gemcitabine HCl was associated with transient elevations of one or both serum transaminases in approximately 70% of patients, but there was no evidence of increasing hepatic toxicity with either longer duration of exposure to gemcitabine HCl or with greater total cumulative dose. Serious hepatotoxicity, including liver failure and death, has been reported very rarely in patients receiving gemcitabine HCl alone or in combination with other potentially hepatotoxic drugs.
Gastrointestinal: Nausea and vomiting were commonly reported (69%) but were usually of mild to moderate severity. Severe nausea and vomiting occurred in <15% of patients. Diarrhea was reported by 19% of patients, and stomatitis by 11% of patients.
Respiratory: In clinical trials, dyspnea, unrelated to underlying disease, has been reported in association with gemcitabine HCl therapy. Dyspnea was occasionally accompanied by bronchospasm. Pulmonary toxicity has been reported with the use of gemcitabine HCl. The etiology of these effects is unknown. If such effects develop, gemcitabine HCl should be discontinued. Early use of supportive care measures may help ameliorate these conditions.
Renal: In clinical trials, mild proteinuria and hematuria were commonly reported. Clinical findings consistent with the Hemolytic Uremic Syndrome (HUS) were reported in 6 of 2429 patients (0.25%) receiving Gemcitabine HCl in clinical trials. Four patients developed HUS on Gemcitabine HCl therapy, 2 immediately post-therapy. The diagnosis of HUS should be considered if the patient develops anemia with evidence of microangiopathic hemolysis, elevation of bilirubin or LDH, reticulocytosis, severe thrombocytopenia, and/or evidence of renal failure (elevation of serum creatinine or BUN). Gemcitabine HCl therapy should be discontinued immediately. Renal failure may not be reversible even with discontinuation of therapy and dialysis may be required.
Allergic: Bronchospasm was reported for less than 2% of patients. Anaphylactoid reaction has been reported rarely. Gemcitabine HCl should not be administered to patients with a known hypersensitivity to this drug.
Cardiovascular: During clinical trials, 2% of patients discontinued therapy with gemcitabine HCl due to cardiovascular events such as myocardial infarction, cerebrovascular accident, arrhythmia, and hypertension. Many of these patients had a prior history of cardiovascular disease.
Others: Flu-like Symptoms: "Flu syndrome" was reported for 19% of patients. 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. Less than 1% of patients discontinued due to flu-like symptoms.
Infection: Infections were reported for 16% of patients. Sepsis was rarely reported (<1%).
Alopecia: Hair loss, usually minimal, was reported by 15% of patients.
Edema: Edema (13%), peripheral edema (20%), and generalized edema (<1%) were reported.
Less than 1% of patients discontinued due to edema.
Extravasation: Injection-site related events were reported for 4% of patients. There were no reports of injection site necrosis. Gemcitabine is not a vesicant.
Neurotoxicity: There was a 10% incidence of mild paresthesias and a <1% rate of severe paresthesias.