Eposide

Eposide is indicated for:

• Cancer

The following information on side effects is based on both oral and intravenous use of Toposide as a single agent, using several different dose schedules for the treatment of a wide variety of malignancies. Hematologic toxicity: Myelosuppression is dose related and dose limiting. Granulocyte nadirs occur 7 to 14 days after the drug is given, and platelet nadirs occur 9 to 16 days after the drug is given. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported. Acute leukemia, with or without a preleukemic phase, has rarely been reported in patients treated with Toposide together with other antineoplastic agents. Gastrointestinal toxicity: Nausea and vomiting are the main gastrointestinal toxicities. They are generally mild to moderate, and treatment has to be stopped in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy. Mild to severe mucositis or esophagitis may occur. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion. Hypotension: Transient hypotension following rapid intravenous administration has been reported in 1% to 2% of patients. It has not been associated with cardiac toxicity or electrocardiographic changes, and no delayed hypotension has been noted. To prevent this rare occurrence, Toposide should be given by slow intravenous infusion over 30 to 60 minutes. If hypotension occurs, it usually responds to stopping the infusion and giving fluids or other supportive therapy as appropriate. When the infusion is restarted, a slower rate should be used. Allergic reactions: Anaphylactic-like reactions, characterized by chills, fever, tachycardia, bronchospasm, dyspnea and/or hypotension, have been reported in 0.7% to 2% of patients receiving intravenous Toposide and in less than 1% of patients treated with the oral capsules. These reactions have usually responded promptly to stopping the infusion and giving pressor agents, corticosteroids, antihistamines or volume expanders as appropriate; however, the reactions can be fatal. Hypertension and/or flushing have also been reported. Blood pressure usually returns to normal within a few hours after the infusion is stopped. Anaphylactic-like reactions have occurred during the initial infusion of Toposide. Facial or tongue swelling, coughing, diaphoresis, cyanosis, tightness in the throat, laryngospasm, back pain and/or loss of consciousness have sometimes occurred along with these reactions. In addition, an apparent hypersensitivity-associated apnea has rarely been reported. Rash, urticaria and/or pruritus have infrequently been reported at recommended doses. At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported. Alopecia: Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients. Other toxicities: The following adverse reactions have been reported infrequently: abdominal pain, aftertaste, constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness, optic neuritis, interstitial pneumonitis or pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis.