"The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
The following data on adverse reactions are based on both oral and intravenous administration of VePesid (etoposide) as a single agent, using several different dose schedules for treatment of a wide variety of malignancies.
Myelosuppression is dose related and dose limiting, with granulocyte nadirs occurring 7 to 14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. 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.
The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with VePesid (etoposide) in association with other antineoplastic agents. (See WARNINGS.)
Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy. Mild to severe mucositis/esophagitis may occur. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion.
Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea, and/or hypotension have been reported to occur in 0.7% to 2% of patients receiving intravenous VePesid (etoposide) and in less than 1% of the patients treated with the oral capsules. These reactions have usually responded promptly to the cessation of the infusion and administration of 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 normalizes within a few hours after cessation of the infusion. Anaphylactic-like reactions have occurred during the initial infusion of VePesid (etoposide) .
Facial/tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm, back pain, and/or loss of consciousness have sometimes occurred in association with the above reactions. In addition, an apparent hypersensitivity-associated apnea has been reported rarely.
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.
Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients.
The following adverse reactions have been infrequently reported: abdominal pain, aftertaste, constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness, optic neuritis, interstitial pneumonitis/pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, and toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis.
Hepatic toxicity, generally in patients receiving higher doses of the drug than those recommended, has been reported with VePesid (etoposide) . Metabolic acidosis has also been reported in patients receiving higher doses.
The incidences of adverse reactions in the table that follows are derived from multiple data bases from studies in 2,081 patients when VePesid (etoposide) was used either orally or by injection as a single agent.
|ADVERSE DRUG EFFECT||PERCENT RANGE OF REPORTED INCIDENCE|
|Leukopenia (less than 1,000 WBC/mm3)||3-17|
|Leukopenia (less than 4,000 WBC/mm3)||60-91|
|Thrombocytopenia (less than 50,000 platelets/mm3)||1-20|
|Thrombocytopenia (less than 100,000 platelets/mm3)||22-41|
|Nausea and vomiting||31-43|
Read the VePesid (etoposide) Side Effects Center for a complete guide to possible side effects
High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease in total body clearance of etoposide compared to etoposide alone.
Periodic complete blood counts should be done during the course of VePesid (etoposide) treatment. They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy. At least one determination should be done prior to each dose of VePesid (etoposide) .
In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance:
|Measured Creatinine Clearance||>50 mL/min||15-50 mL/min|
|etoposide||100% of dose||75% of dose|
Subsequent VePesid (etoposide) dosing should be based on patient tolerance and clinical effect.
Data are not available in patients with creatinine clearances <15 mL/min and further dose reduction should be considered in these patients.
Read the VePesid Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/18/2008
Additional VePesid Information
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